Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biogen
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX
