An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney Disease
An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney Disease
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.
Inclusion Criteria:
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:
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:
Glendale, Arizona 85306, United States
San Francisco, California 94143, United States
Saitama-shi, Saitama 330-8777, Japan
Bunkyō-Ku, Tokyo 113-8431, Japan
Bunkyō-Ku, Tokyo 113-8431, Japan
Minato-Ku, Tokyo 105-8470, Japan
Shinjuku-Ku, Tokyo 162-8666, Japan
Osaka, 834-0021, Japan