MedicalResearch.com Interview with: John W. Stanifer, MD MSc Duke Health MedicalResearch.com: What is the background for this study? What are the main findings? Response:...
Dr. Roediger[/caption]
Ben Roediger PhD
Head of the Skin Inflammation Group within
Professor Wolfgang Weninger’s Immune Imaging Laboratory
Centenary Institute, Faculty of Medicine and Health,
The University of Sydney,
Camperdown,, Australia
MedicalResearch.com: What is the background for this study?
Response: We use several strains of mice for our research, including animals with immunodeficiencies. One of our lines started succumbing to kidney disease and we decided to investigate.
Coffee
Dr Salas[/caption]
Rachel Marie E. Salas, MD, MEHP, FAAN
Associate Professor, Neurology and Nursing at Johns Hopkins Medicine
Director, Interprofessional Education and Interprofessional Collaborative Practice
Director, Neurology Clerkship
Director, PreDoc Program Meyer/Neuro Sleep
Baltimore, MD
MedicalResearch.com: What is the background for this study? Can you briefly describe what is meant by RLS and who suffers from it?
Response: Restless Legs Syndrome (RLS) is a common neurological disorder characterized by an irritating, overwhelming urge to move (akathisia) the legs while at rest or sleep (conditions of diminished arousal), which almost immediately abates with mental or physical activity (conditions of maintained arousal).
One of the most clinically-profound and scientifically relevant consequences of this disease process is an increased arousal state producing significant wake during sleep times and a relative sustainable degree of daytime alertness despite the degree of diseased-imposed sleep loss. The focus of most previous RLS research has been on the (limb) akathisia with associated periodic movements and reduction of these with dopaminergic treatment. Little research has been done to understand the broader biological dimensions of RLS. Patients with RLS have altered sleep-wake homeostasis with increased arousal and wakefulness (hyperarousal) not only driving the signature clinical symptoms (“the urge to move” and sleep loss) but also supporting arousal over sleep drive at night and in the day. We hypothesize that there is a basic glutamate-hyperarousal process producing both disrupted sleep (increased wake time) and cortical excitability (as demonstrated by transcranial magnetic stimulation (TMS)). 
Dr. Muller[/caption]
Dr. David C. Muller PhD
Faculty of Medicine, School of Public Health
Research Fellow in Epidemiology and Biostatistics
Imperial College, London
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Our colleagues in the U.S. have been working on KIM-1 for years, particularly in the context of chronic kidney disease. Recently they found that KIM-1 is also elevated at the time of diagnosis of kidney cancer.
We wanted to see if KIM-1 concentrations could predict the chances of a future diagnosis of kidney cancer. We found that KIM-1 was a strong predictor of being diagnosis with kidney cancer in the next 5 years. We also found that higher pre-diagnostic KIM-1 was associated with worse survival after diagnosis. 
Dr. Madaio[/caption]
Michael P. Madaio, MD
Sydenstricker Professor and Chairman
Department of Medicine
Medical College of Georgia at
Augusta University
MedicalResearch.com: What is the background for this study?
Response: Glomerulonephritis is a inflammatory disease of the kidney. Glomeruli are the filtering units in the kidney. This is most often immunologically mediated and are autoimmune.
Most therapies are directed at inhibiting the Immune/autoimmune process (immunotherapy) systemically.
Dr. Eckman[/caption]
Mark H. Eckman, MD
Posey Professor of Clinical Medicine
Director, Division of General Internal Medicine
Director, Center for Clinical Effectiveness
University of Cincinnati Medical Center
Cincinnati, OH
MedicalResearch.com: What is the background for this study?
Response: People who are infected with hepatitis C virus and have kidney failure need a kidney transplant.
Recent studies have found that it is possible to transplant kidneys from donors who are infected with hepatitis C virus into patients who need a transplant and are already infected with the virus. In addition, drugs are available to cure most patients of hepatitis C virus, including those who have kidney failure. Infected patients who need a kidney transplant have 2 options. One option is to receive an infected kidney and then use drugs after the transplant to cure themselves and the transplanted kidney of the virus. Another option is to use the drugs first to get rid of the virus and then to receive a kidney from a donor who does not have hepatitis C virus infection.
