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High-impact Clinical Trials Yield Results That Could Improve Kidney Care

 

Medicine, Health Care High-impact Clinical Trials Yield Results…

Published: November 6, 2017.
Released by American Society of Nephrology  

New Orleans, LA (November 3, 2017) — The results of numerous high-impact clinical trials that could affect kidney-related medical care will be presented at ASN Kidney Week 2017, October 31-November 5 at the Ernest N. Morial Convention Center in New Orleans, LA.

* In the phase 3, multi-center, randomized withdrawal, placebo controlled, double-blind REPRISE trial, tolvaptan–a drug used to treat low blood sodium–slowed kidney function decline (as measured by eGFR) by 35% over 1-year in individuals with later-stage autosomal dominant polycystic kidney disease (ADPKD). In the study of 1370 ADPKD patients, annualized eGFR change from pre-treatment baseline to post-treatment follow-up was -2.34 mL/min/1.73 m2 with tolvaptan versus -3.61 mL/min/1.73 m2 with placebo. “In the REPRISE trial, in patients with ADPKD and declining renal function, tolvaptan slowed the rate of decline. This, in addition to data from other trials with tolvaptan for ADPKD, means that it may delay the need for a kidney transplant or dialysis, and represents a significant milestone in the investigation of a condition for which there are currently no approved treatments,” said Vincente Torres, MD, PhD, lead author of the study. “Other drugs currently studied in many laboratories and medical centers, in combination with tolvaptan or by themselves, may in the future further improve the outlook of patients with this disease.

Tolvaptan Slows eGFR Decline in Later-Stage ADPKD

* In a randomized, double-blind, placebo-controlled, multi-center Phase 2 trial of 120 patients with diabetic kidney disease, a significant improvement in kidney function (as assessed using an inulin clearance method) was seen in patients who received bardoxolone–a drug that activates a transcription factor involved in antioxidant and anti-inflammatory responses–compared with those who received placebo (6.6 ml/min/1.73 m2). Bardoxolone was well tolerated, and no signs or symptoms of fluid overload were observed. “Based on the results of our study, bardoxolone methyl clearly improves renal function. Among preselected patients, bardoxolone methyl may yield significant treatment benefits without safety concerns,” said Masaomi Nangaku, MD, PhD, lead author of the study. “We would like to verify the efficacy and safety of bardoxolone methyl in the next Phase 3 trial with large numbers of patients.

Bardoxolone Methyl Improved GFR Measured by Standard Inulin Clearance: The TSUBAKI Study

* In a study of patients with suspected coronary artery disease who were randomly assigned to invasive coronary angiography (ICA) with intracoronary contrast or coronary computed tomography angiography (CTA) with intravenous contrast, contrast-induced acute kidney injury occurred in 6% of patients in the CTA group and 13% of patients in the ICA group. In blood tests done after a median duration of 1.9 years, a greater proportion of patients with acute kidney injury still had increased creatinine, a sign of kidney injury, compared with those without acute kidney injury (38% vs. 6%). “X-ray contrast agents can have toxic effects on the kidney. We do not know whether this is more likely if the contrast agents are injected into veins for cardiac CT or directly into the heart for cardiac catheterization,” said lead author Marc Dewey, MD. “This randomized study shows that acute kidney injury is less likely after cardiac CT than after cardiac catheterization and that such contrast-induced acute kidney injury is associated with impaired chronic kidney function after a median 1.9 years of follow-up.”

Kidney Injury after Intravenous or Intracoronary Contrast Agents for Non-Invasive or Invasive Coronary Angiography: An Industry-Independent, Phase 3, Randomized Controlled Trial

* Acute kidney injury (AKI), an abrupt decline in kidney function, often arises after major surgeries. No treatments are approved for the prevention of AKI following cardiac surgery, but in a large, randomized, double-blind, placebo-controlled Phase 2 trial, a small inhibitory RNA (called QPI-1002) reduced the incidence, grade, and duration of AKI in high-risk patients. In the study of 341 cardiac surgery patients, 37% who were treated with QPI developed AKI vs. 50% of those treated with placebo. QPI targets p53, a protein that promotes cell death “QPI-1002 is an experimental RNA interfering medication that reduces kidney cell death and allows the injured kidney cells to repair and recover,” said co-author Shai Erlich, PhD.  “These promising results support conducting a larger Phase 3 trial toward bringing a new drug to help patients with this unmet medical need.”

