Who is sponsoring NCT01053936?

NCT01053936 is sponsored by Biogen.

What drugs are being tested in NCT01053936?

Interventions in NCT01053936: Bardoxolone methyl (amorphous dispersion).

What condition does NCT01053936 study?

NCT01053936 studies Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2.

Is NCT01053936 still recruiting?

NCT01053936 is currently completed. Last updated 29 May 2025.

Last reviewed 2025-05-29 · How we verify

NCT01053936

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

Phase II Pharmacodynamic Trial to Determine the Effects of Bardoxolone Methyl on eGFR in Patients With Type 2 Diabetes and Chronic Kidney Disease

Completed Phase 2 Last updated 29 May 2025

What this trial tests

Phase 2 trial testing Bardoxolone methyl (amorphous dispersion) in Renal Insufficiency, Chronic in 129 participants. Completed in 28 February 2011.

Timeline

31 January 2010

Primary endpoint
31 December 2010

28 February 2011

Quick facts

Lead sponsor	Biogen
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	129
Start date	31 January 2010
Primary completion	31 December 2010
Estimated completion	28 February 2011
Sites	26 locations across United States

Drugs / interventions tested

Bardoxolone methyl (amorphous dispersion) — full drug profile →

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

18 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 study assesses the effects of a new formulation of bardoxolone methyl on eGFR in Patients with Chronic Kidney Disease and Type 2 Diabetes.

Publications & conference data

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

Targeting oxidative stress in disease: promise and limitations of antioxidant therapy.
Forman HJ, Zhang H. · · 2021 · cited 1789× · PMID 34194012 · DOI 10.1038/s41573-021-00233-1
Activators and Inhibitors of NRF2: A Review of Their Potential for Clinical Development.
Robledinos-Antón N, Fernández-Ginés R, Manda G, Cuadrado A. · · 2019 · cited 443× · PMID 31396308 · DOI 10.1155/2019/9372182
Bardoxolone methyl (CDDO-Me) as a therapeutic agent: an update on its pharmacokinetic and pharmacodynamic properties.
Wang YY, Yang YX, Zhe H, He ZX, et al · · 2014 · cited 187× · PMID 25364233 · DOI 10.2147/dddt.s68872
Can Activation of NRF2 Be a Strategy against COVID-19?
Cuadrado A, Pajares M, Benito C, Jiménez-Villegas J, et al · · 2020 · cited 168× · PMID 32711925 · DOI 10.1016/j.tips.2020.07.003
Nrf2: The Master and Captain of Beta Cell Fate.
Baumel-Alterzon S, Katz LS, Brill G, Garcia-Ocaña A, et al · · 2021 · cited 81× · PMID 33243626 · DOI 10.1016/j.tem.2020.11.002
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
Recent Advances in Understanding Nrf2 Agonism and Its Potential Clinical Application to Metabolic and Inflammatory Diseases.
Kim MJ, Jeon JH. · · 2022 · cited 60× · PMID 35269986 · DOI 10.3390/ijms23052846
Synthetic oleanane triterpenoids enhance blood brain barrier integrity and improve survival in experimental cerebral malaria.
Crowley VM, Ayi K, Lu Z, Liby KT, et al · · 2017 · cited 19× · PMID 29137631 · DOI 10.1186/s12936-017-2109-0

Verify or expand the search:

Other recruiting trials for Renal Insufficiency, Chronic

Currently open trials in the same condition.

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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 NCT01053936 (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/NCT01053936.

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