Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis (VALOR-CKD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03710291|
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : November 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Acidosis Chronic Kidney Disease||Drug: TRC101 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects With Metabolic Acidosis|
|Actual Study Start Date :||November 20, 2018|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||November 2022|
Oral, non-absorbed, polymeric hydrochloric acid binder
Other Name: Veverimer
|Placebo Comparator: Placebo||
- Progression of chronic kidney disease. [ Time Frame: Through study completion, on average 3.5 years. ]Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death.
- Time to ESRD. [ Time Frame: Through study completion, on average 3.5 years. ]Time to either chronic dialysis or kidney transplant.
- eGFR slope. [ Time Frame: Through study completion, on average 3.5 years. ]Change in eGFR over time.
- KDQOL. [ Time Frame: Through study completion, on average 3.5 years. ]Kidney Disease Quality of Life Physical Functioning Survey.
- CKD progression or cardiovascular death [ Time Frame: Through study completion, on average 3.5 years. ]Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death; or cardiovascular death.
- All-cause hospitalization. [ Time Frame: Through study completion, on average 3.5 years. ]Hospitalization or >24 hours emergency department stay.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03710291
|Contact: Yuri Stasiv, PhDemail@example.com|
Show 316 Study Locations