Efficacy and Safety of QPI-1002 (QPI) For Prevention of Acute Kidney Injury (AKI) Following Cardiac Surgery (CS)

* For accessing patients’ blood during hemodialysis, most experts recommend an arteriovenous fistula, which is created by connecting the patient’s own vein and artery to form a long-lasting site through which blood can be removed and returned. An arteriovenous fistula is usually created by a surgical procedure, but percutaneous creation of an arteriovenous fistula with a thermal resistance anastomosis device (TRAD) in an office-based vascular center is emerging as an alternative to surgery. A trial of 107 patients found that the procedure is safe and effective. “Americans with failing kidneys may soon be able to get the preferred arteriovenous fistula for hemodialysis without surgery,” said lead author Jeffrey Hull, MD. “The minimally invasive procedure can be performed in the office without going to the hospital. The ease and convenience of the procedure should improve the patient experience and improve the quality of care for patients with end stage renal disease.”

The Pivotal Multicenter Trial of Ultrasound Guided Percutaneous Arteriovenous Fistulae for Hemodialysis Access

* In the Time to Reduce Mortality in End-Stage Renal Disease (TiME) trial, investigators looked to see if patients with kidney failure benefit more from longer vs. shorter times on hemodialysis. TiME was a new type of research called a “pragmatic trial” in which much larger than usual numbers of patients take part in research as part of their regular healthcare, thus making the research results more consistent with the real-world lives of patients and physicians, and making the research more affordable. Although TiME was not able to answer the primary research question, the trial enrolled and collected data on more than 7000 patients in a highly efficient manner and demonstrated that a partnership between physician-researchers at medical schools and private dialysis companies can conduct pragmatic trials to address major issues facing patients with kidney failure. “The lessons and successes of TiME will provide important guidance for the next generation of clinical trials in medicine,” said lead author Laura Dember, MD.

Primary Results of the Time to Reduce Mortality in End-Stage Renal Disease (TiME) Trial: A Pragmatic Trial Demonstration Project of the NIH Health Care Systems Research Collaboratory

* A new multi-center randomized controlled trial has evaluated the efficacy of 2 immunosuppression medications, cyclosporine and rituximab, in inducing remission of proteinuria in patients with membranous nephropathy. It also evaluated how these 2 medications performed in keeping patients in remission once remission of proteinuria was achieved, and how the treatments affected patients’ quality of life. Preliminary findings from the trial–called MENTOR–will be presented at ASN Kidney Week.

A Multi-Center Randomized Controlled Trial of Rituximab versus Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy (MENTOR)

* Bruce D. Greenstein, U.S. Department of Health and Human Services, Chief Technology Officer, will announce HHS’ intent to launch a Kidney Innovation Accelerator which will establish a public-private innovation fund capable of seeding and accelerating not just incremental improvements in treating kidney disease, but will foster real breakthroughs in dialysis and other treatments for kidney disease. Accelerating New Possibilities in Kidney Disease *Please note, the embargo for this lifts at 11:00 a.m. (CT) on November 3.

ASN Kidney Week 2017, the largest nephrology meeting of its kind, will provide a forum for more than 13,000 professionals to discuss the latest findings in kidney health research and engage in educational sessions related to advances in the care of patients with kidney and related disorders. Kidney Week 2017 will take place October 31-November 5, 2017 in New Orleans, LA.

Since 1966, the American Society of Nephrology (ASN) has been leading the fight to prevent, treat, and cure kidney diseases throughout the world by educating health professionals and scientists, advancing research and innovation, communicating new knowledge, and advocating for the highest quality care for patients. ASN has nearly 17,000 members representing 112 countries. For more information, please visit http://www.asn-online.org or contact us at 202-640-4660.


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