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Clinical trials for Bardoxolone

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    8 result(s) found for: Bardoxolone. Displaying page 1 of 1.
    EudraCT Number: 2016-004365-16 Sponsor Protocol Number: 402-C-1602 Start Date*: 2017-06-09
    Sponsor Name:Reata Pharmaceuticals, Inc.
    Full Title: An extended Access Program to Assess Long-Term Safety of Bardoxolone Methyl in Patients with Pulmonary Hypertension
    Medical condition: Pulmonary Hypertension
    Disease: Version SOC Term Classification Code Term Level
    19.1 10038738 - Respiratory, thoracic and mediastinal disorders 10037400 Pulmonary hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) BE (Completed) CZ (Completed) GB (Prematurely Ended) DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-004395-22 Sponsor Protocol Number: 402-C-1603 Start Date*: 2017-12-19
    Sponsor Name:Reata Pharmaceuticals, Inc.
    Full Title: A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome
    Medical condition: Alport Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10001843 Alport's syndrome PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2018-003253-24 Sponsor Protocol Number: 402-C-1803 Start Date*: 2020-03-04
    Sponsor Name:Reata Pharmaceuticals, Inc.
    Full Title: An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients with Chronic Kidney Disease
    Medical condition: Chronic kidney disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10064848 Chronic kidney disease PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) FR (Completed) BE (Completed) DE (Prematurely Ended) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2018-004651-20 Sponsor Protocol Number: 402-C-1808 Start Date*: 2020-02-13
    Sponsor Name:Reata Pharmaceuticals, Inc.
    Full Title: A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease
    Medical condition: Autosomal dominant polycystic kidney disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10036046 Polycystic kidney, autosomal dominant LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) FR (Prematurely Ended) CZ (Completed) BE (Completed) ES (Prematurely Ended) IT (Prematurely Ended) HU (Prematurely Ended) DK (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-000196-24 Sponsor Protocol Number: 402-C-1504 Start Date*: 2016-07-04
    Sponsor Name:Reata Pharmaceuticals, Inc.
    Full Title: A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION
    Medical condition: Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Prematurely Ended) BE (Completed) NL (Prematurely Ended) CZ (Prematurely Ended) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-004793-17 Sponsor Protocol Number: 402-C-1302 Start Date*: 2017-05-03
    Sponsor Name:Reata Pharmaceuticals, Inc.
    Full Title: A Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Pulmonary Hypertension
    Medical condition: Pulmonary Hypertension
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10037401 Pulmonary hypertensions HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Prematurely Ended) ES (Completed)
    Trial results: View results
    EudraCT Number: 2012-001563-78 Sponsor Protocol Number: 402-C-1201 Start Date*: 2012-07-03
    Sponsor Name:Reata UK Limited
    Full Title: A Double-Blind, Randomized, Placebo-Controlled Safety Study Evaluating the Effects of Bardoxolone Methyl on Residual Renal Function (RRF) in Patients with End-Stage Renal Disease (ESRD) and Type 2 ...
    Medical condition: Chronic Kidney Disease in patients with type 2 diabetes mellitus on peritoneal dialysis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038359 - Renal and urinary disorders 10038359 Renal and urinary disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-022297-14 Sponsor Protocol Number: 402-C-0903 Start Date*: 2011-10-27
    Sponsor Name:Reata Pharmaceuticals, Inc
    Full Title: Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes: The Occurence of Renal Events (BEACON)
    Medical condition: Chronic Kidney Disease Stage 4
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038359 - Renal and urinary disorders 10038359 Renal and urinary disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) AT (Prematurely Ended) ES (Prematurely Ended) CZ (Prematurely Ended) DE (Prematurely Ended) SE (Prematurely Ended) GB (Prematurely Ended) IT (Prematurely Ended)
    Trial results: (No results available)
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    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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