Renin Angiotensin System Study (RASS/B-RASS)

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine if renin angiotensin medications can prevent or delay the onset of diabetic kidney disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Michael Mauer, MD
• Collaborators: Canadian Institutes of Health Research (CIHR); Merck Frosst Canada Ltd.; Merck Sharp & Dohme Corp.; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Enalapril; Losartan

Criteria

Inclusion Criteria:

• type 1 diabetic (DM) for 2-20 yrs

• type 1 DM onset prior to 45; if onset was between ages 31-41, BMI <26; onset 41-45, positive GAD or ICA required

• normal or increased GFR

• normal BP

• normoalbuminuric (<20 ug/min on 2 of 3 time overnight urine collections)

Exclusion Criteria:

• type 1 DM duration longer than 20 yrs

• hypertension (>85/135 mmHg)

• reduced GFR (<90 ml/min/1.73m2)

• microalbuminuria

• solitary kidney or evidence of unilateral renal disease

• evidence of other important kidney disease by history, ultrasound or biopsy

• other chronic diseases or conditions such as cystic fibrosis, serious mental illness, severe mental retardation, etc.

• pregnancy or females planning pregnancy within 2 years were excluded due to the drugs being used

• compliance (pt not taking at least 85% of two week placebo were excluded)