NCT01655186 is a Phase 2 clinical trial of Bardoxolone Methyl in Renal Insufficiency, Chronic, sponsored by Biogen.

Who is sponsoring NCT01655186?

NCT01655186 is sponsored by Biogen.

What drugs are being tested in NCT01655186?

Interventions in NCT01655186: Bardoxolone Methyl, Placebo.

What condition does NCT01655186 study?

NCT01655186 studies Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2.

Is NCT01655186 still recruiting?

NCT01655186 is currently withdrawn. Last updated 29 May 2025.

Last reviewed 2025-05-29 · How we verify

NCT01655186

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 Study Evaluating the Effects of Bardoxolone Methyl on Body Composition in Patients With Stage 4 Chronic Kidney Disease and Type 2 Diabetes Mellitus

Withdrawn Phase 2 Last updated 29 May 2025

What this trial tests

Phase 2 trial testing Bardoxolone Methyl in Renal Insufficiency, Chronic. Withdrawn.

Timeline

30 September 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Status	Withdrawn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	30 September 2012
Primary completion	31 October 2012
Estimated completion	31 October 2012

Drugs / interventions tested

Bardoxolone Methyl — full drug profile →
Placebo

Conditions studied

Renal Insufficiency, Chronic — all drugs for Renal Insufficiency, Chronic →
Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Biogen — full company profile →

Who can join

30 and older, any sex, with Renal Insufficiency, Chronic or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This multicenter, randomized, double-blind, placebo-controlled Phase 2 safety study will assess the effect of bardoxolone methyl relative to placebo on body weight and fat mass in approximately 60 patients with stage 4 Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM).

Publications & conference data

2 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
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 trials of Bardoxolone Methyl

Trials testing the same drug.

NCT04494646 — BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19) · Phase 2 · completed
NCT03019185 — A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL · Phase 2, PHASE3 · completed
NCT01549769 — Pharmacokinetic and Pharmacodynamic Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabe · Phase 1 · terminated
NCT01563562 — Single-Dose, Open-Label Pharmacokinetic Study of Bardoxolone Methyl in Subjects With Mild, Moderate, and Severe Hepatic · Phase 1 · completed
NCT01551446 — Pilot Assessment of the Effects of Bardoxolone Methyl on Renal Perfusion, Systemic Haemodynamics and Cardiac Function in · Phase 1 · withdrawn

Other recruiting trials for Renal Insufficiency, Chronic

Currently open trials in the same condition.

NCT07522944 — AI-Guided Relaxation for Hemodialysis Anxiety · NA · recruiting
NCT07447375 — Exercise During Hemodialysis: Impact on Sarcopenia and Sleep Quality · NA · recruiting
NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · recruiting
NCT07292311 — Reliability of Muscle Strength and Activation Assessment Tools and Effects of an Online Therapeutic Exercise Program in · NA · active not recruiting
NCT06863194 — Probiotic Supplementation and Disease Progression in CKD: A Randomized Trial · Phase 1, PHASE2 · 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 NCT01655186 (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/NCT01655186.

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