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Fibrate

Fenofibrate for Type 1 Diabetes (PERL-FENO Trial)

Phase 2
Recruiting
Led By Alessandro Doria, MD PhD MPH
Research Sponsored by Alessandro Doria
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Estimated GFR (eGFR) based on serum creatinine between 40 and 99.9 ml/min/1.73 m2 at screening
Current treatment with RASB, unless contraindicated
Must not have
History of cholelithiasis unless gallbladder has been removed
Non-diabetic kidney disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 to 76 weeks from randomization

Summary

This trial is to test whether the generic drug fenofibrate can prevent kidney damage in people with type 1 diabetes. 40 participants will be enrolled and given either fenofibrate or placebo for 18 months. Kidney function will be measured at the beginning and end of the study.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Fenofibrate may cause side effects such as inflammation of the liver or gallbladder (like gallstones), muscle pain or weakness (myopathy), increased sensitivity to sunlight leading to skin rashes, digestive issues like stomach pain or nausea, and potential increase in liver enzymes indicating liver stress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function, measured by eGFR, is between 40 and 99.9.
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I am currently taking a RAS blocker, unless it's not recommended for me.
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I am between 18 and 70 years old.
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I have Type 1 diabetes and started insulin within a year of diagnosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had gallstones but my gallbladder has been removed.
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My kidney disease is not caused by diabetes.
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I am currently taking medication that affects fat metabolism.
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I have had pancreatitis, DVT, or a pulmonary embolism in the past.
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I am not pregnant, breastfeeding, and agree to use contraception during the trial.
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I have had a kidney transplant or am on dialysis.
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I cannot take fibrates due to specific health reasons.
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I have serious health issues besides diabetes.
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I have or had severe liver damage.
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I have a history of AIDS or HIV infection.
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I have had a skin rash or muscle inflammation caused by light.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 to 76 weeks from randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 to 76 weeks from randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Baseline-adjusted iGFR at 8 weeks after randomization
Baseline-adjusted iGFR at the end of the drug wash-out period
Tumor Markers
Secondary study objectives
Baseline-adjusted ERPF at 8 weeks after randomization
Kidney
Baseline-adjusted creatinine clearance at 8 weeks after randomization
+22 more

Side effects data

From 2019 Phase 3 trial • 551 Patients • NCT03001817
1%
Nasopharyngitis
1%
Angina unstable
100%
80%
60%
40%
20%
0%
Study treatment Arm
K-877 and Fenofibrate Placebo: 40-Week Extension
K-877: 12-Week Efficacy
Placebo: 12-Week Efficacy
Fenofibrate and K-877 Placebo: 40-Week Extension

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: FenofibrateExperimental Treatment1 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: PlaceboPlacebo Group1 Intervention
Inactive tablets identical to fenofibrate
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fenofibrate
2018
Completed Phase 4
~6500

Find a Location

Who is running the clinical trial?

University of MinnesotaOTHER
1,434 Previous Clinical Trials
1,621,662 Total Patients Enrolled
University of MichiganOTHER
1,854 Previous Clinical Trials
6,433,521 Total Patients Enrolled
Alessandro DoriaLead Sponsor
2 Previous Clinical Trials
680 Total Patients Enrolled

Media Library

Fenofibrate (Fibrate) Clinical Trial Eligibility Overview. Trial Name: NCT04929379 — Phase 2
Diabetic Kidney Disease Research Study Groups: Fenofibrate, Placebo
Diabetic Kidney Disease Clinical Trial 2023: Fenofibrate Highlights & Side Effects. Trial Name: NCT04929379 — Phase 2
Fenofibrate (Fibrate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04929379 — Phase 2
~5 spots leftby May 2025
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