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

  • STATUS
    Recruiting
  • End date
    Nov 17, 2022
  • participants needed
    1600
  • sponsor
    Tricida, Inc.
Updated on 17 September 2020
Investigator
Clinical Operations
Primary Contact
Investigative Site 4141 (4.3 mi away) Contact
+481 other location
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 average duration of follow-up is anticipated to be 3.5 years.

Details
Treatment Placebo, TRC101
Clinical Study IdentifierNCT03710291
SponsorTricida, Inc.
Last Modified on17 September 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 85 yrs?
Gender: Male or Female
Do you have any of these conditions: Chronic renal failure or Acidosis or chronic renal insufficiency?
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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