Last updated: November 22, 2022
Sponsor: Idorsia Pharmaceuticals Ltd.
Overall Status: Trial Not Available
Phase
3
Condition
Nephropathy
Williams Syndrome
Renal Failure
Treatment
N/AClinical Study ID
NCT04162366
ID-080A305
2018-003819-22
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Prior treatment with at least 2 anti-hypertensive medications, at optimal or besttolerated dose, of different pharmacological classes, including a diuretic,
- Participants with uncontrolled blood pressure (mean sitting systolic blood pressure of 140 mmHg or greater) and chronic kidney disease stage 3 or 4 (estimated GlomerularFiltration Rate of at least 15 and below 60 mL/min/1.73m2 using the Chronic KidneyDisease-Epidemiology equation),
- Women of childbearing potential are eligible only if the following applies:
- Negative pregnancy test at the screening visit and at baseline (i.e., end ofrun-in period).
- Agree to undertake pregnancy tests during the study and up to 30 days afterrandomized study treatment discontinuation.
- Agree to use highly-effective methods of contraception up to at least 30 daysafter study treatment discontinuation.
Exclusion
Exclusion Criteria:
- Mean sitting systolic blood pressure above 170 mmHg measured by "automated officeblood pressure measurement" (AOBPM),
- Mean sitting diastolic blood pressure above 105 mmHg measured by AOBPM,
- Change in renal function requiring hospitalization, documented eGFR decline of greaterthan 20% in the 3 months prior to the screening visit, dialysis in the 3 months beforethe screening visit,
- Planned dialysis or kidney transplant during the course of this study,
- Nephrotic syndrome defined as urine albumin-to-creatinine ratio above 3000 mg/g,
- Known and documented chronic heart failure.
Study Design
Study Start date:
January 01, 2020
Estimated Completion Date:
July 15, 2021