Author Interviews, Kidney Disease / 03.12.2020

MedicalResearch.com Interview with: Khurram Jamil, MD Vice President, Clinical Research in Hepatology Critical Care Division, Mallinckrodt MedicalResearch.com: What is the background for the new data of terlipressin presented during Kidney Week 2020 Reimagined? Would you briefly describe hepatorenal syndrome type 1? Whom does it affect and how frequently does it progress to ESRD? Response:  Results from two post-hoc analyses of terlipressin, an investigational agent in the U.S. for adults with hepatorenal syndrome type 1 (HRS-1), were presented at Kidney Week 2020 Reimagined, the annual meeting of the American Society of Nephrology. The first was an oral presentation titled, “Terlipressin Improves Renal Replacement Therapy–Free Survival in Hepatorenal Syndrome Type 1” and included a pooled post-hoc analysis to assess the incidence of renal replacement therapy (RRT) and its impact on survival among patients from three Phase 3 trials. The second was a poster presentation titled, “Treatment of Hepatorenal Syndrome Type 1 with Terlipressin Reduces Need for Renal Replacement Therapy After Liver Transplantation,” which focused on a post-hoc analysis of the CONFIRM study and evaluated the need for RRT among patients who had liver transplantation within 90 days of HRS treatment. HRS-1 is an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis.[i] HRS-1 can progress to life-threatening renal failure within days,i and has a median survival time of approximately two weeks and greater than 80 percent mortality within three months if left untreated.[ii],[iii] It is often a challenge to effectively diagnose in a timely manner due to its diagnosis of exclusion.iii In general, the average patient with hepatorenal syndrome (HRS type 1 or type 2) is in their 50s,[iv] and up to 73 percent of HRS patients are men.[v]  HRS-1 is estimated to affect between 30,000 and 40,000 patients in the U.S. annually.[vi],[vii] (more…)
Annals Internal Medicine, Author Interviews, Kidney Disease, Pediatrics / 12.11.2020

MedicalResearch.com Interview with: Prof. Dr. Hans Pottel PhD Professeur Invité (titre honorifique) Faculté de Médecine Université de Liège KULeuven-KULAK, Kortrijk, Belgium  MedicalResearch.com: What is the background for this study? Why do we need a new GFR? Response: The currently recommended equations have flaws, mainly because there is one equation (CKiD) recommended for children, and one recommended (CKD-EPI) for adults (by KDIGO). When transitioning from pediatric nephrology care to adult nephrology care, the switch from CKiD to CKD-EPI causes implausible jumps (of more than 50%), mainly because CKD-EPI largely overestimates GFR in young adults (18-30 years). The new equation overcomes this problem as it applies for all ages (for children and adults) and overcomes the known flaws of the currently most used equations. The new equation is less biased and more precise across the full age spectrum and for the full range of serum creatinine concentrations. The equation was developed in 11 251 participants from 7 cohorts (development and internal validation datasets) and validated in 8 378 participants from 6 cohorts (external validation dataset). Data were coming from European and American nephrology centers. No patients of African-American ancestry were included. Actually, the previously published FAS-equation served as the basic mathematical form for the equation, but we adjusted the power coefficients for serum creatinine (very much like it was done in the CKD-EPI equation). You could say that we used properties of both the FAS and CKD-EPI equation to come to an improved equation to estimate GFR. (more…)
Author Interviews, Kidney Disease / 16.10.2020

MedicalResearch.com Interview with: Mallika Mendu, MD, MBA MedicalDirector of Clinical Operations Brigham and Women’s Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: African-Americans with chronic kidney disease have poorer outcomes with respect to hypertension control, timely nephrology referral, progression to end stage renal disease, placement of vascular access and transplantation compared to other racial groups. For the past two decades a race multiplier has been applied in equations that estimate glomerular filtration rate (a proxy for kidney function) for African-Americans. We sought to determine whether what the impact of the race multiplier term was on care delivered to African-Americans, by using our health system-wide CKD registry. We were particularly focused on advanced CKD patient outcomes, knowing that there are health disparities that could be potentially exacerbated.

