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

  • End date
    Nov 17, 2022
  • participants needed
  • sponsor
    Tricida, Inc.
Updated on 17 September 2020
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Investigative Site 4141 (4.3 mi away) Contact
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ace inhibitor
glomerular filtration rate


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.


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.

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

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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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