Fenofibrate for Type 1 Diabetes

(PERL-FENO Trial)

Recruiting at 3 trial locations

Overseen By Christine Mendonca

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Alessandro Doria

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Alessandro Doria, MD PhD MPH

Principal Investigator

Joslin Diabetes Center

Michael Mauer, MD

Principal Investigator

University of Minnesota

Eligibility Criteria

Adults aged 18-70 with Type 1 Diabetes and early-to-moderate kidney disease at high risk of progressing to end-stage kidney disease. Participants must have been treated with insulin within a year of diagnosis, have specific levels of kidney function, and be willing to follow the study plan. Exclusions include other health conditions like non-diabetic kidney diseases, allergies to fibrates or iodine, recent blood donations, pregnancy without contraception use, drug abuse history, certain medical histories including pancreatitis and cancer treatments.

Inclusion Criteria

I have diabetic kidney disease at high risk of worsening.

You have had type 1 diabetes for at least 8 years.

My kidney function, measured by eGFR, is between 40 and 99.9.

Exclusion Criteria

I have had gallstones but my gallbladder has been removed.

Your hemoglobin (a protein in red blood cells) level is too low (less than 11 g/dL for males, less than 10 g/dL for females) or your platelet count is too low (less than 100,000/mm3) at the time of screening.

My kidney disease is not caused by diabetes.

Treatment Details

Interventions

• Fenofibrate (Fibrate)

Trial Overview The trial is testing whether fenofibrate can prevent further damage in kidneys affected by diabetes in people with Type 1 Diabetes. Forty participants will either receive fenofibrate or a placebo for 18 months at two clinical sites. The main goal is to see if there's an improvement in their kidney function compared to those who just get the placebo.

Participant Groups

Group I: Fenofibrate Experimental Treatment 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

Inactive tablets identical to fenofibrate

Fenofibrate is already approved in Canada for the following indications:

Approved in Canada as Fenofibrate for:

• Hyperlipidemia
• Hypertriglyceridemia

Who Is Running the Clinical Trial?

Alessandro Doria

Lead Sponsor

Trials

3

Recruited

720+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+