For the more than 500,000 patients receiving dialysis for end-stage renal disease (ESRD), less than 4% receive kidney transplants. Because of the limited organ availability, hemodialysis is the final treatment for most patients with ESRD. Of the 10% or so of U.S. patients receiving dialysis who are infected with the hepatitis C virus (HCV), some are willing to accept HCV-infected kidneys, in part, because the wait times for such kidneys are shorter than those for HCV-uninfected kidneys. Because the yearly mortality rate for patients receiving hemodialysis is so high, between 4% and 16%, reducing the time to kidney transplant can have a dramatic effect on both survival and quality of life.
Because it may not be possible to do this type of research with actual people, we created a model that allowed us to estimate possible outcomes without using actual people.
The model was a computer program that combined the best available information to approximate what might happen to participants in a real-world clinical trial.
Prof. O'Hare[/caption]
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? What are the main findings?
Response: We set out to conduct a qualitative study among patients with advanced kidney disease to learn about their thoughts and experience with advance care planning.
Our questions, especially at the beginning of the interview were quite broad and asked patients more generally about their experiences of illness and care. Although we did not ask patients about the emotional impact of illness and care, this came across as a strong theme when we analyzed the interviews, and that is what we describe here.
Dr. Talenfeld[/caption]
Adam Talenfeld, M.D
Assistant Professor of Radiology
Weill Cornell Medical College
Assistant Attending Radiologist
New York-Presbyterian Hospital.
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: We know that renal function decreases as we age, and we know that decreased renal function is independently associated with increased mortality. This is why medical society guidelines recommend partial nephrectomy, which preserves kidney tissue and function, over radical nephrectomy for the treatment of the smallest kidney cancers, stage T1a tumors, which are under 4 cm diameter. Paradoxically, though, we know older patients are more likely than younger patients to receive radical nephrectomy for these smallest tumors, probably because it’s a simpler surgery than partial nephrectomy.
Percutaneous ablation, focal tissue destruction using heat or cold emanating from the tip of a needle, is a newer, image-guided, minimally-invasive, tissue-sparing treatment for solid organ tumors. We wanted to test how well percutaneous ablation would compare to partial nephrectomy and radical nephrectomy for these smallest kidney cancers.
We found that percutaneous ablation was associated with similar 5-year overall and cancer-specific survival compared to radical nephrectomy. At the same time, ablation was associated with significantly lower rates of new-onset chronic renal insufficiency and one-fifth as many serious non-urological complications than radical nephrectomy within 30 days of treatment. These were complications, such as deep venous thrombosis or pneumonia, that resulted in emergency department visits or new hospital admissions. The outcomes of percutaneous ablation compared with partial nephrectomy were somewhat less clear, though ablation was again associated with fewer perioperative complications.
Dr. Ishida[/caption]
Dr. Julie H. Ishida MD
Department of Medicine, Division of Nephrology
University of California, San Francisco and
San Francisco Veterans Affairs Medical Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Gabapentin and pregabalin are used for the management of symptoms such as neuropathic pain, itching, and restless leg syndrome in patients receiving hemodialysis. However, hemodialysis patients may be particularly vulnerable to adverse events related to these agents, which are cleared by the kidney, but there is limited data evaluating their risk in this population.
Gabapentin and pregabalin use were associated with risk for altered mental status, fall, and fracture, and in some cases, even at doses that would be considered safe for use in this population. 
Dr. Fishbane[/caption]
Steven Fishbane, MD,
Chief, Division of Kidney Disease and Hypertension, Northwell Health
Vice President, Northwell Health for Network Dialysis Services, Northwell Health
Professor of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
Lead investigator of the ZS 005 study
MedicalResearch.com: What is the background for this announcement? Would you briefly explain what is meant by hyperkalemia?What are the dangers of an elevated potassium and how does LOKELMA differ from prior standard treatments?
Response: Hyperkalemia is when the potassium in the blood rises to potentially harmful levels. High potassium is primarily harmful for the heart. As the potassium level rises the risk for abnormal electrical rhythms or disruption of the heart’s pumping occur. When severe, a high potassium level can cause death.