The original CKD-EPI and MDRD studies showed an association between African-American race with higher measured GFR at the same blood creatinine concentration. However, there have been concerns raised about the application of the race multiplier to all African-American patients. First, there is no clear biological explanation for the association, the identification of Black race was unclear in some of the cohorts used in these studies, and there is vast genetic and ancestral heterogeneity among those who self-identify as black. The use of the race multiplier also ignores the fact that race is a social, not biological construct.

We found that with the removal of the race multiplier, up to one in every three African-American patients would be reclassified as having a more severe stage of CKD, with one-quarter of African-American patients going from stage 3 to stage 4. We also found that with the removal of the race multiplier, 64 patients would have had an eGFR <20, the threshold for referral for kidney transplant, and none of these patients were referred, evaluated or waitlisted for transplant. This is in contrast, to those African-American patients with an eGFR <20 with the race multiplier applied, who had a higher odds of being referred, evaluated or waitlisted for transplant compared to other racial groups (Odds ratio of 2.28, compared to White cohort).

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Author Interviews, Kidney Disease, Transplantation / 09.10.2020

MedicalResearch.com Interview with: Jim Gleason, National President of Transplant Recipients International Organization (TRIO), discusses what organ transplant patients are experiencing during the pandemic, and some tips they ought to consider to help ease some of the burden. Mr. Gleason also discusses his role in the development of the recently released AlloCare app is in the AppStore -- https://apps.apple.com/us/app/allocare-transplant-health/id1497962881?ign-mpt=uo%3D2 – to help post-transplant recipients navigate their day-to-day health. MedicalResearch.com: Would you describe your journey with organ transplantation? Mr. Gleason: I was diagnosed with heart failure at the age of 49, 2 years later listed with Penn Medicine in Philadelphia in September of 1994, and received my donor heart on October 19, 1994. After I received my transplant, I was home from the hospital 7 days later and able to return to work in 3 months as a computer manager with Unisys Corp in Blue Bell, PA, where I worked for the next dozen years before my retirement. Once retired, I dedicated my time to raising awareness of the need for organ donation and the success of transplants ever since. Today, 26 active and fulfilled years with my new heart and gift of life, I am able to live life to its fullest at age 77. I am now also coincidentally married to an organ donor of 15 years, who donated her 13-year-old son’s organs when he was hit by a car on his bike back in 1997.  (more…)
Author Interviews, Kidney Disease, Transplantation / 20.07.2020

MedicalResearch.com Interview with: Giacomo Pasini, PhD Professor of Econometrics - Professore ordinario Economics PhD program Director - Coordinatore dottorato in Economia Rector's delegate for Cooperation and Development - Delegato alla Cooperzione per lo sviluppo Economics Department - Dipartimento di Economia Universita' Ca' Foscari - Venezia MedicalResearch.com: What is the background for this study? Response: Kidney transplantation carries several advantages over dialysis treatment for patients with end-stage renal dis-ease (ESRD). Nevertheless, the disparity between the large number of transplant candidates and the scarcity of organs available continues to increase. In order to close this gap selection criteria for donor appropriateness have been widened significantly in recent years to include older persons and those with co-morbidities that could potentially increase the risk of infectious disease transmission (the so-called Expanded Criteria Donors, ECD). The result of kidney transplantation from marginal donors is one of the most topical issues in the transplant literature. (more…)
Author Interviews, Columbia, COVID -19 Coronavirus, Kidney Disease, Transplantation / 09.07.2020

MedicalResearch.com Interview with: Syed Ali Husain, MD, MPH Assistant Professor of Medicine Division of Nephrology, Department of Medicine Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital The Columbia University Renal Epidemiology Group New York, New York  MedicalResearch.com: What is the background for this study? Response: One group of patients thought to be at a high risk of severe COVID-19 manifestations is kidney transplant recipients, since they take medications that suppress their immune system and they often have other medical problems that have been associated with severe infection. We wanted to understand whether it is safe to manage kidney transplant recipients who develop COVID-19 as outpatients, without admitting them to the hospital. (more…)
Author Interviews, Gout, Kidney Disease, NEJM / 24.06.2020

