Autosomal Dominant Polycystic Kidney Disease
Conditions
Sponsors
Reata Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male and female patients 12 =< age =< 70 upon study consent;
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the off-treatment change from baseline in eGFR at Week 108 for patients receiving active drug, compared to patients receiving placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the off-treatment change from baseline in eGFR at Week 100 for patients receiving active drug, compared to patients receiving placebo. | — |
Countries
Europe, Japan, North America, Oceania
Outcome results
None listed