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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 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.

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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.

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

FieldValue
Enrollment Target 40 participants
Start Date 2022-01-04
Est. Completion 2026-10-31
Phase Phase 2

Sponsor

Alessandro Doria

3 total trials

What the Registry Record Tells You About NCT04929379

The ClinicalTrials.gov registry entry for NCT04929379 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 124-participant average among 12 other Diabetic Nephropathies trials with a reported enrollment target (68% lower). The listed sponsor is Alessandro Doria, which has 3 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 3 distinct geographic areas - top geographies include 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.

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