Status:
UNKNOWN
Effects of Fenofibrate Therapy in Diabetic Nephropathy
Lead Sponsor:
Singapore General Hospital
Collaborating Sponsors:
National Medical Research Council (NMRC), Singapore
Conditions:
Diabetes Mellitus
Diabetic Nephropathies
Eligibility:
All Genders
21-100 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
In this single-centre, open label study, 300 adults with DN will be recruited over 3 years. Following screening and baseline metabolic evaluations, eligible subjects will be treated with fenofibrate f...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Man or woman between 21 and 100 years of age
- Type 2 diabetes mellitus Increased urine protein excretion as defined as:
- More than one measurement in the past 1-year with urine microalbumin/creatinine ratio (ACR) \> 3.3 mg/mmol creatinine, or urine total protein/creatinine ratio (PCR) \> 0.2 g/urine creatinine, or creatinine clearance between 30-60 ml/min
- More than one measurement in the past 1-year with urine microalbumin/creatinine ratio (ACR) \> 3.3 mg/mmol creatinine or urine total protein/creatinine ratio (PCR) \> 0.2 g/urine creatinine
- Known diabetes duration \> 3 months
- HbA1c \< 9%(within 3 months prior to enrolment)
- No change in dose of diabetes medications by more than two-fold or new agents added within the previous 3 months
- No change in dose of lipid-lowering medications by more than two-fold or new agents added within the previous 3 months
- Capable of providing informed consent
- Exclusion Criteria
- Type 1 diabetes mellitus
- Known intolerance or allergic to statins
- Known intolerance or allergic to fenofibrate
- Known intolerance or allergic to peanut oil or soybean lecithin or related products
- Concurrent use of fibrates
- Concurrent use Colchicine
- Concurrent use Nicotinic Acid
- Concurrent use Cyclosporine
- Concurrent use Tacrolimus
- Concurrent use Amodiaquine
- Concurrent use Bile acid sequestrants
- Concurrent use Chenodiol
- Concurrent use Ciprofibrate
- Oral anticoagulants: vitamin K antagonist (e.g. warfarin), factor Xa inhibitors (eg. rivaroxaban, apixaban and dabigatran)
- Concurrent use Anti-obesity medications (e.g. phentermine, orlistat)
- Concurrent use Systemic steroids (e.g. prednisolone, hydrocortisone, dexamethasone)
- Hepatitis B
- Hepatitis C
- Autoimmune hepatitis
- Hemochromatosis
- Previous pancreatitis
- Serum alanine aminotransferase or aspartate aminotransferase above 2x upper limit of normal
- Serum creatinine kinase above upper limit of normal
- Creatinine clearance \< 30 ml/min
- Renal replacement therapy
- Presence of any non-DN renal glomerular disease
- Any previous organ transplantation
- Previous bariatric surgery
- Gallbladder disease
- Untreated hypothyroidism
- Untreated thyrotoxicosis
- Hemoglobin \< 10 g/L
- Any leukopenia
- Any thrombocytopenia)
- Cancer within the last 5 years (except basal cell carcinoma)
- Medical condition likely to limit survival to less than 3 years
- Currently participation in another clinical trial
- Pregnancy, or currently trying to become pregnant
- Nursing mothers
- Hospitalization within 1 month prior to enrolment
- Alcohol intake \> 1 unit per day for women or \> 2 units per day for men
- Any factors likely to limit adherence to interventions
- Any ongoing acute medical illness
- Failure to obtain informed consent from participant
Exclusion
Key Trial Info
Start Date :
March 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2021
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03869931
Start Date
March 8 2019
End Date
April 30 2021
Last Update
December 14 2020
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore, 169856