Diabetic NephropathiesPhase 2PERL-FENONCT04929379
A Pilot Study of Fenofibrate to Prevent Kidney Function Loss in Type 1 Diabetes
A Phase 2 study testing Fenofibrate in people with Diabetic Nephropathies, run by Alessandro Doria at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- Fenofibrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 Jan 2022to 31 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 20Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Brehm Center for Diabetes Research / University of Michigan
Ann Arbor, Michigan, 48105
Joslin Diabetes Center
Boston, Massachusetts, 02215
Lahey Hospital and Medical center
Burlington, Massachusetts, 01805
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
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.
Read the detailed description
Despite improvements in the past 20 years in glycemic and blood pressure control, and the introduction of "reno-protective" drugs such as renin-angiotensin system blockers (RASB), the overall incidence of end-stage kidney disease (ESKD) in type 1 diabetes (T1D) remains high. To seek new treatments to prevent diabetic kidney disease (DKD) and/or slow its progression to ESKD in T1D, the investigators have established a unique consortium of high-quality academic centers, which has been named PERL (Preventing Early Renal Function Loss in Diabetes) to emphasize the focus on intervening relatively early in the course of DKD in T1D, when renal damage can more likely be slowed or stopped. Findings from the FIELD and ACCORD trials suggest a reno-protective effect of the PPAR-alpha agonist fenofibrate, raising the exciting possibility of using this inexpensive generic drug to prevent GFR decline in persons with T1D. These data, however, were obtained through post-hoc analyses of type 2 diabetes (T2D) populations with clinical characteristics optimized for CVD studies. Thus, a clinical trial specifically designed to evaluate effects on GFR decline is required to firmly establish a DKD indication for fenofibrate in T1D. As a first step, the investigators are conducting a pilot study including 40 participants with T1D and early-to-moderate DKD, at high risk of ESKD, who will be enrolled at two of the PERL sites and randomized in a 1:1 ratio to treatment with fenofibrate or placebo for 18 months, followed by a two-month washout. The goal of this pilot study are to:
- Define the nature of the acute effect of fenofibrate on kidney function. It remains unclear whether the eGFR reduction observed at the beginning of fenofibrate treatment is an artifact of fenofibrate-induced changes in creatinine production and/or renal tubular handling, or corresponds to an actual reduction in GFR. This controversy, which has crucial implications for the pivotal trial design, will be resolved by directly measuring GFR by plasma iohexol disappearance - a methodology in which PERL sites are experienced.
- Generate further data on the long-term effects of fenofibrate on GFR decline in persons with T1D and DKD who are at high risk of rapid GFR decline and ESKD. The positive effects of fenofibrate in FIELD and ACCORD were observed in individuals who were not selected for having DKD and who, if untreated, had a mean GFR decline barely above the physiological decline due to aging. To make a compelling case for a pivotal trial for kidney outcomes, it is crucial to generate preliminary data on the effectiveness and safety of this drug in persons selected for having DKD and being rapidly progressing towards ESKD.
- Determine the effects of fenofibrate on biomarkers of increased risk of fast GFR decline. A salutary effect of fenofibrate on one or more of these biomarkers will corroborate any trend of a fenofibrate benefit identified in Aim 2.
The results of this pilot will allow the investigators to seek support for a pivotal trial to establish a kidney indication for fenofibrate in T1D.
- Conditions
- Diabetic Nephropathies
- Being tested
- Fenofibrate, Placebo
- Keywords
- type 1 diabetes, diabetic kidney disease, fibrates
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenofibrateDrug
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.
