Could a cheap Fat-Lowering drug shield kidneys in type 1 diabetes?
NCT ID NCT04929379
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Diabetic nephropathies are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
- Which treatment works best for diabetic nerve pain?
- Can we predict kidney damage in young diabetics before it starts?
- A blood test that could spot kidney trouble in diabetes?
- One infusion, two targets: a uric-acid-lowering drug takes aim at heart and kidney disease in youth-onset diabetes
- Kidney clues may predict eye swelling after cataract surgery in diabetes patients
- Scientists probe kidney cell metabolism to unlock secrets of ANCA vasculitis