Lokelma has been demonstrated to be effective for lowering potassium levels with a great degree of consistency. It is well tolerated and has a fairly rapid onset of potassium lowering compared to other drugs for the purpose. 
Dr. Cervantes[/caption]
Lilia Cervantes, M.D.
Internal Medicine, Hospitalist
Denver Health and Hospital Authority
Assistant Professor, Division of General Internal Medicine
Founder, Healthcare Interest Program and Health Equity Lecture Series
at Denver Health
University of Colorado Health Sciences Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: For most undocumented immigrants with kidney failure in the U.S., access to hemodialysis is limited and they can only receive it when they are critically ill and near-death. This type of “emergency-only” hemodialysis is already known to be nearly 4-fold more costly, has 14-fold higher mortality rate, and leads to debilitating physical and psychosocial distress for these patients compared to those receiving regular hemodialysis.
This study shows that clinicians who are forced to provide this substandard care are also harmed. They experience moral distress, emotional exhaustion, and several other drives of professional burnout due to witnessing needless suffering and high mortality. 
Dr. William Clark
Lawson Health Research Institute
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This study is about the use of increased water intake in people with chronic kidney disease (CKD).
Although there are a large number of benefits claimed most are not substantiated by evidence. However there is a growing body of evidence (animal and human observational studies) that increased hydration with the suppression of antidiuretic hormone preserves kidney function in CKD. This led to our current randomised clinical trial of 631 patients with stage 3 CKD and proteinuria to determine if drinking an extra 4-6 glasses of water per day for 1 year would slow their progressive loss of kidney function as measured by eGFR.
The main findings were that those coached to increase their water intake versus those coached to sustain their normal fluid intake suffered no ill effects from the intervention and on average were able to sustain an average increase of approximately 3 glasses of water per day. At the end of 1 year the increased hydration group had suppressed their antidiuretic hormone levels (copeptin) significantly but did not demonstrate a greater preservation in their eGFR.
Dr. Foster[/caption]
Bethany J. Foster, MD MSCE
Montreal Children’s Hospital
Department of Pediatrics,
Department of Epidemiology, Biostatistics, and Occupational Health
McGill University, Montreal, QC, Canada
MedicalResearch.com: What is the background for this study?
Response: Adolescent and young adult kidney transplant recipients have the highest risk of graft loss of any age group. One of the main reasons for this is not taking their anti-rejection medications as prescribed. Our study had the goal of testing an intervention to try to improve young patients' adherence to their strict medication schedule. The intervention included feedback of how well they were taking their medications (which was monitored electronically), text message reminders for medication doses, and individualized coaching to address their personal barriers to taking their medications.
Dr. Self[/caption]
Wesley H. Self, MD, MPH
Associate Professor
Department of Emergency Medicine
Vanderbilt University Medical Center
Nashville, TN
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Doctors have been giving IV fluids to patients for more than 100 years. The most common IV fluid during this time has been saline; it has high levels of sodium and chloride in it (similar to table salt). Balanced fluids are an alternative type of IV fluid that has lower levels of sodium and chloride that are more similar to human blood.
Our studies were designed to see if treating patients with these balanced fluids resulted in better outcomes than saline. We found that patients treated with balanced fluids had lower rates of death and kidney damage than patients treated with saline.
Dr. Alban[/caption]
Rodrigo F. Alban, MD FACS
Associate Director Performance Improvement
Associate Residency Program Director
NSQIP Surgeon Champion
Department of Surgery
Cedars-Sinai Medical Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Continuous Renal Replacement Therapy (CRRT) is a modality of hemodialysis commonly used to manage renal failure in critically ill patients who have significant hemodynamic compromise. However, it is also resource-intensive and costly and its usage is highly variable and lacks standardization.
Our institution organized a multidisciplinary task force to target high value care in critically ill patients requiring CRRT by standardizing its process flow, promoting cross-disciplinary discussions with patients and family members, and increasing visibility/awareness of CRRT use. After our interventions, the mean duration of CRRT decreased by 11.3% from 7.43 to 6.59 days per patient. We also saw a 9.8% decrease in the mean direct cost of CRRT from $11642 to $10506 per patient. Finally, we also saw a decrease in the proportion of patients expiring on CRRT, and an increase in the proportion of patients transitioning to comfort care.