PlaceboOther
Inactive tablets identical to fenofibrate
| Study group | Role | What they receive |
|---|---|---|
| Fenofibrate | Experimental | 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. Receives: Drug: Fenofibrate |
| Placebo | Placebo comparator | Inactive tablets identical to fenofibrate Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline-adjusted iGFR at 8 weeks after randomization
GFR measured by iohexol plasma disappearance (ml/min/1.73 m2), adjusted by its baseline value
Measured: 8 weeks after randomization
Baseline-adjusted iGFR at the end of the drug wash-out period
GFR measured by iohexol plasma disappearance (ml/min/1.73 m2), adjusted by its baseline value
Measured: 84 weeks after randomization
Baseline-adjusted levels of serum biomarkers of increased ESKD risk at the end of the drug wash-out period
Levels of the following 21 serum biomarkers, adjusted by their baseline values: CD160, CD27, DLL1, EDA2R, EFNA4, EPHA2, GFRA1, IL1RT1, KIM1, LAYN, LTBR, PI3, PVRL4, RELT, SYND1, TNFR1, TNFR2, TNFRSF10A, TNFRSF4, TNFRSF6B, WFDC2
Measured: 84 weeks after randomization
Secondary outcomes (25)
Baseline-adjusted iGFR at the end of treatment
GFR measured by iohexol plasma disappearance (ml/min/1.73 m2), adjusted by its baseline value
Measured: 76 weeks after randomization
iGFR at the end of treatment
GFR measured by iohexol plasma disappearance (ml/min/1.73 m2), adjusted by its value at week 8
Measured: 76 weeks after randomization
Baseline-adjusted eGFR-SCr at 8 weeks after randomization
GFR estimated from serum creatinine (ml/min/1.73 m2) using the CKD-EPI equation, adjusted by its baseline value
Measured: 8 weeks after randomization
Baseline-adjusted eGFR-SCr at the end of treatment
GFR estimated from serum creatinine (ml/min/1.73 m2) using the CKD-EPI equation, adjusted by its baseline value
Measured: 76 weeks after randomization
eGFR-SCr at the end of treatment
GFR estimated from serum creatinine (ml/min/1.73 m2) using the CKD-EPI equation, adjusted by its value at week 8
Measured: 76 weeks after randomization
Baseline-adjusted eGFR-SCr at the end of the wash-out period
GFR estimated from serum creatinine (ml/min/1.73 m2) using the CKD-EPI equation, adjusted by its baseline value
Measured: 84 weeks after randomization
Baseline-adjusted eGFR-CysC at 8 weeks after randomization
GFR estimated from serum cystatin C (ml/min/1.73 m2) using the CKD-EPI equation, adjusted by its baseline value
Measured: 8 weeks after randomization
Baseline-adjusted eGFR-CysC at the end of treatment
GFR estimated from serum cystatin C (ml/min/1.73 m2) using the CKD-EPI equation, adjusted by its baseline value
Measured: 76 weeks after randomization
eGFR-CysC at the end of treatment
GFR estimated from serum cystatin C (ml/min/1.73 m2) using the CKD-EPI equation, adjusted by its value at week 8
Measured: 76 weeks after randomization
Baseline-adjusted eGFR-CysC at the end of the wash-out period
GFR estimated from serum cystatin C (ml/min/1.73 m2) using the CKD-EPI equation, adjusted by its baseline value
Measured: 84 weeks after randomization
Baseline-adjusted uAER at 8 weeks after randomization
Urinary Albumin excretion rate (uAER, mg/24/hr) based on overnight urine collection, adjusted by its baseline value
Measured: 8 weeks after randomization
Baseline-adjusted uAER at the end of treatment
Urinary albumin excretion rate (uAER, mg/24 hr) based on overnight urine collection, adjusted by its baseline value
Measured: 76 weeks after randomization
uAER at the end of treatment
Urinary Albumin excretion rate (uAER, mg/24 hr) based on overnight urine collection, adjusted by its value at week 8
Measured: 76 weeks after randomization
Baseline-adjusted uAER at the end of the wash-out period
Urinary albumin excretion rate (uAER, mg/24 hr) based on overnight urine collection, adjusted by its baseline value
Measured: 84 weeks after randomization
Baseline-adjusted creatinine clearance at 8 weeks after randomization
Creatinine clearance (ml/min) based on overnight urine collection, adjusted by its baseline value
Measured: 8 weeks after randomization
Baseline-adjusted ERPF at 8 weeks after randomization
Effective renal plasma flow (ml/min) measured by means of para-aminohippurate infusion, adjusted by its baseline value
