A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Veverimer in Adults With CKD and Metabolic Acidosis (The REVIVE Study)
Renibus Therapeutics, Inc.
Summary
The purpose of this 26 week study is is to evaluate the efficacy and safety of veverimer in treating adults with moderate-to-severe chronic kidney disease (CKD) and metabolic acidosis.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Written informed consent. * ≥ 18 years old (male/female)). * CKD with eGFR \< 60 mL/min/1.73m²; not expected to need dialysis/ transplant during study. * 2 SBC values 12-21 mmol/L within 6 months pre-screening * During screening: 2 central SBC values 12-21 mmol/L * Willing to maintain stable diet . * Expect to keep oral alkali therapy dose stable. * Women of childbearing potential: negative pregnancy test and agree to abstinence or contraception. Exclusion Criteria: * Any participant deemed by the Investigator to be an inappropriate candidate for physical performance t…
Interventions
- DrugVeverimer
Group 1: 9 g veverimer BID
- DrugPlacebo
Group 2: 9 g PBO BID
Locations (16)
- California Institute of Renal ResearchChula Vista, California
- Academic Medical Research InstituteLos Angeles, California
- UC Davis Health, Dept of Internal MedicineSacramento, California
- Velocity Clinical ResearchEdgewater, Florida
- Belkis Delgado MD PAMiami Springs, Florida
- ClinTrial Research - OakwaterOrlando, Florida