Clinical trial NCT03366337 (phase 2, status: completed)
Conditions: iga nephropathy, ckd associated with type 1 diabetes, focal segmental glomerulosclerosis, autosomal dominant polycystic kidney
ICD codes: N14.0, N15.0, A36.84, B58.83, B52.0, N13.71, N14.3, K55.021, K55.041, M99.00, M99.01, M99.02, M99.03, M99.04
Drugs: bardoxolone methyl capsules
SMILES: COC(=O)[C@]12CCC(C)(C)C[C@H]1[C@H]1C(=O)C=C3[C@@]4(C)C=C(C#N)C(=O)C(C)(C)[C@@H]4CC[C@@]3(C)[C@]1(C)CC2
Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients 18 ≤ age ≤ 65 upon study consent;

          -  Screening eGFR (average of Screen A and Screen B eGFR values) ≥ 30 and ≤ 90
             mL/min/1.73 m2. 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;

          -  If receiving an angiotensin-converting enzyme (ACE) inhibitor and/or an angiotensin II
             receptor blocker (ARB), patients should be prescribed the maximally tolerated labeled
             daily dose (MTLDD) for at least 6 weeks prior to the Screen A visit;

          -  For patients enrolling in T1D Cohort: Diagnosis of type 1 diabetes confirmed by
             fasting C-peptide level. Diagnosis must have been made ≤ 35 years of age; and
             prescribed stable dose of insulin to maintain adequate glucose control for at least 6
             months prior to the Screen A visit;

          -  For patients enrolling in IgAN Cohort: Biopsy-confirmed IgA nephropathy;

          -  For patients enrolling in FSGS Cohort: Biopsy-confirmed FSGS that is not due to known
             secondary causes including morbid obesity, decreased renal mass, viral infections,
             drug-induced nephrotoxicity, or prior history of vasculitis;

          -  For patients enrolling in ADPKD Cohort: Genetic confirmation of PKD1 mutation;

          -  Adequate bone marrow reserve and organ function at the Screen A visit as follows:
             Hematologic: Absolute neutrophil count > 1.5 x 109/L, platelets > 100 x 109/L,
             hemoglobin (Hgb) ≥ 9 g/dL; and Hepatic: Total bilirubin (TBL) ≤ 1.5 times the upper
             limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase
             (AST) ≤ 1.5 times ULN.

        Exclusion Criteria:

          -  Kidney or any other solid organ transplant recipient or a planned transplant during
             the study;

          -  B-type natriuretic peptide (BNP) level > 200 pg/mL at Screen A visit;

          -  Acute dialysis or acute kidney injury within 12 weeks prior to Screen A visit or
             during Screening;

          -  Serum albumin < 3 g/dL at Screen A visit;

          -  Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks
             prior to randomization or anticipated need for immunosuppression during the study;

          -  For patients enrolling in IgAN Cohort: Systemic manifestations of Henoch-Schonlein
             purpura within 1 year prior to Screen A visit; or have used belimumab, eculizumab, or
             rituximab within 6 months prior to Screen A visit;

          -  For patients enrolling in ADPKD Cohort: Receiving tolvaptan;

          -  Cerebrovascular event (stroke, transient ischemic attack) or aneurysm within 6 months
             prior to Screen A visit or during Screening;

          -  History of clinically significant left-sided heart disease and/or clinically
             significant cardiac disease;

          -  Uncontrolled systemic hypertension;

          -  Systolic BP < 90 mm Hg at Screen A visit after a period of rest;

          -  History of malignancy within 2 years prior to Screen A visit, with the exception of
             localized skin or cervical carcinomas;

          -  Uncontrolled diabetes (HbA1c > 10.0%) at Screen A visit;

          -  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.