Diabetes Mellitus, Diabetic Nephropathy
Conditions
Keywords
Kidney disease
Brief summary
The purpose of this study is to determine whether a new investigational drug, pirfenidone, will be an effective therapy for diabetic patients with kidney dysfunction. Our hypothesis is that administration of pirfenidone to type 1 and type 2 diabetic patients with advanced kidney disease will lead to preservation of kidney function.
Detailed description
Diabetic kidney disease is the leading cause of new cases of kidney failure in the United States. In the kidneys of diabetic patients, there is accumulation of protein that leads to the formation of scar tissue and poor kidney function. Because of this many patients eventually require dialysis or kidney transplantation. A new investigational drug, pirfenidone, has been shown to be beneficial in a number of diseases in which scar formation leads to disease progression. It is our goal to examine whether pirfenidone is effective at stabilizing or reducing progressive diabetic kidney dysfunction.
Interventions
DRUGPirfenidone
Pirfenidone will be administered orally at 1200 or 2400 mg day in divided doses
Sponsors
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sharma, Kumar, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion * Type 1 or type 2 diabetes * Males and females greater than or equal to 18 years. * Abnormal kidney function determined by glomerular filtration rate * History of proteinuria * Blood pressure controlled to \<140/90 on anti-hypertensive medication Exclusion * Cancer, liver disease, hepatitis, HIV+ * History of heart attack, unstable angina, stroke or peptic ulcer in the past 6 months * Pregnant or planning to become pregnant during the study period * Other known kidney disease besides diabetic nephropathy * Expect to begin dialysis or receive a kidney transplant within 1 year of study enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the change in renal function from baseline to the end of the study period (12 months). | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| % change in urine albumin excretion from baseline to end of study period. | 12 months |
| % change in levels of TGF-b1 in urine, plasma and serum from baseline to end of study period. | 12 months |
| • Determine the relationship between % change in TGF-b1 levels and the change in GFR | 12 months |
Countries
United States
Outcome results
None listed