A Study to Evaluate the Efficacy and Safety of Veverimer for the Treatment of Metabolic Acidosis

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRenibus Therapeutics, Inc.

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Any participant deemed by the Investigator to be an inappropriate candidate for physical performance testing (e.g., severe musculoskeletal pain, non-ambulatory status) or with a screening STS5 time < 10 seconds (i.e., very mobile).

Any participant deemed by the Investigator to be an inappropriate candidate for CPET (e.g., advanced chronic obstructive pulmonary disease [COPD], major cardiovascular [CV] event in last 6 months, systolic blood pressure [SBP] > 200 mmHg or diastolic blood pressure [DBP] > 120 mmHg). Only applicable to sites performing CPET and if the participant will take part in CPET.

Clinically significant gastroparesis or a history of bariatric surgery.

Bowel obstruction, swallowing disorders, severe gastrointestinal disorders, including inflammatory bowel disease, major gastrointestinal surgery, or known active gastric/duodenal ulcers.

Trial design

Treatments tested in this trial

  • Veverimer
  • Placebo

Treatment groups

150 Participants
are divided into 2 treatment groups

Locations

21
California
California Institute of Renal Research91910, Chula Vista United States
Academic Medical Research Institute90022, Los Angeles United States
UC Davis Health, Dept of Internal Medicine95817, Sacramento United States
California Institute of Renal Research - San Diego92111, San Diego United States

Sponsors and collaborators

Renibus Therapeutics, Inc.

Lead sponsor