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Could a cheap Fat-Lowering drug shield kidneys in type 1 diabetes?

NCT ID NCT04929379

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests whether fenofibrate, a generic drug used to lower blood fats, can prevent kidney function loss in people with type 1 diabetes who are at high risk of kidney failure. Forty participants will receive either fenofibrate or a placebo for 18 months, and their kidney function will be measured. The goal is to gather data for a larger trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 18 and 70 years of age, inclusive. * Type 1 diabetes (T1D) continuously treated with insulin within one year from diagnosis. If the onset was after age 35, the presence of one or more of the following will also be required: a. documentation of the presence of circulating T1D-associated autoantibodies at diagnosis or at any other time; b. history of hospitalization for DKA; c. plasma C-peptide below the limit of detection with standard assay (with concurrent blood glucose \>100 mg/dl) * Duration of T1D ≥ 8 years. * Diabetic kidney disease at high risk of progression to ESKD, defined as follows: PERL allopurinol study participants: iGFR decline ≥3 ml/min/1.73 m2/year during the trial and micro- or macro-albuminuria (urinary albumin excretion rate \[AER\]=30-5000 mg/24 hr or albumin creatinine ratio \[ACR\]=30-5000 mg/g if not on renin-angiotensin system blocker (RASB) agents, or AER=18-5000 mg/24 hr or ACR 18-5000 mg/g range, if on RASB agents) on at least two occasions during the PERL allopurinol trial. All others participants: macroalbuminuria (AER=100-5000 mg/24 hrs or ACR=100-5000 mg/g) on two occasions during the three years before screening and/or at screening; * Estimated GFR (eGFR) based on serum creatinine between 40 and 99.9 ml/min/1.73 m2 at screening. The upper and the lower limits should be decreased by 1 ml/min/1.73 m2 for each year over age 60 (with a lower limit of 35 ml/min/1.73m2) and by 10 ml/min/1.73 m2 for strict vegans. * Valid baseline (Visit 2) iGFR measurement. * Current treatment with RASB, unless contraindicated; * Willing and able to comply with schedule of events and protocol requirements, including written informed consent. Exclusion Criteria: * Renal transplant or dialysis; * Non-diabetic kidney disease; * Allergy to fibrates or iodine containing substances; * Current therapy with fibrates or other PPAR-α agonists; * Specific contraindications or indications for fibrates; * History of photosensitive skin rash or myositis; * Persistent elevated unexplained blood creatinine phosphokinase level \>3 times the upper limit of normal; * History of pancreatitis, deep vein thrombosis (DVT) or pulmonary embolism; * History of cholelithiasis unless gallbladder has been removed; * Cancer treatment (excluding non-melanoma skin cancer treated by excision) within two years of screening; * Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites, or hepatic encephalopathy and/or diagnosis of cirrhosis based on liver biopsy, imaging, or elastography and/or aspartate or alanine aminotransferase (AST or ALT) \>2 times the upper limit of normal at screening and/or total bilirubin \>1.3 times the upper limit of normal at screening (in the case of Gilbert syndrome, direct bilirubin \>1.5 times the upper limit of normal at screening); * History of acquired immune deficiency syndrome or human immunodeficiency virus (HIV) infection; * Hemoglobin concentration \<11 g/dL (males), \<10 g/dL (females) or platelet count \<100,000/mm3 at screening; * Alcohol or drug abuse in the past 6 months; * Blood donation within 3 months of screening; * Breastfeeding, pregnancy, or unwillingness to be on contraception during the trial; * Poor mental function or any reasons to expect difficulty in complying with study requirements; * Serious medical problems other than diabetes, e.g. congestive heart failure, pulmonary insufficiency; * Participation in another interventional study. * Being incarcerated.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Brehm Center for Diabetes Research / University of Michigan

    Ann Arbor, Michigan, 48105, United States

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215, United States

  • Lahey Hospital and Medical center

    Burlington, Massachusetts, 01805, United States

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.