| Is your age between 18 yrs and 70 yrs? |
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| Gender: Male or Female |
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| Do you have Kidney Disease? |
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| Male and female patients 18 ≤ age ≤ 70 upon study consent |
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| Diagnosis of ADPKD by modified Pei-Ravine criteria |
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| ) at least 3 cysts per kidney by sonography or at least 5 cysts by CT or MRI |
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| with family history of ADPKD or |
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| ) at least 10 cysts per kidney by any radiologic method and exclusion of |
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| other cystic kidney diseases if without family history |
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| Screening eGFR (average of Screen A and Screen B eGFR values) ≥ 30 to ≤ |
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| mL/min/1.73 m2 (18 to 55 years) or ≥ 30 to ≤ 44 mL/min/1.73 m2 (56 to 70 |
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| years) |
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| a. Patients with either screening eGFR ≥ 60 to ≤ 90 mL/min/1.73 m2 or age 56 |
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| to 70 years, must have evidence of ADPKD progression (i.e., eGFR decline of ≥ |
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| 0 mL/min/1.73 m2 per year, based on historical eGFR data and medical monitor |
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| discretion) |
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| b. The two eGFR values collected at Screen A and Screen B visits used to |
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| determine eligibility must have a percent difference ≤ 25% |
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| Albumin to creatinine ratio (ACR) ≤ 2500 mg/g at Screen B visit |
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| Systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 80 |
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| mmHg at Screen A visit after a period of rest. Patients receiving an |
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| angiotensin-converting enzyme (ACE) inhibitor and/or an angiotensin II |
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| receptor blocker (ARB) must be on a stable dose for at least 6 weeks prior to |
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| the Screen A visit |
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| Adequate bone marrow reserve and organ function at the Screen A visit |
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| as follows |
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| a. Hematologic: Absolute neutrophil count > 1.5 x 109 /L, platelets > 100 x |
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| L, hemoglobin (Hgb) ≥ 9 g/dL |
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| b. Hepatic: Total bilirubin (TBL), alanine aminotransferase (ALT), and |
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| aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN) |
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| Able to swallow capsules |
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| Willing and able to comply with scheduled visits, treatment plan |
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| laboratory tests, and other study procedures |
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| Evidence of a personally signed and dated informed consent document |
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| indicating that the patient has been informed of all pertinent aspects of the |
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| study prior to initiation of any protocol-mandated procedures |
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| Prior exposure to bardoxolone methyl |
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| Patients previously treated with tolvaptan must have discontinued drug |
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| for at least 3 months prior to Screen A |
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| History of administration of polycystic kidney disease-modifying agents |
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| (somatostatin analogues) within 3 months prior to the Screen A visit |
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| B-type natriuretic peptide (BNP) level > 200 pg/mL at Screen A visit |
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| Uncontrolled diabetes (HbA1c > 11.0%) at Screen A visit |
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| Serum albumin < 3 g/dL at Screen A visit |
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| History of intracranial aneurysms |
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| Kidney or any other solid organ transplant recipient or a planned |
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| transplant during the study |
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| Acute dialysis or acute kidney injury within 12 weeks prior to Screen A |
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| visit or during Screening |
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| History of clinically significant left-sided heart disease and/or |
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| clinically significant cardiac disease, including but not limited to any of |
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| the following |
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| a. Clinically significant congenital or acquired valvular disease |
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| b. Left ventricular ejection fraction < 40% (based on echocardiogram performed |
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| at Screen A visit or within 6 months prior to Day 1) |
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| c. Pericardial constriction (based on echocardiogram performed at Screen A |
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| visit or within 6 months prior to Day 1) |
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| d. Restrictive or congestive cardiomyopathy (based on echocardiogram performed |
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| at Screen A visit or within 6 months prior to Day 1) |
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| e. Symptomatic coronary disease (prior myocardial infarction, percutaneous |
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| coronary intervention, coronary artery bypass graft surgery, or angina) |
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| f. History of hospitalization for heart failure |
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| g. Cardiac insufficiency, defined as New York Heart Association Class III or |
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| IV |
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| h. History of untreated atrial fibrillation |
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| i. History of unstable arrhythmias |
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| Systolic BP < 90 mm Hg at Screen A visit after a period of rest |
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| BMI < 18.5 kg/m2 at the Screen A visit |
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| History of malignancy within 5 years prior to Screen A visit, with the |
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| exception of localized skin or cervical carcinomas |
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| Systemic immunosuppression for more than 2 weeks, cumulatively, within |
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| the 12 weeks prior to randomization or anticipated need for immunosuppression |
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| during the study |
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| Untreated or uncontrolled active bacterial, fungal, or viral |
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| infection |
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| Participation in other interventional clinical studies within 30 days |
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| prior to Day 1 |
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| Unwilling to practice acceptable methods of birth control (both males |
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| who have partners of child-bearing potential and females of childbearing |
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| potential) during Screening, while taking study drug, and for at least 30 days |
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| after the last dose of study drug is ingested |
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| Women who are pregnant or breastfeeding |
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| Known hypersensitivity to any component of the study drug |
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| Any abnormal laboratory level that, in the opinion of the |
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| investigator, would put the patient at risk by trial enrollment |
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| Patient is, in the opinion of the investigator, unable to comply with |
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| the requirements of the study protocol or is unsuitable for the study for any |
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| reason |
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