Overview
Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis
Status:
Recruiting
Recruiting
Trial end date:
2024-12-01
2024-12-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Tricida, Inc.
Criteria
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.