Maximizing the Benefit of Renin-Angiotensin Blocking Drugs in Diabetic Renal Disease. - Tabular View

Tracking Information

First Received Date ^ICMJE

October 13, 2005

Last Updated Date

October 16, 2006

Start Date ^ICMJE

December 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The amount of protein in the urine after 8 weeks of treatment.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00240019 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The estimated glomerular filtration rate after 8 weeks of treatment.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Maximizing the Benefit of Renin-Angiotensin Blocking Drugs in Diabetic Renal Disease.

Official Title ^ICMJE

Maximizing the Benefit of RAS Blockade in Diabetic Nephropathy

Brief Summary

The angiotensin converting enzyme inhibitor drugs are now standard therapy for patients with diabetic nephropathy. The hypothesis of this study is that adding a diuretic agent (furosemide) will decrease the urine protein, which is a sign of disease, more than an angiotensin converting enzyme inhibitor alone.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Diabetic Nephropathy

Intervention ^ICMJE

Drug: Addition of furosemide 20 mg oral bid to baseline regimen

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

proteinuria greater than 1 gram/day serum creatinine < 2.6 for men, < 2.0 for women

Exclusion Criteria:

blood pressure which cannot be controlled without a diuretic renal diseases other than diabetic nephropathy other disease which would alter renal function during 6 months

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00240019

Responsible Party

Study ID Numbers ^ICMJE

R01-063011, R01 DK063011

Study Sponsor ^ICMJE

Stanford University

Collaborators ^ICMJE

National Institutes of Health (NIH)

Investigators ^ICMJE

Principal Investigator:

Timothy W Meyer, MD

Stanford University

Information Provided By

Stanford University

Verification Date

June 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP