Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial
will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients
with ADPKD. Approximately 850 patients will be enrolled.
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Chronic Kidney Disease
Enrollment Eligibility
Inclusion Criteria:
- Male and female patients 12 ≤ age ≤ 70 upon study consent;
- Diagnosis of ADPKD by modified Pei-Ravine criteria: 1) at least 3 cysts per kidney by
sonography or at least 5 cysts by CT or MRI with family history of ADPKD or 2) at
least 10 cysts per kidney by any radiologic method and exclusion of other cystic
kidney diseases if without family history;
- Screening eGFR (average of Screen A and Screen B eGFR values) ≥ 30 to≤ 90 mL/min/1.73
m2 (18 to 55 years) or ≥ 30 to ≤ 44 mL/min/1.73 m2 (56 to 70 years):
1) Patients with either screening eGFR ≥ 60 to ≤ 90 mL/min/1.73 m2 or age 56 to 70
years, must have evidence of ADPKD progression (i.e., eGFR decline of ≥ 2.0
mL/min/1.73 m2 per year, based on historical eGFR data and medical monitor
discretion); 2)The two eGFR values collected at Screen A and Screen B visits used to
determine eligibility must have a percent difference ≤ 25%;
- Albumin to creatinine ratio (ACR) ≤ 2500 mg/g at Screen B visit;
- Systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at Screen A
visit after a period of rest.
Exclusion Criteria:
- History of administration of polycystic kidney disease-modifying agents (somatostatin
analogues) within 3 months prior to the Screen A visit;
- B-type natriuretic peptide (BNP) level > 200 pg/mL at Screen A visit;
- Uncontrolled diabetes (HbA1c > 11.0%) at Screen A visit;
- Serum albumin < 3 g/dL at Screen A visit;
- History of intracranial aneurysms;
- Kidney or any other solid organ transplant recipient or a planned transplant during
the study;
- Acute dialysis or acute kidney injury within 12 weeks prior to Screen A visit or
during Screening;
- History of clinically significant left-sided heart disease and/or clinically
significant cardiac disease;
- Systolic BP < 90 mm Hg at Screen A visit after a period of rest;
- BMI < 18.5 kg/m2 at the Screen A visit;
- History of malignancy within 5 years prior to Screen A visit, with the exception of
localized skin or cervical carcinomas;
- Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks
prior to randomization or anticipated need for immunosuppression during the study;
- Untreated or uncontrolled active bacterial, fungal, or viral infection;
- Participation in other interventional clinical studies within 30 days prior to Day 1;
- Unwilling to practice acceptable methods of birth control (both males who have
partners of child-bearing potential and females of childbearing potential) during
Screening, while taking study drug, and for at least 30 days after the last dose of
study drug is ingested;
- Women who are pregnant or breastfeeding;
- Concomitant use of tolvaptan is excluded. Patients previously treated with tolvaptan
must have discontinued drug for at least 3 months prior to Screen A visit