Clinical Trials

Inclusion Criteria:

• Male and female patients 18 ≤ age ≤ 70 upon study consent.
• Diagnosis of ADPKD by modified Pei-Ravine criteria:
  • at least 3 cysts per kidney by sonography or at least 5 cysts by CT or MRI with family history of ADPKD; or
  • 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 m^2 (18 to 55 years) or ≥ 30 to ≤ 44 mL/min/1.73 m^2 (56 to 70 years):
  • Patients with either screening eGFR ≥ 60 to ≤ 90 mL/min/1.73 m^2 or age 56 to 70 years, must have evidence of ADPKD progression (i.e., eGFR decline of ≥ 2.0 mL/min/1.73 m^2 per year, based on historical eGFR data and medical monitor discretion);
  • 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 ≤ 80 mmHg at Screen A visit after a period of rest. Patients receiving an angiotensin-converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) must be on a stable dose for at least 6 weeks prior to the Screen A visit.

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;