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

NCT00907374 | Completed Results DMC

• 2 other identifiers: IRB# 04-09-772U54RR014616
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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)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 \[CIMT\]).

Conditions

Microalbuminuria

Keywords

Microalbuminuria; Carotid intima media thickness; Endothelial dysfunction; Renin angiotensin system; Diabetic nephropathy

Outcome Measures

Primary Outcomes (1)

• Microalbuminuria Reported as Urinary Albumin:Creatinine Ratio

  Average of ratio for all participants during the 3-36 months of the study

  3 to 36 months

Secondary Outcomes (3)

• Estimated Glomerular Filtration Rate

  3 to 36 months

• Carotid Artery Intima Thickness

  6 to 36 months

• Endothelial Dysfunction

  6 to 36 months

Study Arms (2)

Low dose inhibition of RAS

ACTIVE COMPARATOR

Standard low dose inhibition of the RAS with 10 mg of benazepril orally daily to treat microalbuminuria

Drug: benazepril

Agressive inhibition of the RAS

EXPERIMENTAL

40-80 mg benazepril plus 25-100 mg losartan both orally once or twice daily

Drug: benazepril

Interventions

benazepril DRUG

benazepril 10 mg orally once daily

Also known as: Lotensin

Low dose inhibition of RAS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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.

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead

Study Sites (1)

Charles Drew University

Los Angeles, California, 90059, United States

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

benazepril; Losartan

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Results Point of Contact

• Title: Mayer B. Davidson, MD
• Organization: Charles R. Drew University

mayerdavidson@cdrewu.edu

323 357-3439

Study Officials

• Naureen Taureen, MD

  Charles Drew University

  PRINCIPAL INVESTIGATOR

• Mayer B. Davidson, MD

  Charles Drew University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: May 22, 2009
• Study Start: July 1, 2005
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: March 30, 2012
• Results First Posted: March 30, 2012

Record last verified: 2012-03

Locations

US (1)