MedicalResearch.com Interview with: Sunil Badve MBBS, MD, DNB, FRACP, PhD, FASN Staff specialist nephrologist | St George Hospital Conjoint Associate Professor | University of New South Wales Senior Research Fellow, Acute Kidney Injury and Trials The George Institute for Global Health Australia  MedicalResearch.com: What is the background for this study? Response: Elevated serum urate levels are associated with progression of chronic kidney disease (CKD). CKD patients often have elevated serum urate levels due to decreased excretion. We conducted this placebo-controlled randomized trial to evaluate if urate-lowering treatment with allopurinol would attenuate decline in estimated glomerular filtration rate (eGFR) over 2 years in patients with CKD. We enrolled 369 CKD patients with high progression risk and no prior history of gout. (more…)
Author Interviews, Dermatology, Kidney Disease / 22.06.2020

MedicalResearch.com Interview with: Gil Yosipovitch, MD, Professor Miami Itch Center Lennar Medical Foundation South Miami Clinic in Coral Gables University of Miami Health System MedicalResearch.com: What is the background for this study? Response: Chronic Pruritus is a common and burdensome condition in patients with end stage chronic kidney disease (CKD). It is Present at all stages of CKD, not only in patients undergoing hemodialysis (including stage 3-5 CKD). There are no approved treatments for this condition in US and Europe. CKD pruritus   has significant impact on quality of life of patients with higher mortality rates due to its effect on sleep. Studies in the last 2 decades have shown that in patients with CKD pruritus there is an imbalance between endogenous mu opioids that are over expressed to Kappa Opioids that are down regulated.   Difelikefalin (DFK) is a novel peripherally selective kappa opioid receptor (KOR) agonist.   Study of IV DFK administration  in hemodialysis patients has  recently  been published and showed significant anti Pruritic effect ( NEJM Fishbane et al. 382: 289-290, 2020). (more…)
Author Interviews, Clots - Coagulation, JAMA, Kidney Disease / 09.06.2020

MedicalResearch.com Interview with: Manish M Sood MD FRCPC MSc Jindal Research Chair for the Prevention of Kidney Disease Associate Professor of Medicine, Dept. of Medicine and the School of Epidemiology and Public Health University of Ottawa Scientist, Ottawa Hospital Research Institute Nephrologist, The Ottawa Hospital Ottawa, Ontario, Canada  MedicalResearch.com: What is the background for this study? Response: Early work has suggested a very commonly used antibiotic, clarithromycin, may interfere with the metabolism of the most widely used type of blood thinning medication (called direct oral anticoagulants or DOACs) such that the blood level of the DOAC increases and may place the patient at a higher risk for bleeding.  In our study we looked at patients of advanced age (>66 years old) who were given clarithromycin while on a DOAC in Ontario, Canada. We compared patients on clairthromycin-DOAC to patients given a very similar antibiotic, azithromycin, that does not interfere with the metabolism of DOAC. (more…)
Author Interviews, JAMA, Kidney Disease, Medicare / 10.04.2020

MedicalResearch.com Interview with: Lead and Senior coauthors contributing to this interview: Abby Hoffman, BA is a Pre-Doctoral Fellow in Population Health Sciences at Duke University and a PhD Candidate in Health Policy and Management University of North Carolina at Chapel Hill. Virginia Wang, PhD, MSPH is an Associate Professor in the Department of Population Health Sciences, Associate Director of the Center for Health Innovation and Outcomes Research, and Core Faculty in the Margolis Center for Health Policy at Duke University and Investigator at the Durham VA HSR&D Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT).   MedicalResearch.com: What is the background for this study? Response: It is well established that healthcare providers are sensitive to changes in price, though their behavioral response varies. Dialysis facilities are particularly responsive to changes in Medicare reimbursement. Many dialysis patients are eligible for Medicare regardless of age, but dialysis facilities generally receive significantly higher reimbursement from private insurers than from Medicare. In 2011, Medicare implemented a new prospective bundled payment for dialysis that was expected to decrease Medicare payment and reduce overall revenues flowing into facilities. Then the Affordable Care Act (ACA) rules against refusing to insure patients for preexisting conditions and the 2014 ACA Marketplace provided an additional avenue for patients to purchase private insurance. As a result of these policies, dialysis facilities had a strong motivation and opportunity to increase the share of patients with private insurance coverage. We were interested in understanding whether dialysis facilities were shifting their payer mix away from Medicare, possibly in response to these policy changes.  (more…)
Author Interviews, Diabetes, Kidney Disease, OBGYNE, Race/Ethnic Diversity / 30.03.2020

