Kidney Week

Abstract: FR-OR65

VALOR-CKD: A Multicenter, Randomized, Double-Blind Placebo-Controlled Trial Evaluating Veverimer in Slowing Progression of CKD in Patients With Metabolic Acidosis

Session Information

• High-Impact Clinical Trials
  November 04, 2022 | Location: W415 Valencia, Orange County Convention Center‚ West Building
  Abstract Time: 11:30 AM - 11:45 AM

Category: CKD (Non-Dialysis)

• 2202 CKD (Non-Dialysis): Clinical‚ Outcomes‚ and Trials

Authors

• Tangri, Navdeep, University of Manitoba, Winnipeg, Manitoba, Canada

Navdeep Tangri,

• Mathur, Vandana S., MathurConsulting LLC, Woodside, California, United States

Vandana S. Mathur,

• Bushinsky, David A., University of Rochester Medical Center, Rochester, New York, United States

David A. Bushinsky,

• Inker, Lesley Ann, Tufts Medical Center, Boston, Massachusetts, United States

Lesley Ann Inker,

• Klaerner, Gerrit, Tricida Inc., South San Francisco, California, United States

Gerrit Klaerner,

• Li, Elizabeth, Pharmastat LLC, Fremont, California, United States

Elizabeth Li,

• Parsell, Dawn, Tricida Inc., South San Francisco, California, United States

Dawn Parsell,

• Stasiv, Yuri, Tricida Inc., South San Francisco, California, United States

Yuri Stasiv,

• Walker, Michael, University of California San Diego, La Jolla, California, United States

Michael Walker,

• Wesson, Donald E., The University of Texas at Austin, Austin, Texas, United States

Donald E. Wesson,

• Wheeler, David C., University College London, London, London, United Kingdom

David C. Wheeler,

• Perkovic, Vlado, University of New South Wales, Sydney, New South Wales, Australia

Vlado Perkovic,

Background

Veverimer is a novel hydrochloric acid binder that removes acid from the gastrointestinal tract leading to an increase in serum bicarbonate. It is being developed to treat chronic metabolic acidosis and this trial was designed to assess whether it would slow progression of chronic kidney disease (CKD).

Methods

VALOR-CKD trial is an international, Phase 3, randomized, multicenter, double-blind, placebo-controlled study evaluating the effect of once-daily veverimer on kidney disease progression in patients with CKD and chronic metabolic acidosis. Eligible participants had CKD (estimated glomerular filtration rate [eGFR] of 20-40 mL/min/1.73 m²) and a serum bicarbonate of 12-20 mEq/L. The primary outcome was the composite endpoint of kidney disease progression, defined as the development of end-stage kidney disease (kidney transplantation or maintenance dialysis), a sustained decline in eGFR of >40% from baseline, or death due to kidney failure. Key secondary endpoints included effects on physical function, cardiovascular death, and all-cause death. Components of the primary endpoint and deaths were adjudicated by an independent, blinded, clinical endpoint adjudication committee.

Results

We screened 5,254 patients and randomized (1:1) 1,480 from 34 countries and 191 sites. The mean (±standard deviation) age at baseline was 65.1±12.5 years with 42% female. The mean baseline eGFR was 29.1±6.3 mL/min/1.73 m² and mean serum bicarbonate was 17.5±1.4 mEq/L. The median (interquartile range) urine albumin-to-creatinine ratio was 168 (707) mg/g and the median 5-year predicted risk of kidney failure was 24%. More than 98% of patients were on an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker and ~12% were on background alkali supplements. At baseline, 56%, 98%, and 32% of patients had a history of diabetes, hypertension, and heart failure, respectively.

Topline data and results for the VALOR-CKD trial will be available in October 2022.

Conclusion

VALOR-CKD will test the efficacy of veverimer to slow CKD progression and preserve physical function, along with safety, in patients with CKD and chronic metabolic acidosis.

Funding

• Commercial Support – Tricida, Inc.