Low Dose Versus Aggressive Inhibition of the Renin-Angiotensin-Aldosterone (RAS) to Treat Microalbuminuria

Completed · Not applicable

Conditions studied: Microalbuminuria

In brief

The objective of the study is to assess the effect of standard versus aggressive inhibition of the renin-angiotensin system (RAS)in type 2 diabetic patients with microalbuminuria (MA) on; a)progression of microalbuminuria, b)estimated glomerular filtration rate (eGFR), c)endothelial dysfunction (measured by post-hyperemia arterial tonometry) and d)the slowing of the progression of atherosclerotic disease (measured by carotid intima media thickness \[CIMT\]).

Key facts

Study ID

NCT00907374

Run by

Charles Drew University of Medicine and Science

People needed

46

Starts

2005-07-01

Expected to finish

2009-04-01

Last updated by the study team

2012-03-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females, age 18-70
• Subjects with diabetic renal disease as defined by spot urine albumin - creatinine ratio 30-300mg/g and estimated glomerular filtration rate of >60 ml/min

You may not qualify if…

• Intake of non-steroidal anti-inflammatory agents (NSAIDs) more than 15 days/month, excluding aspirin.
• Inability to discontinue NSAIDs or aspirin for 5 days prior to GFR measurement.
• History of severe adverse reaction to any of the randomized drugs required for use in the protocol or contraindication of their use.
• Participation in another intervention study.
• Pregnancy or likelihood of becoming pregnant during the study period; lactation
• Clinical and laboratory evidence of any renal disease other than diabetic nephropathy.
• History of drug abuse in the past 2 years, including narcotics, cocaine or alcohol (> 21 drinks per week). Serious systemic disease that might influence survival or the course of renal disease. (Chronic oral steroid therapy is exclusion, but steroid-containing nasal sprays are not. Inactive sarcoidosis is not an exclusion).
• History of malignant or accelerated hypertension within 6 months prior to study entry; previous chronic peritoneal or hemodialysis or renal transplantation. Known secondary causes of hypertension. Spot urine albumin - creatinine ratio exceeding 300 (mg/g)
• Serum potassium level > 5.5 mEq/L for those not on ACE inhibitors during Baseline, or serum potassium level > 5.9 mEq/L for those on ACE inhibitors during Baseline.
• Leukopenia < 2,500/mm3 at screening and confirmed at the end of Baseline.
• Doubt that the participant will be able to adhere to medications or comply with the protocol visit schedule
• Arm Circumference > 52 cm, which precludes measuring blood pressure with the "thigh" blood pressure cuff. Arm length such that if the cuff circumference extended into the antecubital space so that the cuff interfered with placement of the stethoscope over the brachial artery for blood pressure measurement
• Clinical evidence of lead intoxication. Clinical evidence of congestive heart failure, current or within the preceding six months. Ejection fraction below 35% measured by any method. Heart block greater than first degree or any other arrhythmia that contraindicated the use of any of the primary BP drugs.

Where it is running

• Charles Drew University — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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