MedicalResearch.com Interview with: Silvi Shah, MD, MS, FACP, FNKF, FASN Assistant Professor Division of Nephrology University of Cincinnati Cincinnati, OH-45267 MedicalResearch.com: What is the background for this study? Response: The study identified 42,190,790 pregnancy related hospitalizations between Jan. 1, 2006 and Dec. 31, 2015, using data from the from the Nationwide Inpatient Sample. (more…)
Author Interviews, Kidney Disease, Stem Cells / 27.01.2020

MedicalResearch.com Interview with: Dr. Orit Harari-Steinberg Dr. Dorit Omer Dr. Oren Pleniceanu Prof. Benjamin Dekel The Pediatric Stem Cell Research Institute Sheba Medical Center Tel Hashomer, Israel MedicalResearch.com: What is the background for this study? Response: The motivation behind this study is the rising epidemic of chronic kidney disease (CKD). With a prevalence in some reports of up to 17.3%  and very expensive treatments, especially in its advanced stages, CKD is more common than most people think, and it keeps growing at a very fast rate, due to the increasing number of patients suffering from diabetes and hypertension. At the same time, medicine doesn’t offer good solutions to these patients, with dialysis creating high morbidity and mortality. From the fact that 70,000 cells are shed in the urine each hour, we deduce that the kidney has the ability to form new cells to make up for this loss. In a previous work, we used a mouse model to show that cell clones form and proliferate in the adult kidney, so we know that cells of the adult kidney, or at least a portion thereof, have the ability to multiply in-vivo. It has been possible for quite a while to isolate proliferating cells from human kidneys and grow them in a dish. The problem, however, is that in order to achieve a large enough number of cells capable of regenerating the kidneys, massive expansion is needed ex-vivo, and that's the real obstacle. The reason is that following several passages, the cells lose their phenotype and become senescent, and therefore useless for regenerative purposes. In this study, we developed a unique 3D culturing method, growing the kidney cells in structures which we termed 'nephrospheres'. This culturing method rejuvenated the cells and allowed massive expansion for long periods of time. The positive effect on the cells was evident when we analyzed their transcriptome and found activation of molecular pathways associated with renal epithelial identity and renal tissue-forming capacity. What's even more striking, is that the same effect was seen when we used cells from the kidneys of CKD patients. We were then interested in determining whether these cells might also have a therapeutic effect. Indeed, when we injected these cells into mice with CKD (which was generated by resecting 5/6 of their kidneys), we saw a functional improvement in GFR. When we analyzed the treated kidneys, we found that the injected cell both formed renal tubule-like structures and integrated into existing host tubules, which resulted in a therapeutic effect. So, altogether, this study showed that our culturing method can serve as an effective means of establishing large numbers of autologous cells with regenerative capacity. (more…)
Author Interviews, Gout, Kidney Disease, Rheumatology, Transplantation / 10.11.2019

MedicalResearch.com Interview with: Megan Francis-Sedlak, PhD Director of Medical Affairs Horizon Therapeutics Lake Forest, Illinois MedicalResearch.com: What is the background for this study? Response: The prevalence of gout is more than ten-fold greater among patients who have undergone a kidney transplant than the general population as post-transplant medications to prevent organ rejection can contribute to increased uric acid levels. Overall studies have shown this can lead to higher rates of uncontrolled gout among this vulnerable population with organ transplants. While we have seen higher mortality rates for patients who have received a kidney transplant with uncontrolled gout compared to kidney transplant patients without uncontrolled gout, we wanted to evaluate the impact of gout on transplant-related complications to better inform patient care and treatment approaches.  (more…)
Author Interviews, Genetic Research, Kidney Disease, Mineral Metabolism, Pediatrics / 10.11.2019

