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 groupsSponsors and collaborators
Source ClinicalTrials.gov