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
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Enrollment
This study is currently enrolling. -
Research Area
Translational Research -
Location
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Principal Investigator
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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
Enrollment Form
This study is currently enrolling.