L-R: Kerry Chen, Anita van Zwieten, Madeleine Didsbury, Germaine Wong[/caption]
Dr. Kerry Chen
Centre for Kidney Research, The Kids Research Institute
The Children’s Hospital at Westmead, Sydney School of Public Health,
The University of Sydney
Sydney, New South Wales, Australia
MedicalResearch.com: What is the background for this study?
Response: Chronic kidney disease is a major public health issue, with end-stage disease often requiring a combination of complex medication regimens, dialysis and/or transplant surgery. In children, the major causes of CKD are genetic and congenital. The consequences of CKD in children can be long-term and debilitating especially as they transition into adulthood, affecting their physical, intellectual and emotional well-being.
To better understand these changes, the Kids Health and Wealth Study (KCAD) is the largest longitudinal cohort study of children and adolescents with CKD in Australia and New Zealand. Spread across 5 paediatric nephrology centres so far, the KCAD Study takes a life-course approach to collecting and analysing data pertaining to the interactions between reduced renal function and associated clinical, socio-economic, quality of life, psychological, cognitive and educational outcomes in children, especially as they progress in CKD stage and also as they transition into adulthood.
Dr. Nowak[/caption]
Dr. Kristen L. Nowak PhD
Division of Renal Diseases and Hypertension
University of Colorado Anschutz Medical Campus
Aurora, CO 80045
MedicalResearch.com: What is the background for this study?
Response: Subtle impairments in cognition are common with aging, even in the absence of clinically apparent dementia. Mild hyponatremia is a common finding in older adults; however, the association of lower serum sodium with cognition in older adults is currently uncertain.
We hypothesized that lower normal serum sodium would be associated with prevalent cognitive impairment and the risk of cognitive decline over time in asymptomatic, community-dwelling older men.
Hemodialysis machine[caption id="attachment_39693" align="alignleft" width="200"] Emanuele Di Angelantonio[/caption] MedicalResearch.com Interview with: Emanuele Di Angelantonio MPhl Department of Public Health and Primary Care School of Clinical...
Dr. Purnell[/caption]
Tanjala S. Purnell, PhD MPH
Assistant Professor of Surgery, Epidemiology, and Health Behavior and Society
Core Faculty, Epidemiology Research Group in Organ Transplantation
Johns Hopkins University
Associate Director for Education and Training, Johns Hopkins Center for Health Equity
Member, OPTN/UNOS Minority Affairs Committee
MedicalResearch.com: What is the background for this study?
Dr. Courtney[/caption]
Kevin D. Courtney, M.D., Ph.D.
Assistant Professor
UT Southwestern Medical Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Clear cell renal cell carcinoma (ccRCC) is the most common form of kidney cancer. Metastatic ccRCC does not respond to traditional chemotherapy.
Current standard treatments for metastatic ccRCC include drugs called vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKIs) that block the growth of new blood vessels that feed the cancer, as well as drugs that inhibit an enzyme called mTOR that is involved in ccRCC growth and immune therapies that rev up the body’s immune response to try to fight the cancer. Each of these treatments can have significant side effects for patients that can make them difficult to tolerate.
Metastatic ccRCC is largely incurable, and we need novel and better-tolerated treatments. A central driver of ccRCC is a protein called hypoxia inducible factor 2alpha (HIF-2alpha). This protein has been very difficult to try to target with a drug. This study is the first to test a drug that targets HIF-2alpha in patients with metastatic ccRCC. The study results showed that the HIF-2alpha inhibitor, PT2385 (Peloton Therapeutics) was active in fighting metastatic ccRCC and was well-tolerated.
Normal rhythm tracing (top) Atrial fibrillation (bottom) Wikipedia[/caption]
Interview with:
Dr Xiaoxi Yao PhD
Assistant Professor
Researcher
Mayo Clinic
What is the background for this study? What are the main findings?
Response: Lifelong oral anticoagulation, either with warfarin or a non-vitamin K antagonist oral anticoagulant (NOAC), is indicated for stroke prevention in most patients with atrial fibrillation (AF). Emerging evidence suggests that NOACs may be associated with better renal outcomes than warfarin.
