Effects of Fenofibrate Therapy in Diabetic Nephropathy
Status:
Recruiting
Trial end date:
2021-04-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Singapore General Hospital
Collaborator:
National Medical Research Council (NMRC), Singapore