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ACTIVE NOT RECRUITING
NCT04929379
PHASE2

A Pilot Study of Fenofibrate to Prevent Kidney Function Loss in Type 1 Diabetes

Sponsor: Alessandro Doria

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

OTHER

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