Design and population of the VALOR-CKD study: a multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of veverimer in slowing progression of chronic kidney disease in patients with metabolic acidosis

Author:

Mathur Vandana S1ORCID,Bushinsky David A2,Inker Lesley3,Klaerner Gerrit4,Li Elizabeth5,Parsell Dawn4,Perkovic Vlado6,Stasiv Yuri4,Walker Michael7,Wesson Donald E8,Wheeler David C9,Tangri Navdeep10

Affiliation:

1. MathurConsulting LLC , Woodside, CA , USA

2. University of Rochester School of Medicine , Rochester, NY , USA

3. Division of Nephrology, Tufts Medical Center , Boston, MA , USA

4. Tricida, Inc. , South San Francisco, CA , USA

5. Pharmastat LLC , Fremont, CA , USA

6. University of New South Wales , Sydney, New South Wales , Australia

7. Walker Biosciences , Carlsbad, CA , USA

8. Dell Medical School, The University of Texas at Austin, Austin, TX, USA, Donald E. Wesson Consulting, LLC , Dallas, TX , USA

9. Department of Renal Medicine, University College London , London , UK

10. Department of Internal Medicine, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba , Winnipeg, Manitoba , Canada

Abstract

ABSTRACT Background Whether treating metabolic acidosis slows progression of chronic kidney disease (CKD) has not been established. 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 metabolic acidosis with the goal of slowing progression of CKD. Methods The VALOR-CKD trial is an international, randomized, multicenter, double-blind, placebo-controlled study designed to evaluate the effect of once-daily veverimer on kidney disease progression in patients with metabolic acidosis and CKD. Eligibility criteria include a serum bicarbonate in the range of 12–20 mmol/L and an estimated glomerular filtration rate (eGFR) of 20–40 mL/min/1.73 m2. The primary outcome is kidney disease progression defined as the development of end-stage kidney disease, a sustained decline in eGFR of >40% from baseline or death due to kidney failure. Key secondary endpoints include effects on physical function. Results Between December 2018 and December 2021, 1480 participants were randomized. The mean age at baseline was 65.1 years and 42% of the patients were female. The mean baseline eGFR was 29.1 mL/min/1.73 m2 and mean serum bicarbonate was 17.5 mmol/L. The median urine albumin-to-creatinine ratio at screening was 201 mg/g and the median 5-year predicted risk of kidney failure was 32%. Diabetes and hypertension were present in 56% and 98% of participants, respectively. Conclusions VALOR-CKD has recruited a large population of people with metabolic acidosis at high risk for CKD progression to determine the effects of veverimer on the risk of progressive loss of kidney function.

Funder

Tricida, Inc.

Publisher

Oxford University Press (OUP)

Subject

Transplantation,Nephrology

Reference36 articles.

1. 2012 Clinical practice guideline for the evaluation and management of chronic kidney disease;KDIGO;Kidney Int Suppl (2011),2013

2. Influence of mortality on estimating the risk of kidney failure in people with stage 4 CKD;Ravani;J Am Soc Nephrol,2019

3. Renin-angiotensin-aldosterone system and progression of renal disease;Rüster;J Am Soc Nephrol,2006

4. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy;Perkovic;N Engl J Med,2019

5. Dapagliflozin in patients with chronic kidney disease;Heerspink;N Engl J Med,2020

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