drugset / Trial / NCT03710291
Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2018-11-20
- Primary completion
- 2022-08-23
- Completion
- 2022-09-27
Outcome
Missed primary endpoint
Stopped: “Administrative reasons”
paper CONCLUSIONS: Among patients with CKD and metabolic acidosis, treatment with veverimer did not slow CKD progression. PMID 38261535 ↗
paper A primary end point event occurred in 149/741 and 148/739 patients in the veverimer and placebo groups, respectively (hazard ratio, 0.99; 95% confidence interval, 0.8 to 1.2; P = 0.90). PMID 38261535 ↗
Publications
- Tangri N, Mathur VS, Bushinsky DA, Klaerner G, Li E, Parsell D, Stasiv Y, Walker M, Wesson DE, Wheeler DC, Perkovic V, Inker LA. VALOR-CKD: A Multicenter, Randomized, Double-Blind Placebo-Controlled Trial Evaluating Veverimer in Slowing Progression of CKD in Patients with Metabolic Acidosis. J Am Soc Nephrol. 2024 Mar 1;35(3):311-320. doi: 10.1681/ASN.0000000000000292. Epub 2024 Jan 23.
- Hultin S, Johnson DW, Badve SV. Recent evidence on the effect of treatment of metabolic acid on the progression of kidney disease. Curr Opin Nephrol Hypertens. 2021 Sep 1;30(5):467-473. doi: 10.1097/MNH.0000000000000728.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Veverimer | Other / unclassified | — | Oral |