Chronic kidney disease MedDRA version: 21.1 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Sponsors
Reata Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Treatment-compliant patients who are participating in qualifying ongoing studies and 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. 2. Meets the following eligibility criteria from the prior qualifying study. Patients not meeting the following criteria may be eligible if discussed with the medical monitor prior to enrollment to assess their current clinical status and written approval is obtained: a. eGFR = 30 mL/min/1.73 m^2 at the last on-treatment visit in the prior qualifying study; b. BNP =65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: 1. 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; 2. Patients who have an ongoing SAE from a clinical study that is assessed by the investigator as related to bardoxolone methyl; 3. Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) while taking study drug; 4. Women who are pregnant or breastfeeding; 5. 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; 6. Known hypersensitivity to any component of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide continuing open-label treatment with bardoxolone methyl as part of this extended access program while collecting ongoing safety and tolerability data of bardoxolone methyl.;Secondary Objective: not applicable;Timepoint(s) of evaluation of this end point: Throughout the clinical trial.;Primary end point(s): Frequency, intensity, and relationship to study drug of adverse events (AEs) and serious adverse events (SAEs), and change from baseline in the following assessments: physical examinations, vital sign measurements, weight, urine albumin to creatinine ratio (UACR), and results of laboratory results. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Australia, France, Japan, Spain, United States
Contacts
Public ContactSTART UP UNIT
SERMES PLANIFICACION S.L
Outcome results
None listed