Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis (VALOR-CKD)

Tricida

Status and phase: Terminated; Phase 3

Conditions: Chronic Kidney Disease; Metabolic Acidosis

Treatments: Drug: Placebo; Drug: TRC101

Study type: Interventional

Funder types: Industry

Identifiers

NCT03710291

TRCA-303

2018-001303-36 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,480 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,480 participants in 2 patient groups, including a placebo group

TRC101

Experimental group

Treatment:

Drug: TRC101

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo