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22267 FINE-ONE: A parallel-group, randomized, prospective, interventional, double-blind, multicenter global Phase 3 study to investigate the efficacy and safety of Finerenone versus placebo, in addition to standard of care, in participants with chronic ki

NCT05901831

FINE-ONE: A parallel-group, randomized, prospective, interventional, double-blind, multicenter global Phase 3 study to investigate the efficacy and safety of Finerenone versus placebo, in addition to standard of care, in participants with chronic kidney disease and type 1 diabetes

Principal Investigator

Sponsor

Bayer Healthcare Pharmaceuticals Inc.

Study Purpose: The aim of the study is to demonstrate efficacy of Finerenone when compared to placebo, in addition to standard of care, in delaying the progression of chronic kidney disease (CKD) in participants with CKD and T1D. To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the following criteria: Study Duration: up to 8 months Study Commitment: One consenting visit One screening visit Five outpatient visits Other visits may be required. Age: 18 years old Sex: Male & Female Conditions/Eligibility: Type 1 Diabetes and Chronic Kidney Disease Must be on a stable dose of and ACEi OR ARB (not both) No Kidney transplants No Type 2 Diabetes Study Procedures: Informed Consent Demographics collection Health and medication history Physical Exam ECG Blood and urine collection Vital signs (height, weight, HR, BP) Study Medication administration Compensation: $775

This study is currently enrolling.