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

Phase 3

Terminated

• Conditions: Chronic Kidney Disease; Metabolic Acidosis
• Interventions: Drug: Placebo; Drug: TRC101

• Registration Number: NCT03710291
• Lead Sponsor: Tricida, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-15
• Study First Posted: 2018-10-18
• Study Start: 2018-11-20
• Primary Completion: 2022-08-23
• Study Completion: 2022-09-27
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1480

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
TRC101	TRC101	-

Primary Outcome Measures

Name	Time	Method
Progression of chronic kidney disease	Through study completion, up to approximately 6 years.	Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death.

Secondary Outcome Measures

Name	Time	Method
Death (all-cause), ESRD or a confirmed ≥50% reduction in eGFR	Through study completion, up to approximately 6 years.	Time to first occurrence of: death (all-cause); ESRD; a confirmed ≥50% reduction in eGFR.
Cardiovascular death	Through study completion, up to approximately 6 years.	Time to cardiovascular death.
≥40% reduction in eGFR	Through study completion, up to approximately 6 years.	Time to first occurrence of a confirmed ≥40% reduction in eGFR.
Serum creatinine	Through study completion, up to approximately 6 years.	Time to first occurrence of a confirmed doubling of serum creatinine.
≥50% reduction in eGFR	Through study completion, up to approximately 6 years.	Time to first occurrence of a confirmed ≥50% reduction in eGFR.
Physical functioning (objective)	18 months after randomization.	Repeated chair stand test.
ESRD or renal death	Through study completion, up to approximately 6 years.	Time to ESRD or renal death.
Primary outcome measure OR cardiovascular death	Through study completion, up to approximately 6 years.	Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death; cardiovascular death.
Physical functioning (subjective)	18 months after randomization.	Kidney Disease Quality of Life Physical Functioning Survey.
All-cause hospitalization	Through study completion, up to approximately 6 years.	Frequency of all-cause hospitalization.
All-cause mortality	Through study completion, up to approximately 6 years.	Time to all-cause mortality.

Trial Locations

Locations (203)

Investigative Site 4136; 🇺🇸 Azusa, California, United States

Investigative Site 4148; 🇺🇸 Denver, Colorado, United States

Investigative Site 4157; 🇺🇸 Boca Raton, Florida, United States

Investigative Site 4146; 🇺🇸 Bradenton, Florida, United States

Investigative Site 4102; 🇺🇸 Coral Springs, Florida, United States

Investigative Site 4153; 🇺🇸 Fort Lauderdale, Florida, United States

Investigative Site 4122; 🇺🇸 Hollywood, Florida, United States

Investigative Site 4123; 🇺🇸 Hollywood, Florida, United States

Investigative Site 4130; 🇺🇸 Miami Lakes, Florida, United States

Investigative Site 4104; 🇺🇸 Miami, Florida, United States

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