Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT04162366
Eligibility Criteria:
Inclusion Criteria:
* Prior treatment with at least 2 anti-hypertensive medications, at optimal or best tolerated 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 Glomerular Filtration Rate of at least 15 and below 60 mL/min/1.73m2 using the Chronic Kidney Disease-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 of run-in period).
* Agree to undertake pregnancy tests during the study and up to 30 days after randomized study treatment discontinuation.
* Agree to use highly-effective methods of contraception up to at least 30 days after study treatment discontinuation.
Exclusion Criteria:
* Mean sitting systolic blood pressure above 170 mmHg measured by "automated office blood pressure measurement" (AOBPM),
* Mean sitting diastolic blood pressure above 105 mmHg measured by AOBPM,
* Change in renal function requiring hospitalization, documented eGFR decline of greater than 20% in the 3 months prior to the screening visit, dialysis in the 3 months before the 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04162366
Study Brief:
Protocol Section:
NCT04162366