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A Pilot Study of Fenofibrate to Prevent Kidney Function Loss in Type 1 Diabetes
Sponsor: Alessandro Doria
Summary
Diabetic kidney disease remains the leading cause of end-stage kidney disease (ESKD), rising in frequency in parallel with the epidemic of diabetes worldwide. The estimated lifetime risk of kidney disease in persons with type 1 diabetes (T1D) has been reported to be as high as 50-70%, although risk may be lower in excellent care environments. Two previous studies have suggested that a generic drug used to lower fats in blood (fenofibrate) may protect the kidney from damage due to diabetes. These data, however, were obtained among people with type 2 diabetes with clinical characteristics optimized for cardiovascular studies. Thus, a clinical trial specifically designed to evaluate the effects on the kidney is required to firmly show that this drug can prevent kidney damage in T1D. The goals of the present pilot study are to demonstrate the feasibility of such trial, gather essential information for designing and planning this study, and generate preliminary data. To this end, 40 participants with T1D and early-to-moderate diabetic kidney disease (DKD), at high risk of ESKD, will be enrolled at two clinical sites and assigned in a 1:1 ratio to treatment with fenofibrate or placebo for 18 months. Kidney function will be measured at the beginning and at the end of the study to evaluate the effect of fenofibrate.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2022-01-04
Completion Date
2026-10-31
Last Updated
2026-02-06
Healthy Volunteers
No
Conditions
Interventions
Fenofibrate
145 mg oral fenofibrate daily for 76 weeks. Dosage is decreased to 48 mg daily if iGFR is or is estimated to be below 30 ml/min/1.73 m2.
Placebo
Inactive tablets identical to fenofibrate
Locations (4)
Joslin Diabetes Center
Boston, Massachusetts, United States
Lahey Hospital and Medical center
Burlington, Massachusetts, United States
Brehm Center for Diabetes Research / University of Michigan
Ann Arbor, Michigan, United States
SUNY Upstate Medical University
Syracuse, New York, United States