Low Dose Versus Aggressive Inhibition of the Renin-Angiotensin-Aldosterone (RAS) to Treat Microal… (NCT00907374) | Clinical Trial Compass
CompletedNot Applicable
Low Dose Versus Aggressive Inhibition of the Renin-Angiotensin-Aldosterone (RAS) to Treat Microalbuminuria
United States46 participantsStarted 2005-07
Plain-language summary
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 \[CIMT\]).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 i…
What they're measuring
1
Microalbuminuria Reported as Urinary Albumin:Creatinine Ratio
Timeframe: 3 to 36 months
Trial details
NCT IDNCT00907374
SponsorCharles Drew University of Medicine and Science