Measured: 8 weeks after randomization
Baseline-adjusted afferent renal arteriolar resistance at 8 weeks after randomization
Afferent renal arteriolar resistance (dyne/s/cm5) measured by means of para-aminohippurate infusion, adjusted by its baseline value
Measured: 8 weeks after randomization
Baseline-adjusted efferent renal arteriolar resistance at 8 weeks after randomization
Efferent renal arteriolar resistance (dyne/s/cm5) measured by means of para-aminohippurate infusion, adjusted by its baseline value
Measured: 8 weeks after randomization
Baseline-adjusted glomerular hydrostatic pressure at 8 weeks after randomization
Glomerular hydrostatic pressure (mmHg) measured by means of para-aminohippurate infusion, adjusted by its baseline value
Measured: 8 weeks after randomization
Baseline-adjusted glomerular filtration pressure at 8 weeks after randomization
Glomerular filtration pressure (mmHg) measured by means of para-aminohippurate infusion, adjusted by its baseline value
Measured: 8 weeks after randomization
Baseline-adjusted glomerular oncotic pressure at 8 weeks after randomization
Glomerular oncotic pressure (mmHg) measured by means of para-aminohippurate infusion, adjusted by its baseline value
Measured: 8 weeks after randomization
eGFR-SCr trajectory
Trajectory of GFR estimated from serum creatinine (ml/min/year/1.73 m2) using the CKD-EPI equation
Measured: 8 to 76 weeks from randomization
eGFR-SCys trajectory
Trajectory of GFR estimated from serum cystatin C (ml/min/year/1.73 m2) using the CKD-EPI equation
Measured: 8 to 76 weeks from randomization
Baseline-adjusted levels of serum biomarkers of increased ESKD risk at the end of treatment
Levels of the following 21 serum biomarkers, adjusted by their baseline values: CD160, CD27, DLL1, EDA2R, EFNA4, EPHA2, GFRA1, IL1RT1, KIM1, LAYN, LTBR, PI3, PVRL4, RELT, SYND1, TNFR1, TNFR2, TNFRSF10A, TNFRSF4, TNFRSF6B, WFDC2
Measured: 76 weeks after randomization
Levels of serum biomarkers of increased ESKD risk at the end of treatment
Levels of the following 21 serum biomarkers, adjusted by their values at week 8: CD160, CD27, DLL1, EDA2R, EFNA4, EPHA2, GFRA1, IL1RT1, KIM1, LAYN, LTBR, PI3, PVRL4, RELT, SYND1, TNFR1, TNFR2, TNFRSF10A, TNFRSF4, TNFRSF6B, WFDC2
Measured: 76 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start4 Jan 2022
- Primary completion1 May 2025
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alessandro Doria
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, University of Minnesota
- Responsible party
- Sponsor-investigator, Alessandro Doria, Joslin Diabetes Center
- Investigators
- Alessandro Doria, MD PhD MPH, Principal investigator, Joslin Diabetes CenterMichael Mauer, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929379
- Sponsor's protocol ID
- STUDY00000156
- Acronym
- PERL-FENO
- Status last verified
- Feb 2026
- First submitted
- 3 Jun 2021
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final research data will be formatted as a computerized dataset at the Joslin Diabetes Center. The final dataset will include both raw data and derived variables, which will be described in documents associated with the dataset. We will maintain the primary dataset for a minimum of 3 years following closeout of the grant as stipulated under the NIH Grants Policy Statement. In agreement with NIH's policy on the sharing of data from large, NIH-sponsored studies, the data collected in the course of the study will be archived in de-identified form in an NIH Central Repository for future distribution to the scientific community.
Publications
Davis TM, Ting R, Best JD, Donoghoe MW, Drury PL, Sullivan DR, Jenkins AJ, O'Connell RL, Whiting MJ, Glasziou PP, Simes RJ, Kesaniemi YA, Gebski VJ, Scott RS, Keech AC; Fenofibrate Intervention and Event Lowering in Diabetes Study investigators. Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study. Diabetologia. 2011 Feb;54(2):280-90. doi: 10.1007/s00125-010-1951-1. Epub 2010 Nov 4.
PubMed 21052978Frazier R, Mehta R, Cai X, Lee J, Napoli S, Craven T, Tuazon J, Safdi A, Scialla J, Susztak K, Isakova T. Associations of Fenofibrate Therapy With Incidence and Progression of CKD in Patients With Type 2 Diabetes. Kidney Int Rep. 2018 Sep 18;4(1):94-102. doi: 10.1016/j.ekir.2018.09.006. eCollection 2019 Jan.
