Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04929379 · ClinicalTrials.gov registry record · Phase 2
A Pilot Study of Fenofibrate to Prevent Kidney Function Loss in Type 1 Diabetes
A Phase 2 study of Diabetic Nephropathies, sponsored by Alessandro Doria.
- Active
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 4
- Study locations
NCT04929379: Active Phase 2 study of Diabetic Nephropathies, sponsored by Alessandro Doria.
NCT04929379 is a Phase 2 study of Diabetic Nephropathies that is active but no longer recruiting, run by Alessandro Doria. The registered enrollment target is 40 participants, below the 124-participant average among 12 other Diabetic Nephropathies trials with a reported enrollment target (68% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04929379, a Phase 2 study of Diabetic Nephropathies, is active but no longer recruiting, sponsored by Alessandro Doria.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 4
- Study locations
Study 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 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.
Primary Outcome
GFR measured by iohexol plasma disappearance (ml/min/1.73 m2), adjusted by its baseline value
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Fenofibrate
Study Locations (4)
Massachusetts
- Joslin Diabetes Center - Boston
- Lahey Hospital and Medical center - Burlington
Michigan
- Brehm Center for Diabetes Research / University of Michigan - Ann Arbor
New York
- SUNY Upstate Medical University - Syracuse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-01-04 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 2 |
What the registry record for NCT04929379 still lists
NCT04929379 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 124-participant average among 12 other Diabetic Nephropathies trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Diabetic Nephropathies appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04929379 reports a single indexed study location in Massachusetts, Michigan, New York.
Frequently Asked Questions
What is clinical trial NCT04929379 about?
NCT04929379 is a clinical study titled "A Pilot Study of Fenofibrate to Prevent Kidney Function Loss in Type 1 Diabetes". 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 ...
What is the current status of trial NCT04929379?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2022-01-04. Estimated completion is 2026-10-31.
What conditions does trial NCT04929379 study?
This clinical trial studies the following conditions: Diabetic Nephropathies.
What interventions are being tested in trial NCT04929379?
The interventions under investigation include: Placebo (OTHER), Fenofibrate (DRUG).
Who is sponsoring clinical trial NCT04929379?
This trial is sponsored by Alessandro Doria, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04929379 being conducted?
This trial has 4 study locations across Massachusetts, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Nephropathies
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04929379's enrollment target sits among peer trials
40 10th of 12 higher than 3 of 12 other Diabetic Nephropathies trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Nephropathies trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Formoterol in Diabetes
RECRUITING · Phase 2
-
Study of WAL0921 in Patients With Glomerular Kidney Diseases
RECRUITING · Phase 2
-
Evaluation of Coffee Therapy for Improvement of Renal Oxygenation
COMPLETED · Phase 2
-
A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Diabetic Kidney Disease
COMPLETED · Phase 2
-
Pathogenesis of Kidney Disease in Type 1 Diabetes: a Modern Kidney Biopsy Cohort (The PANDA Study)
RECRUITING
-
Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01306019 · 40 participants · Phase 1
Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)
- NCT01608152 · 40 participants
Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors
- NCT01668082 · 40 participants · NA
An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection
- NCT02015013 · 40 participants · Phase 2
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI