Status:
COMPLETED
Low Dose Versus Aggressive Inhibition of the Renin-Angiotensin-Aldosterone (RAS) to Treat Microalbuminuria
Lead Sponsor:
Charles Drew University of Medicine and Science
Conditions:
Microalbuminuria
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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)progressio...
Detailed Description
Diabetic patients with confirmed MA (50-300 mg albumin per g creatinine) on a morning spot urine sample were entered into a one to three month run-in phase before randomization. (50 mg/g was used as t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00907374
Start Date
July 1 2005
End Date
April 1 2009
Last Update
March 30 2012
Active Locations (1)
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1
Charles Drew University
Los Angeles, California, United States, 90059