Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis

  • STATUS
    Recruiting
  • End date
    Dec 13, 2024
  • participants needed
    1600
  • sponsor
    Tricida, Inc.
Updated on 13 April 2021
ace inhibitor
glomerular filtration rate
nephropathy

Summary

The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.

Description

This is a randomized, double-blind, placebo-controlled trial. Eligible subjects will be randomized in a 1:1 ratio to TRC101 or placebo. The primary endpoint of the study will be progression of renal disease, defined by time to first occurrence of any event in the composite endpoint consisting of a confirmed 40% reduction in eGFR, end-stage renal disease (ESRD), and renal death. The study will terminate when the independent blinded Clinical Endpoint Adjudication Committee has positively adjudicated the targeted number of primary efficacy endpoint events. The maximum duration of follow-up for a randomized subject is anticipated to be approximately 6 years.

Details
Condition chronic renal insufficiency, Chronic renal failure, Acidosis, chronic kidney disease, chronic kidney disease (ckd), metabolic acidosis
Treatment Placebo, TRC101
Clinical Study IdentifierNCT03710291
SponsorTricida, Inc.
Last Modified on13 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Estimated glomerular filtration rate (eGFR) 20 - 40 mL/min/1.73m^2
Serum bicarbonate 12 - 20 mEq/L
On maximum tolerated dose of ACE inhibitor and/or ARB

Exclusion Criteria

Acute metabolic acidosis
Anticipated dialysis or kidney transplant within 6 months
Recent acute kidney injury
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