MedicalResearch.com Interview with: Tracy McGregor, MD MSCI Alnylam Pharmaceuticals Cambridge, Massachusetts  MedicalResearch.com: What is the background for this study?
  • Lumasiran is an investigational RNA interference (RNAi) therapeutic in development for the treatment of primary hyperoxaluria type 1 (PH1). PH1 is a rare life-threatening disease in which a enzymatic deficiency in the liver results in pathologic overproduction of oxalate, often leading to recurrent kidney stones and a progressive decline in kidney function, which typically culminates in end-stage renal disease (ESRD).Patients with ESRD are at a risk of systemic oxalosis, with oxalate depositing throughout the body, including the eyes, skin, bones, and the heart. Complications associated with ESRD and/or systemic oxalosis can be fatal. For patients with ESRD treatment options are limited and include intensive dialysis as a bridge to a dual liver/kidney transplant, highlighting the unmet need for new treatment options. 
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Author Interviews, Kidney Disease, OBGYNE / 02.10.2019

MedicalResearch.com Interview with: Silvi Shah, MD, MS, FACP, FASN| Assistant Professor Division of Nephrology, University of Cincinnati Cincinnati, OH-45267 MedicalResearch.com: What is the background for this study? Response: Our study uses data from the largest retrospective cohort of dialysis patients in the United States from the United States Renal Data System to determine pregnancy rates and factors associated with pregnancy in 47,555 women aged 15-44 years on dialysis. We identified 2,352 pregnancies with a rate of 17.8 pregnancies per 1000 person-years (PTPY) with the highest rate in women aged 20-24 years (40.9 PTPY). (more…)
Author Interviews, Emory, Health Care Systems, JAMA, Kidney Disease, Transplantation / 11.09.2019

 A retraction and replacement have been issued due to a major coding error that resulted in the reporting of incorrect data in this study surrounding the difference in transplant rates between for-profit and non-profit dialysis centers. Please see link below:

Bauchner H, Flanagin A, Fontanarosa PB. Correcting the Scientific Record—Retraction and Replacement of a Report on Dialysis Ownership and Access to Kidney Transplantation. JAMA. 2020;323(15):1455. doi:10.1001/jama.2020.4368

MedicalResearch.com Interview with: Rachel Patzer, PhD, MPH Associate Professor Director, Health Services Research Center Department of Medicine Department of Surgery Emory University School of Medicine   MedicalResearch.com: What is the background for this study? Response: We know that historically, for-profit dialysis facilities have been shown to have lower rates of kidney transplantation than patients who receive treatment in non-profit dialysis facilities. However, these studies are outdated, and did not examine access to living donor transplantation or include the entirety of the end-stage kidney disease population  (more…)
Author Interviews, JAMA, Kidney Disease, Transplantation / 26.08.2019

MedicalResearch.com Interview with: Alexandre Loupy, MD PhD Nephrologist, Department of Nephrology & Kidney Transplantation Necker Hospital, Paris Head of the Paris Transplant Group (Inserm)  MedicalResearch.com: What is the background for this study? Response: The lack of organs for kidney transplantation is a major public health problem across the world, due to its attributable mortality and excess cost to healthcare systems while waitlisted patients are maintained on chronic dialysis. Nearly 5,000 people in the US and 3,500 people in Europe die each year while waiting for a kidney transplant. Yet in the US, over 3,500 donated kidneys are discarded annually, representing almost 18% of the available organs, while the discard rate in France is only 6,8%, though these countries have similar organ allocation systems and offer the same treatments to patients after transplant. We thus compared the use of donated kidneys in the US to France from 2004-2014 in much more depth, using a new approach based on validated analytic methods and computer simulation.  (more…)
AstraZeneca, Author Interviews, Kidney Disease, Mineral Metabolism / 08.07.2019

MedicalResearch.com Interview with: Steven Fishbane MD Chief, Division of Kidney Disease and Hypertension Vice President, Northwell Health for Network Dialysis Services, Northwell Health Professor of Medicine Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Department of Medicine, Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York  MedicalResearch.com: What is the background for this study? Response: Patients on hemodialysis have a great frequency of hyperkalemia. The hemodialysis treatment removes some potassium but not enough to get rid of this problem. Available medications to bind potassium have not been tested among these patients. The purpose of the study was to see if sodium zirconium cyclosilicate could be used as a potassium binder to reduce the risk of hyperkalemia in patients on a hemodialysis. (more…)
Author Interviews, End of Life Care, JAMA, Kidney Disease / 08.07.2019

