21177: A randomized, double-blind, placebo controlled, parallel-group, multicenter Phase 3 study to investigate the efficacy and safety of FInerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease

About this Study

The purpose of this study is to look at how well the new study drug, Finerenone, works in patients with non-diabetic chronic kidney disease.

Sponsor Protocol ID:21177
IRB Number:2022-48
Actively Enrolling
Phase 3
September 02, 2022
Eligibility Criteria
18 years old
Both Male and Female

Inclusion Criteria
  • Must be 18 years of age at time of signing the informed consent
  • Clinical diagnosis of chronic kidney disease
  • Stable and max tolerated labeled dose of an ACEI or ARB for at least 4 weeks prior to screening
  • Potassium less than or equal to 4.8 mmol/L

Exclusion Criteria
  • Type 1 or 2 diabetes mellitus or HbA1c greater than or equal to 6.5% 
  • Autosomal dominant or autosomal recessive polycystic kidney disease
  • Lupus nephritis or ANCA-associated vasculitis
  • Any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening
  • History of organ transplantation
  • Uncontrolled hypertension (greater than or equal to 160/100
  • Acute kidney injury requiring dialysis within the last 6 months
  • Heart failure decompensation, myocardial infarction, stroke, transient ischemic attach, pulmonary embolism, elective coronary artery bypass grafting within the last 3 months
  • Addison's disease
  • Pregnant or breast feeding or intention to become pregnant during the study
  • Participation in another interventional clinical study or treatment with any investigational medicinal product within 30 days prior to randomization

Categories Click category to view its trials.
Kidney/Renal Conditions
Participating Locations
Jackson Medical Mall (Children’s Clinics) - UMMC
Pavilion - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Delia Y. Owens
Phone Number: 601-815-9231
Email: dyowens@umc.edu
Principal Investigator:Shafi, Tariq
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