PubMed 30596172
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Fenofibrate to Prevent Kidney Function Loss in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04929379
- Acronym / sponsor ID
- PERL-FENO / STUDY00000156
- Conditions
- Diabetic Nephropathies
- Keywords
- type 1 diabetes, diabetic kidney disease, fibrates
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Alessandro DoriaUniversity, hospital or other
- Collaborators
- University of Michigan, University of Minnesota
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite improvements in the past 20 years in glycemic and blood pressure control, and the introduction of "reno-protective" drugs such as renin-angiotensin system blockers (RASB), the overall incidence of end-stage kidney disease (ESKD) in type 1 diabetes (T1D) remains high. To seek new treatments to prevent diabetic kidney disease (DKD) and/or slow its progression to ESKD in T1D, the investigators have established a unique consortium of high-quality academic centers, which has been named PERL (Preventing Early Renal Function Loss in Diabetes) to emphasize the focus on intervening relatively early in the course of DKD in T1D, when renal damage can more likely be slowed or stopped. Findings from the FIELD and ACCORD trials suggest a reno-protective effect of the PPAR-alpha agonist fenofibrate, raising the exciting possibility of using this inexpensive generic drug to prevent GFR decline in persons with T1D. These data, however, were obtained through post-hoc analyses of type 2 diabetes (T2D) populations with clinical characteristics optimized for CVD studies. Thus, a clinical trial specifically designed to evaluate effects on GFR decline is required to firmly establish a DKD indication for fenofibrate in T1D. As a first step, the investigators are conducting a pilot study including 40 participants with T1D and early-to-moderate DKD, at high risk of ESKD, who will be enrolled at two of the PERL sites and randomized in a 1:1 ratio to treatment with fenofibrate or placebo for 18 months, followed by a two-month washout. The goal of this pilot study are to:
- Define the nature of the acute effect of fenofibrate on kidney function. It remains unclear whether the eGFR reduction observed at the beginning of fenofibrate treatment is an artifact of fenofibrate-induced changes in creatinine production and/or renal tubular handling, or corresponds to an actual reduction in GFR. This controversy, which has crucial implications for the pivotal trial design, will be resolved by directly measuring GFR by plasma iohexol disappearance - a methodology in which PERL sites are experienced.
- Generate further data on the long-term effects of fenofibrate on GFR decline in persons with T1D and DKD who are at high risk of rapid GFR decline and ESKD. The positive effects of fenofibrate in FIELD and ACCORD were observed in individuals who were not selected for having DKD and who, if untreated, had a mean GFR decline barely above the physiological decline due to aging. To make a compelling case for a pivotal trial for kidney outcomes, it is crucial to generate preliminary data on the effectiveness and safety of this drug in persons selected for having DKD and being rapidly progressing towards ESKD.
- Determine the effects of fenofibrate on biomarkers of increased risk of fast GFR decline. A salutary effect of fenofibrate on one or more of these biomarkers will corroborate any trend of a fenofibrate benefit identified in Aim 2.
The results of this pilot will allow the investigators to seek support for a pivotal trial to establish a kidney indication for fenofibrate in T1D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fenofibrate | Experimental | Drug: Fenofibrate145 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. |
| Placebo | Placebo comparator | Other: PlaceboInactive tablets identical to fenofibrate |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fenofibrate145 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. | Drug | Fenofibrate |
| PlaceboInactive tablets identical to fenofibrate | Other | Placebo |
Primary outcome
Baseline-adjusted iGFR at 8 weeks after randomization
Time frame: 8 weeks after randomization
GFR measured by iohexol plasma disappearance (ml/min/1.73 m2), adjusted by its baseline value
Baseline-adjusted iGFR at the end of the drug wash-out period
Time frame: 84 weeks after randomization
GFR measured by iohexol plasma disappearance (ml/min/1.73 m2), adjusted by its baseline value
Baseline-adjusted levels of serum biomarkers of increased ESKD risk at the end of the drug wash-out period
Time frame: 84 weeks after randomization