MedicalResearch.com Interview with: Dr. Ann M. O’Hare, MD Professor,Division of Nephrology University of Washington Investigator, VA HSR&D Center of Excellence Affiliate Investigator, Group Health Research Institute Seattle, WA  MedicalResearch.com: What is the background for this study? Response: We know that survival for people undergoing dialysis is generally quite limited.  Only a few studies have attempted to elicit how patients undergoing dialysis understand prognosis and how their prognostic awareness might be related to their interest in planning for the future, their preferences for resuscitation and the kind of care they would want if they were seriously ill or dying. (more…)
Author Interviews, Cost of Health Care, Kidney Disease / 03.07.2019

MedicalResearch.com Interview with: "Plugged into dialysis" by Dan is licensed under CC BY 2.0Andrew C. Qi,  Medical student Karen E. Joynt Maddox MD MPH Assistant professor of medicine Washington University School of Medicine Saint Louis, Missouri.  MedicalResearch.com: What is the background for this study?   Response: The End-Stage Renal Disease Quality Incentive Program (ESRD QIP) is a Medicare program that evaluates dialysis facilities in the U.S. based on a set of quality measures, and penalizes low-performing facilities. We’ve seen a growing understanding of how social risk factors like poverty and race/ethnicity impact patient outcomes in other settings, making it difficult for providers caring for disadvantaged populations to perform as well in these kinds of pay-for-performance programs. We were interested in seeing if this was the case for dialysis facilities as well, especially since patients receiving dialysis are already a vulnerable population. (more…)
AstraZeneca, Author Interviews, Diabetes, Kidney Disease / 24.06.2019

MedicalResearch.com Interview with: Naeem Khan MD Vice President at AstraZeneca  MedicalResearch.com: What is the background for this study? What are the main findings? Response: A pre-specified exploratory analysis of renal data from the DECLARE-TIMI 58 trial, the largest SGLT-2 inhibitor (SGLT-2i) cardiovascular outcomes trial (CVOT) conducted to date, showed that FARXIGA (dapagliflozin) reduced the composite of kidney function decline, end-stage renal disease (ESRD) or renal death by 47% in patients with type 2 diabetes (T2D). Additionally, FARXIGA reduced the relative risk of a cardio-renal composite of kidney function decline, ESRD, or renal or cardiovascular (CV) death by 24% compared to placebo. The analysis evaluated 17,160 patients with type 2 diabetes and predominantly preserved renal function, irrespective of underlying atherosclerotic CV disease (ASCVD). (more…)
Author Interviews, JAMA, Johns Hopkins, Kidney Disease, Surgical Research / 13.06.2019

MedicalResearch.com Interview with: Caitlin W. Hicks, M.D., M.S. Assistant Professor of Surgery Recipient of the Department of Surgery Rothman Early Career Development Award for Surgical Research Johns Hopkins Medicine MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Arteriovenous fistula are associated with better long-term patency, lower rates of infection, and lower long-term costs compared to arteriovenous graft. As a result, the Fistula First Catheter Last Guidelines recommend placement of an arteriovenous fistula over an AVG whenever possible. We looked at individual physician utilization of AVF vs AVG for first-time AV access in Medicare beneficiaries. We found that the median physician utilization rate for AVG was only 18%, but that 21% of physicians use AVG in more than 34% of cases, which is above currently recommended  practice guidelines.  (more…)
Author Interviews, JACC, Kidney Disease, NYU / 13.06.2019

