Clinical Trials Logo

Clinical Trial Summary

This multi-center, open-label Phase 2 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with the following rare chronic kidney diseases (CKD): CKD associated with type 1 diabetes (T1D), IgA nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS), and autosomal dominant polycystic kidney disease (ADPKD). Patients will be enrolled in disease specific cohorts within the trial, and effectiveness of bardoxolone methyl in treating CKD will be assessed separately by cohort for each rare CKD. All patients in the study will follow the same visit and assessment schedule. Following randomization on Day 1, patients will be scheduled to be assessed during treatment at Weeks 1, 2, 4, 6, 8, and 12, and by telephone contact on Days 3, 10, 21, 31, 38, and 45. Patients will also be scheduled to be assessed at an in-person follow-up visit at Week 16, four weeks after the end of treatment.


Clinical Trial Description

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03366337
Study type Interventional
Source Biogen
Contact
Status Completed
Phase Phase 2
Start date December 26, 2017
Completion date January 29, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT05016323 - A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy. Phase 2
Withdrawn NCT02433236 - Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy Phase 2
Recruiting NCT02231125 - Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy Phase 4
Completed NCT01502579 - An Observational Study of IgA Nephropathy: Pathological Variants and Clinical Data N/A
Not yet recruiting NCT01203007 - Diet Intervention in Food Sensitive Patients With IgA Nephropathy N/A
Terminated NCT01129557 - Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney Disease Phase 4
Completed NCT00657059 - Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN) Phase 3
Recruiting NCT04684745 - Open-Label Extension Study of BION-1301 in IgA Nephropathy Phase 2
Completed NCT03719443 - First in Human Study to Assess Safety of VIS649 in Healthy Subjects Phase 1
Withdrawn NCT02052219 - BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy Phase 3
Completed NCT02112838 - Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy Phase 2
Completed NCT00767221 - Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study Phase 2
Recruiting NCT04438603 - The Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA Nephropathy
Recruiting NCT06065852 - National Registry of Rare Kidney Diseases
Terminated NCT04905212 - A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy Phase 2
Terminated NCT04042623 - Study of Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy Phase 2
Recruiting NCT03633864 - Fecal Microbiota Transplantation for Refractory IgA Nephropathy Phase 2
Not yet recruiting NCT06454110 - Study of NM8074 in Patients With Immunoglobulin A Nephropathy (IgAN) Phase 2
Recruiting NCT02954419 - IgA Nephropathy Biomarkers Evaluation Study (INTEREST)
Recruiting NCT03001947 - IgA Nephropathy Registration Initiative of High Quality (INSIGHT)