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Effects of Fenofibrate Therapy in Diabetic Nephropathy

NCT03869931 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2020-12-14

No results posted yet for this study

Summary

Diabetic nephropathy (DN) is a common cause of end-stage renal disease (ESRD) and accounts for nearly half of all new patients starting dialysis in Singapore, the country with the highest rates of DN in the Asia-Pacific region. Despite the scale of the problem, little progress has been made in our understanding of the pathogenesis of the disorder and no new therapies have been offered.

The investigators have conducted a metabolomics study of human diabetic nephropathy that revealed evidence for alterations in mitochondrial fuel metabolism in patients with the disease, a finding also reported in other recent studies of human DN. Based on this finding the investigators believe that dysregulated mitochondrial fuel oxidation is a major driver of diabetic nephropathy.

Fenofibrate is an agonist of peroxisome-proliferator activating receptor (ppar)-alpha that is approved for the treatment of hypercholesterolaemia and hypertriglyceridemia alone or combined in patients unresponsive to dietary and other non-drug therapeutic measures. Fenofibrate is also indicated for the reduction in the progression of diabetic retinopathy in patients with type 2 diabetes and existing diabetic retinopathy. Presently fenofibrate is not indicated for the treatment of diabetic nephropathy.

The investigators hypothesize that treatment with fenofibrate, taken orally at 300mg per day or 100mg per day for 30 days will lead to significant changes in the circulating metabolomics patterns in patients with DN. The investigators propose to administer the drug for a period of 30 days and will perform a comprehensive analysis of the state of fuel metabolism in these patients before, and after the administration of fenofibrate using targeted metabolomics and other approaches. Fundal photography, Optical Coherence Tomography (OCT) and Optical Coherence Tomography Angiography (OCTA) will also be performed at baseline and post-treatment. A total of 300 subjects will be recruited from Singapore General Hospital (SGH) Diabetes and Metabolic Centre. Our goal is to discover key changes in fuel metabolism in DN patients receiving fenofibrate.

Conditions

Interventions

DRUG

Fenofibrate

Fenofibrate 100 mg or 300 mg (according to CrCl)

Sponsors & Collaborators

  • National Medical Research Council (NMRC), Singapore

    collaborator OTHER_GOV

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Hong Chang Tan, MBBS · Singapore General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-08
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03869931 on ClinicalTrials.gov