Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT07181135
Brief Summary:
Study to demonstrate efficacy of finerenone when compared to placebo in reducing albuminuria in participants with chronic kidney disease (CKD) not using renin-angiotensin-system (RAS) inhibitors.
Detailed Description:
FINE-START is a multicenter, international, randomized, placebo-controlled, double blind parallel-group Phase 3 study in adult participants with chronic kidney disease (CKD) not using renin-angiotensin-system (RAS) inhibitors. The study will enroll adults (≥18 years) with CKD defined as eGFR ≥25 and \<120 mL/min/1.73 m2, urinary albumin-to-creatinine ratio (UACR) ≥100 mg/g (11.3 mg/mmol) to \<5000 mg/g (565 mg/mmol) and documentation of elevated albuminuria or proteinuria. A total of 180 participants will be included and randomized with equal allocation (1:1) to Finerenone or placebo. Finerenone or placebo will be administered once daily for approximately 6 months. Change in UACR from baseline over 6 months will be used as a primary endpoint to demonstrate slowing of kidney disease progression. The aim of this study is to demonstrate efficacy of finerenone when compared to placebo in reducing albuminuria in participants with chronic kidney disease (CKD) not using renin-angiotensin-system (RAS) inhibitors.
Study:
NCT07181135
Study Brief:
Protocol Section:
NCT07181135