NCT01576887 is a Phase 2 clinical trial of Bardoxolone Methyl 20 mg in End-Stage Renal Disease, sponsored by Biogen.

Who is sponsoring NCT01576887?

NCT01576887 is sponsored by Biogen.

What drugs are being tested in NCT01576887?

Interventions in NCT01576887: Bardoxolone Methyl 20 mg, Placebo.

What condition does NCT01576887 study?

NCT01576887 studies End-Stage Renal Disease, Type 2 Diabetes Mellitus.

Is NCT01576887 still recruiting?

NCT01576887 is currently withdrawn. Last updated 29 May 2025.

Last reviewed 2025-05-29 · How we verify

NCT01576887

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Double-Blind, Randomized, Placebo-Controlled Safety Study Evaluating the Effects of Residual Renal Function (RFF) in Patients With End-Stage Renal Disease and Type 2 Diabetes Mellitus on Peritoneal Dialysis

Withdrawn Phase 2 Last updated 29 May 2025

What this trial tests

Phase 2 trial testing Bardoxolone Methyl 20 mg in End-Stage Renal Disease. Withdrawn.

Timeline

31 July 2012

Primary endpoint
31 October 2012

31 October 2012

Quick facts

Lead sponsor	Biogen
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Start date	31 July 2012
Primary completion	31 October 2012
Estimated completion	31 October 2012

Drugs / interventions tested

Bardoxolone Methyl 20 mg
Placebo

Conditions studied

End-Stage Renal Disease — all drugs for End-Stage Renal Disease →
Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

Biogen — full company profile →

Who can join

18 and older, any sex, with End-Stage Renal Disease or Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a multi-center, double-blinded, randomized, study of bardoxolone methyl treatment in patients with End-Stage Renal Disease (ERSD) and Type 2 Diabetes Mellitus (T2DM) on peritoneal dialysis.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Protective Role of Nrf2 in Renal Disease.
Guerrero-Hue M, Rayego-Mateos S, Vázquez-Carballo C, Palomino-Antolín A, et al · · 2020 · cited 74× · PMID 33396350 · DOI 10.3390/antiox10010039
Health position paper and redox perspectives - Bench to bedside transition for pharmacological regulation of NRF2 in noncommunicable diseases.
Cuadrado A, Cazalla E, Bach A, Bathish B, et al · · 2025 · cited 9× · PMID 40059038 · DOI 10.1016/j.redox.2025.103569
Induction of Cardiac Pathology: Endogenous versus Exogenous Nrf2 Upregulation.
Mathis BJ, Kato H, Hiramatsu Y. · · 2022 · cited 5× · PMID 36497112 · DOI 10.3390/cells11233855

Verify or expand the search:

Other recruiting trials for End-Stage Renal Disease

Currently open trials in the same condition.

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NCT05931276 — CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes · Phase 3 · recruiting

Other Biogen trials

Trials by the same sponsor.

NCT07483632 — A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses · Phase 3 · not yet recruiting
NCT06628687 — A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it Duri · recruiting
NCT07444450 — A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy · Phase 3 · not yet recruiting
NCT07444489 — A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants · Phase 3 · not yet recruiting
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

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01576887 (US National Library of Medicine, public domain)
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: 29 May 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/NCT01576887.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing