Adults 18 to 65, any sex, with IgA Nephropathy or CKD Associated With Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12Primary· 12 weeks after participant receives the first dose
To assess the change in eGFR from baseline to week 12. eGFR is a measure of kidney function assessed through blood/serum. Higher eGFRs represent better/improved kidney function. Lower eGFRs represent poorer/decreased kidney function.
Group
Value
95% CI
Bardoxolone Methyl - ADPKD
9.31
± 1.3743
Bardoxolone Methyl - IgAN
8.00
± 1.5700
Bardoxolone Methyl - T1D
5.46
± 2.2792
Bardoxolone Methyl - FSGS
7.83
± 2.216
Adverse events — posted to ClinicalTrials.gov
Time frame: 16 weeks.
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Bardoxolone Methyl - ADPKD
Serious: 2/31 (6%)
Deaths: 0/31
Bardoxolone Methyl - IgAN
Serious: 0/26 (0%)
Deaths: 0/26
Bardoxolone Methyl - T1D
Serious: 0/28 (0%)
Deaths: 0/28
Bardoxolone Methyl - FSGS
Serious: 1/18 (6%)
Deaths: 0/18
Serious adverse events (5 terms)
Reaction
System
Bardoxolone Methyl - ADPKD
Bardoxolone Methyl - IgAN
Bardoxolone Methyl - T1D
Bardoxolone Methyl - FSGS
Cholecystitis
Hepatobiliary disorders
—
—
—
—
Histoplasmosis disseminated
Infections and infestations
—
—
—
—
Sepsis
Infections and infestations
—
—
—
—
Renal failure acute
Renal and urinary disorders
—
—
—
—
Hypertensive crisis
Vascular disorders
—
—
—
—
Other adverse events (164 terms — click to expand)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02657356 — Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST
· Phase 3
· terminated
Other recruiting trials for IgA Nephropathy
Currently open trials in the same condition.
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NCT06740526 — Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue
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· recruiting
NCT06767592 — A Study of Probiotics in IgA Nephropathy
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· recruiting
NCT05852938 — A Study of Zigakibart in Adults With IgA Nephropathy
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· active not recruiting
NCT05942625 — A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects
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· recruiting
Other Biogen trials
Trials by the same sponsor.
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NCT07444450 — A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy
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NCT07444489 — A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants
· Phase 3
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NCT07444476 — A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety in Participants Aged 15 to 60 Years Wit
· Phase 3
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biogen
Last refreshed: 3 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03366337.