ADPKD Clinical Trial
Official title:
A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Autosomal Dominant Polycystic Kidney Disease
This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD. Approximately 850 patients will be enrolled.
This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD. Patients will be randomized 1:1 to either bardoxolone methyl or placebo. Patients receiving bardoxolone methyl will start with once-daily dosing at 5 mg and will dose-escalate to 10 mg at Week 2, to 20 mg at Week 4, and then to 30 mg at Week 6 (only if baseline ACR >300 mg/g) unless contraindicated clinically and approved by the medical monitor. Dose de-escalation is permitted during the study if indicated clinically, and subsequent dose re-escalation is also permitted to meet the dosing objective of the highest tolerated dose. All patients in the study will follow the same visit and assessment schedule. Patients will continue to receive study drug or placebo through Week 100 and will not receive study drug or placebo during a 12-week off-treatment period between Weeks 100 and 112. Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04310319 -
Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and Salt
|
N/A | |
Completed |
NCT02776241 -
Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney Disease
|
N/A | |
Terminated |
NCT04152837 -
Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease
|
Phase 3 | |
Completed |
NCT03717883 -
ADPKD Alterations in Hepatic Transporter Function
|
||
Recruiting |
NCT05014178 -
Kidney Sodium Functional Imaging
|
||
Recruiting |
NCT05521191 -
A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease
|
Phase 1 | |
Terminated |
NCT04064346 -
Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease
|
Phase 3 | |
Completed |
NCT03203642 -
Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD
|
Phase 2 | |
Recruiting |
NCT04338048 -
Autosomal Dominant Polycystic Kidney Disease (ADPKD) Study
|
||
Not yet recruiting |
NCT06100133 -
Treat Autosomal Dominant Polycystic Kidney Disease With Oral Ketone Ester?
|
Phase 2 | |
Completed |
NCT01632605 -
The Vienna RAP Pilot Study
|
N/A | |
Recruiting |
NCT06416761 -
Genetics in the Progression of Nephropathies
|
||
Not yet recruiting |
NCT05373264 -
HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life
|
Phase 3 | |
Recruiting |
NCT06085807 -
Genetic Testing in Autosomal Dominant Polycystic Kidney Disease
|
||
Completed |
NCT01853553 -
Mineralocorticoid Antagonism and Endothelial Dysfunction in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
|
Phase 3 | |
Completed |
NCT04472624 -
Short Term Induction of Ketosis in PKD
|
N/A | |
Not yet recruiting |
NCT03764605 -
Metformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney Disease
|
Phase 3 | |
Completed |
NCT04680780 -
Ketogenic Dietary Interventions in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
|
N/A | |
Completed |
NCT02161068 -
Clinical Care of Autosomal Polycystic Kidney Disease: Retrospective Analysis and Prospective PKD Genotyping
|
||
Active, not recruiting |
NCT03273413 -
Statin Therapy in Patients With Early Stage ADPKD
|
Phase 4 |