The study found renal function decline is common among patients with atrial fibrillation treated with oral anticoagulants. NOACs, particularly dabigatran and rivaroxaban, may be associated with lower risks of adverse renal outcomes than warfarin.
Dr. Hedayati[/caption]
Dr. Susan Hedayati MD
Yin Quan-Yuen Distinguished Professorship in Nephrology
University of Texas Southwestern
Dallas, Texas
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: We previously showed that Major Depression is associated with a significantly higher risk of death, dialysis initiation, and hospitalization among patients with Chronic Kidney Disease (CKD). Now we show that a common antidepressant medication, a selective serotonin reuptake inhibitors (SSRI), sertraline, does not improve depression in this patient population, a chronically ill group that is not only at significantly increased risk for developing depression but also its serious complications.
Vicente E. Torres, M.D., Ph.D.
Director of the Mayo Clinic Translational Polycystic Kidney Disease (PKD) Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Experimental work pioneered by Dr. Jared Grantham showed that cyclic AMP, an intracellular signaling molecule, promotes the development and growth of cysts. Vasopressin, a hormone produced by the pituitary gland, stimulates the production of cyclic AMP in the collecting ducts, from which most cysts derive in autosomal dominant polycystic kidney disease (ADPKD). While this effect of vasopressin is necessary for the kidneys to concentrate and reduce the volume of urine, it promotes the development and growth of cysts in patients with ADPKD. Dr. Vincent Gattone realized that inhibiting the action of vasopressin could be protective in polycystic kidney disease. Work in our and other laboratories confirmed that suppression of vasopressin production, release or action reduces cyst burden, protects kidney function, and prolongs survival in rodent models of the disease.
This experimental work provided a strong rationale for clinical trials of tolvaptan, a vasopressin V2 receptor antagonist. Tolvaptan reduced the rate of kidney growth in the TEMPO 3:4 trial, in patients with early ADPKD. It also reduced the rate of decline in kidney function, measured by the estimated glomerular filtration rate (eGFR), from 10.1 to 6.8 mL/min/1.73 m2 over three years. The eGFR benefit was maintained during two additional years when all the patients were treated with tolvaptan in an open label extension of the TEMPO 3:4 trial (TEMPO 4:4). Safety laboratory tests performed every four months showed elevations of liver transaminases in blood in 4.4% of tolvaptan and 1% of placebo-treated patients. Three of 1,271 tolvaptan-treated patients during TEMPO 3:4 and TEMPO 4:4 had evidence of potentially serious drug-induced liver injury. These abnormalities occurred all within the first 18 months of exposure to tolvaptan.
Based on the TEMPO 3:4 results, tolvaptan was approved for the treatment of rapidly progressive ADPKD in Japan, Canada, European Union, Switzerland and South Korea. In the United States, the Food and Drug Administration requested additional data to further evaluate the efficacy and safety of this drug. The REPRISE trial was performed to determine the efficacy and safety of tolvaptan in patients with later stage ADPKD.
Dr. Shah[/caption]
Silvi Shah, MD, FACP, FASN|
Assistant Professor
Division of Nephrology
University of Cincinnati
Cincinnati, OH
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Elderly represent the fastest growing segment of incident dialysis patients in Unites States. The annual mortality in end stage renal disease (ESRD) patients is very high ~ 20%.
Since most of the deaths occur in the first year of dialysis, it is possible that health conditions present prior to initiation of dialysis may impact long-term outcomes. In this study, we determined the impact of poor functional status at the time of dialysis initiation and pre-dialysis health status on type of dialysis modality, type of hemodialysis access and one-year mortality in elderly dialysis patients. We evaluated 49,645 adult incident dialysis patients (1/1/2008 to 12/31/2008) from the United Data Renal Data System (USRDS) with linked Medicare data for at least 2 years prior to dialysis initiation. Mean age of our study population was 72 years. At dialysis initiation, 18.7% reported poor functional status, 88.9% has pre-dialysis hospitalization, and 27.8% did not receive pre-dialysis nephrology care. Patients with poor functional status had higher odds of being initiated on hemodialysis than peritoneal dialysis, lower odds of using arteriovenous access as compared to central venous catheter for dialysis and higher risk of one-year mortality.
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