MedicalResearch.com Interview with: David Charytan, MD MSc Chief, Nephrology Division NYU Langone Medical Center New York, NY 10010  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Cardiovascular events are much more frequent in patients with impaired kidney function (chronic kidney disease), and cardiovascular disease is the most common cause of death in advanced chronic kidney disease. This risk remains high despite the use of standard medical therapies including statins, the most commonly used cholesterol lowering agents. The PCSK9 inhibitor evolocumab is a new class of highly potent cholesterol lowering medications that can further reduce the risk of cardiovascular events in patients already taking statins. We analyzed data from the FOURIER trial, which randomized study patients with clinically evident atherosclerosis and an LDL cholesterol level >=70 mg/dL or HDL cholesterol level >= while on a statin, to assess the safety and efficacy of evolocumab, a PCSK9 inhibitor, compared with placebo in individuals with mild to moderate chronic kidney disease. There were several major findings
  • a) evolocumab appears to be equally safe in individuals with preserved and mild to moderately impaired kidney function
  • b) evolocumab appears to have preserved efficacy at preventing cardiovascular events as kidney function declines.
  • c) We were unable to detect any significant impact on kidney function.
  • In addition, because the baseline risk of cardiovascular events is much higher in individuals with  chronic kidney disease, the absolute benefits of treatment with evolocumab appear  to be magnified as kidney function declines.  (more…)
Author Interviews, Kidney Disease / 06.06.2019

MedicalResearch.com Interview with: Rita R. Alloway, PharmD, FCCP Research Professor of Medicine Director, Transplant Clinical Research University of Cincinnati College of Medicine, Department of Internal Medicine Division of Nephrology Kidney C.A.R.E. Program (Clinical Advancement, Research & Education) Cincinnati OH 45267  MedicalResearch.com: What is the background for this study? Response: Transplant recipients are required to take lifelong immunosuppression to sustain the function of their transplant.  Unfortunately these immunosuppressants have significant side effects.  The most significant of these side effects are worsening kidney function, hypertension, hypercholesterolemia, post transplant diabetes, tremors and headaches.  Researchers focused on improving post transplant outcomes are looking for immunosuppressant regimens with similar efficacy while minimizing harmful side effects. Tacrolimus and steroids are the immunosuppressants associated with the worst side effect profiles.  This study eliminated both of these immunosuppressants and replace tacrolimus with belatacept.  Belatacept is a once monthly intravenous infusion with a more favorable side effect profile compared to tacrolimus.  In addition, since it is a monthly infusion, adherence can improved compared to an oral medication taken twice daily. (more…)
AstraZeneca, Kidney Disease / 04.06.2019

MedicalResearch.com Interview with: AstraZenecaJill Davis, MS Director, Health Economics and Outcomes Research AstraZeneca  MedicalResearch.com: What is the background for this study? Who is most at risk for hyperkalemia post discharge? Response: In the United States, an estimated 30 million people suffer from chronic kidney disease (CKD), about 3.7 million of which have hyperkalemia (elevated potassium level). Hyperkalemia (HK) can be chronic, so it’s important that those who have been diagnosed with hyperkalemia previously or have CKD have their potassium levels monitored by their healthcare provider. Additionally, although HK is estimated to be prevalent in more than 66,000 emergency department (ED) visits annually, there is limited knowledge about the management of patients with HK in the ED setting and post-discharge. We decided to focus our study to better understand and compare the ED management and post-discharge outcomes among patients with varying levels of hyperkalemia To conduct this study, we analyzed the electronic medical record data from the Research Action for Health Network (2012-2018) of 6,222 adult patients with a randomly selected HK-related ED visit. We concluded that improved management of HK patients in the ED and post-discharge period is needed to reduce the recurrence of hyperkalemia. (more…)
Author Interviews, Cost of Health Care, Kidney Disease, UCLA / 14.05.2019

MedicalResearch.com Interview with: Chris Childers, MD, PhD Division of General Surgery David Geffen School of Medicine at UCLA Los Angeles, CA 90095 MedicalResearch.com: What is the background for this study? Response: Patients with end-stage renal disease – poorly functioning kidneys – often have to receive dialysis. This typically requires a patient to visit an outpatient clinic several times a week to have their blood filtered by a machine. Over the past few years, two for-profit companies have increased their control over the outpatient dialysis market – DaVita and Fresenius. Combined they control approximately ¾ of the market.  A number of concerns have been raised against these for-profit companies suggesting that the quality of care they deliver may be worse than the care delivered at not-for-profit companies. But, because they control so much of the market and because patients have to receive dialysis so frequently, patients may not have much choice in the clinic they visit. Medicare covers patients who are 65 years or older and also patients on dialysis regardless of age.  Medicare pays a fixed rate for dialysis which they believe is adequate to cover the clinics' costs. However, if a patient also has private insurance, the insurer is required to pay for dialysis instead of Medicare. Whereas Medicare rates are fixed by the federal government, private insurers have to negotiate the price they pay, and may pay much more as a result. (more…)
Author Interviews, Geriatrics, Kidney Disease / 05.05.2019