Levels of the following 21 serum biomarkers, adjusted by their baseline values: CD160, CD27, DLL1, EDA2R, EFNA4, EPHA2, GFRA1, IL1RT1, KIM1, LAYN, LTBR, PI3, PVRL4, RELT, SYND1, TNFR1, TNFR2, TNFRSF10A, TNFRSF4, TNFRSF6B, WFDC2
25 secondary outcomes
Baseline-adjusted iGFR at the end of treatment
Time frame: 76 weeks after randomization
iGFR at the end of treatment
Time frame: 76 weeks after randomization
Baseline-adjusted eGFR-SCr at 8 weeks after randomization
Time frame: 8 weeks after randomization
Baseline-adjusted eGFR-SCr at the end of treatment
Time frame: 76 weeks after randomization
eGFR-SCr at the end of treatment
Time frame: 76 weeks after randomization
Baseline-adjusted eGFR-SCr at the end of the wash-out period
Time frame: 84 weeks after randomization
Baseline-adjusted eGFR-CysC at 8 weeks after randomization
Time frame: 8 weeks after randomization
Baseline-adjusted eGFR-CysC at the end of treatment
Time frame: 76 weeks after randomization
eGFR-CysC at the end of treatment
Time frame: 76 weeks after randomization
Baseline-adjusted eGFR-CysC at the end of the wash-out period
Time frame: 84 weeks after randomization
Baseline-adjusted uAER at 8 weeks after randomization
Time frame: 8 weeks after randomization
Baseline-adjusted uAER at the end of treatment
Time frame: 76 weeks after randomization
uAER at the end of treatment
Time frame: 76 weeks after randomization
Baseline-adjusted uAER at the end of the wash-out period
Time frame: 84 weeks after randomization
Baseline-adjusted creatinine clearance at 8 weeks after randomization
Time frame: 8 weeks after randomization
Baseline-adjusted ERPF at 8 weeks after randomization
Time frame: 8 weeks after randomization
Baseline-adjusted afferent renal arteriolar resistance at 8 weeks after randomization
Time frame: 8 weeks after randomization
Baseline-adjusted efferent renal arteriolar resistance at 8 weeks after randomization
Time frame: 8 weeks after randomization
Baseline-adjusted glomerular hydrostatic pressure at 8 weeks after randomization
Time frame: 8 weeks after randomization
Baseline-adjusted glomerular filtration pressure at 8 weeks after randomization
Time frame: 8 weeks after randomization
Baseline-adjusted glomerular oncotic pressure at 8 weeks after randomization
Time frame: 8 weeks after randomization
eGFR-SCr trajectory
Time frame: 8 to 76 weeks from randomization
eGFR-SCys trajectory
Time frame: 8 to 76 weeks from randomization
Baseline-adjusted levels of serum biomarkers of increased ESKD risk at the end of treatment
Time frame: 76 weeks after randomization
Levels of serum biomarkers of increased ESKD risk at the end of treatment
Time frame: 76 weeks after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Background: PubMed 21052978Davis TM, Ting R, Best JD, Donoghoe MW, Drury PL, Sullivan DR, Jenkins AJ, O'Connell RL, Whiting MJ, Glasziou PP, Simes RJ, Kesaniemi YA, Gebski VJ, Scott RS, Keech AC; Fenofibrate Intervention and Event Lowering in Diabetes Study investigators. Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study. Diabetologia. 2011 Feb;54(2):280-90. doi: 10.1007/s00125-010-1951-1. Epub 2010 Nov 4.
- Background: PubMed 30596172Frazier R, Mehta R, Cai X, Lee J, Napoli S, Craven T, Tuazon J, Safdi A, Scialla J, Susztak K, Isakova T. Associations of Fenofibrate Therapy With Incidence and Progression of CKD in Patients With Type 2 Diabetes. Kidney Int Rep. 2018 Sep 18;4(1):94-102. doi: 10.1016/j.ekir.2018.09.006. eCollection 2019 Jan.
- Individual participant dataSharing planned: Yes. Final research data will be formatted as a computerized dataset at the Joslin Diabetes Center. The final dataset will include both raw data and derived variables, which will be described in documents associated with the dataset. We will maintain the primary dataset for a minimum of 3 years following closeout of the grant as stipulated under the NIH Grants Policy Statement. In agreement with NIH's policy on the sharing of data from large, NIH-sponsored studies, the data collected in the course of the study will be archived in de-identified form in an NIH Central Repository for future distribution to the scientific community.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Doria, MD PhD MPH principal investigator
Joslin Diabetes Center
Michael Mauer, MD principal investigator
University of Minnesota
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fenofibrate in people with Diabetic Nephropathies, run by Alessandro Doria at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline-adjusted iGFR at 8 weeks after randomization (time frame: 8 weeks after randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04929379, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.