Renoprotection in Early Diabetic Nephropathy in Pima Indians

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetic Nephropathy

In brief

This investigation is a randomized, double-blinded, placebo-controlled clinical trial in adult diabetic Pima Indians with normal urinary albumin excretion (albumin-to-creatinine ration less than 30 mg/g) or microalbuminuria (albumin-to-creatinine ration = 30-299 mg/g) to test the hypothesis that blockade of the renin-angiotensin system with the angiotensin receptor blocker (ARB) losartan can prevent or further attenuate the development and progression of early diabetic nephropathy in subjects with type 2 diabetes mellitus who are receiving standard diabetes care. One hundred seventy subjects were recruited for the study, all of whom had type 2 diabetes for at least 5 years, serum creatinine concentrations less than 1.4 mg/dl, and no evidence of non-diabetic renal diseases. Ninety-two of the subjects had normal urinary albumin excretion at baseline and other 78 had microalbuminuria. Subjects in each albumin excretion group were randomized to treatment with either the angiotensin II receptor antagonist, losartan, or placebo. Measurements of glomerular filtration rate (GFR), renal plasma flow (RPF) and fractional clearances of albumin and IgG will be made initially, at one month, and at 12-month intervals from baseline thereafter. A kidney biopsy was performed after six years in 111 subjects. Morphometric analysis of renal biopsies was used to determine differences in glomerular structure between treatment groups.

Key facts

Study ID

NCT00340678

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

170

Starts

1995-08-01

Expected to finish

2014-03-01

Last updated by the study team

2021-03-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects will be excluded for the following reasons:
• Clinically significant disorders of the liver, cardiovascular disease, cerebrovascular disease, peripheral vascular disease, pulmonary diseases, renal-urinary disorders, gastrointestinal disorders, or hematocrit levels less than or equal to 30 percent in women or less than or equal to 35 percent in men.
• Renovascular or malignant hypertension; uncontrolled hypertension despite treatment with three antihypertensive drugs; or hypertension that is being treated with antihypertensive medicines and the primary care physician or the patient refuses to adopt the blood pressure treatment regimen outlined in the study protocol.
• Hematuria of unknown etiology.
• Chronic debilitating disorders with or without treatment that would interfere with the assessment of kidney function or that might reduce the chances of survival for a sufficient length of time to evaluate efficacy of treatment.
• Currently receiving a drug regimen that includes: steroids, immunosuppressants, or investigational new drugs.
• Pregnancy. Women of childbearing potential must have a negative pregnancy test prior to entry and every three months during the study.
• Evidence of inability to empty the bladder.
• Hypersensitivity to angiotensin-converting enzyme inhibitors (ACEi), ARBs, or iodine.
• Bleeding disorders, since kidney biopsies could not be performed safely in these individuals.
• Massive obesity with body mass index greater than or equal to 45 kg/m(2).
• Non-diabetic renal disease.
• Conditions that are likely to interfere with informed consent or compliance with the protocol.

Where it is running

• NIDDK, Phoenix — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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