MedicalResearch.com Interview with: Dr. Luciano da Silva Selistre MD MS PhD Professor de Medicina - UCS MedicalResearch.com: What is the background for this study? What are the main findings? Response:   We have found that no equation for estimating renal function in the elderly is fully accurate. There are important mistakes between them. (more…)
Author Interviews, Kidney Disease, Pharmaceutical Companies / 26.04.2019

MedicalResearch.com Interview with: Dr. Jay Venkatesan MD President and CEO of Angion Dr. Venkatesan discusses the recent announcement that ANGION, has received DOD funding for the study of ANG-3070, in treatment of CKD caused by focal segmental glomerulosclerosis,  MedicalResearch.com: What is the background for this announcement? Would you tell us a little about focal segmental glomerulosclerosis (FSGS)? How does ANG-3070 work to prevent kidney scarring? Response: Angion has received a follow-on grant from the Department of Defense (DoD) for $4.76 million in support of the development of ANG-3070, our drug candidate for a form of chronic kidney disease known as focal segmental glomerulosclerosis (FSGS). This funding will allow us to expand our proof-of-concept data for ANG-3070 as a potential anti-fibrotic agent for slowing the progression of FSGS. FSGS is a serious kidney disorder characterized by progressive scarring of the glomeruli, the filtering units of the kidney. There are approximately 80,000 cases of FSGS in the U.S. and Europe, involving both children and young adults. If uncontrolled, FSGS can lead to kidney failure, which may lead to the need for dialysis or a kidney transplant. No therapies exist that treat the underlying cause of FSGS. Therapies such as corticosteroids, immunosuppressants or diuretics  are used, but are mainly supportive and a large proportion of patients progress to end-stage renal disease over a 5-10 year period of time. ANG-3070 is an oral small molecule that selectively inhibits molecular pathways associated with scarring or fibrosis in the kidney and other organs. Our current preclinical study in collaboration with NEPTUNE aims to identify the “signalosome,” or human disease and drug response profile based on the genes, networks and pathways that correlate with the therapeutic activity of ANG-3070 in FSGS. Ultimately, this collaboration will allow us to  develop a precision medicine approach to identify and treat patients in whom ANG-3070 is most likely to block the pathways causing FSGS.  (more…)
Author Interviews, JAMA, Kidney Disease / 08.04.2019

MedicalResearch.com Interview with: Matthew T James MD, PhD Assistant Professor University of Calgary  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The Acute Kidney Disease and Disorders (AKD) criteria from the KDIGO Acute Kidney Injury guidelines identified many patients who do not meet existing criteria for Chronic Kidney Disease or Acute Kidney Injury (AKI), and the majority of AKD events occured in the community rather than hospital setting. This study characterized the frequency and outcome for patients with AKD (without  AKI) as well as AKD with CKD from among over 1.1 million adults  residing in Alberta Canada who received  kidney function testing and were followed for up to 8 years. (more…)
Author Interviews, Kidney Disease / 05.04.2019

MedicalResearch.com Interview with: Rudolf Lucas, PhD Professor Pharmacology and Toxicology Vascular Biology Center, Division of Pulmonary Medicine Michael P. Madaio, MD Sydenstricker Professor and Chairman Department of Medicine Medical College of Georgia Augusta University Augusta, Georgia 30912, USA.   MedicalResearch.com: What is the background for this study? Response: The pro-inflammatory cytokine tumor necrosis factor (TNF) is a crucial mediator of glomerulonephritis, but the cytokine is also important in defense to bacterial infections. As such, chronically inhibiting TNF, using soluble TNF receptor constructs or neutralizing anti-TNF antibodies can promote infection. In this study, we wanted to develop a novel therapeutic strategy to specifically inhibiting deleterious TNF signaling, while preserving the beneficial anti-bacterial actions of the cytokine. (more…)