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



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 85
Updated:3/22/2019
Start Date:November 20, 2018
End Date:November 2022
Contact:Yuri Stasiv, PhD
Email:ystasiv@tricida.com
Phone:415-988-5120

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A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects With Metabolic Acidosis

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.

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.
We found this trial at
26
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Coral Springs, Florida 33067
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Augusta, Georgia 30904
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Azusa, California 91702
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Bethlehem, Pennsylvania 18017
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Bradenton, Florida 34201
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Charlotte, North Carolina 28210
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Chattanooga, Tennessee 37408
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Greenbelt, Maryland 20770
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Greenville, North Carolina 27834
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Greer, South Carolina 29651
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Hollywood, Florida 33021
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Katy, Texas 77494
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Kinston, North Carolina 28504
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Knoxville, Tennessee 37923
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Las Vegas, Nevada 89119
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Lauderdale Lakes, Florida 33313
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Liège,
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Mesa, Arizona 85210
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Miami, Florida 33145
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Miami Gardens, Florida 33169
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Miami Lakes, Florida 33014
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New Bern, North Carolina 28562
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Orangeburg, South Carolina 29118
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Port Charlotte, Florida 33952
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Sacramento, California 95825
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Sugar Land, Texas 77478
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Sugar Land, TX
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