An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)

  • STATUS
    Recruiting
  • End date
    Dec 26, 2025
  • participants needed
    480
  • sponsor
    Reata Pharmaceuticals, Inc.
Updated on 26 January 2021
renal failure
nephropathy
chronic kidney disease
renal disease

Summary

This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with chronic kidney disease (CKD) who previously participated in one of the qualifying clinical studies with bardoxolone methyl. Patients will remain in the study until bardoxolone methyl is available through commercial channels or until patient withdrawal, whichever is sooner.

Details
Condition Renal Failure, Polycystic Kidney, Autosomal Dominant, Collagen disease, Alport's Syndrome, Nephritis, Collagen Vascular Diseases, Chronic Kidney Diseases, Kidney Failure (Pediatric), Kidney Failure, autosomal dominant polycystic kidney disease, chronic kidney disease, chronic kidney disease (ckd)
Treatment Bardoxolone methyl
Clinical Study IdentifierNCT03749447
SponsorReata Pharmaceuticals, Inc.
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 12 yrs?
Gender: Male or Female
Do you have any of these conditions: Alport's Syndrome or Chronic Kidney Diseases or Polycystic Kidney, Autosomal Dominant or Renal Failure or Kidney Failure (Pediatric) or Collagen disea...?
Do you have any of these conditions: autosomal dominant polycystic kidney disease or Nephritis or Kidney Failure or Alport's Syndrome or Collagen Vascular Diseases or Chronic Kidney Disea...?
Do you have any of these conditions: Nephritis or chronic kidney disease or Collagen disease or autosomal dominant polycystic kidney disease or Collagen Vascular Diseases or chronic kidne...?
Do you have any of these conditions: Chronic Kidney Diseases or Renal Failure or autosomal dominant polycystic kidney disease or chronic kidney disease or chronic kidney disease (ckd) or ...?
Patients who are participating (or who have participated) in qualifying studies and who have not been required to discontinue study treatment for protocol or safety reasons and who have completed required End-of-Treatment and/or Follow-up visits in a prior clinical study with bardoxolone methyl and who, according to the assessment of the investigator, have a potential positive benefit-risk assessment for participating in the trial
Meets the following eligibility criteria based on assessments from the prior qualifying study (last on-treatment visit) or from a screening visit, if applicable
Not expected to reach end stage kidney disease (ESKD) or nephrotic syndrome within 12 weeks of study enrollment, in the investigator's judgement; subjects with eGFR <20 ml/min/1.73m2 should be discussed with the medical monitor before enrollment (e.g., such subjects with an average rate of eGFR decline > 1.0 ml/min/1.73m2 per month in the 3 months prior to eligibility assessment may not be eligible)
BNP < 200 pg/mL at the last on-treatment visit in the prior qualifying study or at a new screening visit, if applicable
No occurrence of a cardiovascular serious adverse event in the prior qualifying study or in the interval between the end of the qualifying study and the screening visit, if applicable
Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Evidence of a personally signed and dated informed consent document (and assent form if necessary) indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study prior to initiation of any protocol-mandated procedures

Exclusion Criteria

Participation in other investigational clinical studies involving interventional products being tested or used in a way different from the approved form or when used for an unapproved indication
Patients who have an ongoing SAE from a clinical study that is assessed by the investigator as related to bardoxolone methyl
Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) while screening, taking study drug and 30 days after the last study drug dose
Women who are pregnant or breastfeeding
Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason
Known hypersensitivity to any component of the study drug
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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