High Dose Ace Inhibitor Therapy Versus Combination of ACE and ARB Therapy

This study has been completed.

First Received: September 13, 2005 Last Updated: July 25, 2007 History of Changes

Sponsored by:	Ottawa Health Research Institute
Information provided by:	Ottawa Health Research Institute
ClinicalTrials.gov Identifier:	NCT00212901

Purpose

Investigation of wheather addition of angiotensin receptor blocker (Irbesartan) to recommended doses of angiotensin converting enzyme inhibitor (trandolapril) is more effective in decreasing amount of protein in urine in patients with diabetic kidney disease than high doses of trandolapril.

Condition	Intervention
Diabetic Kidney Disease	Drug: High dose ACE-I vs ARB

MedlinePlus related topics: Diabetic Kidney Problems

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Addition of Angiotensin Receptor Blockade to ACE Inhibition Versus High Dose ACE Inhibition for Reduction of Proteinuria in Patients With Diabetic Nephropathy

Further study details as provided by Ottawa Health Research Institute:

Primary Outcome Measures:

reducing proteinuria

Secondary Outcome Measures:

glomerular filtration rate
side-effects of hypotension, postural symptom

Estimated Enrollment:	30
Study Start Date:	August 2004
Study Completion Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Early diabetic nephropathy as defined by proteinuria between 500mg/24hr and 3g/24hr and GFR>50ml/min (as calculated by the Cockcroft-Gault formula), in the absence of clinical and laboratory evidence of other non-diabetic renal disease.
Controlled blood pressure (<150/<90)
Able to give informed consent
Between the ages of 18 and 75
Must be capable of providing a 24 hour urine collection
Negative BHcG test for ruling out pregnancy in women of childbearing age
Currently taking an angiotensin converting enzyme inhibitor

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Exclusion Criteria:

1] Creatinine clearance <50ml/min or 24hour protein excretion >3gm/d. 2] Hypotension as defined by the inability to add an ARB or increase ACE-I dose secondary to hypotensive symptomatology or a systolic Bp

lt;100mmHg. 3] Serum potassium >5.5 on two separate occasions in the previous six months 4] Previous adverse reaction to angiotensin receptor antagonist medication 5] Use of NSAIDS including COX2 inhibitors 6] Pregnant or nursing women will be excluded 7] Currently taking an angiotensin receptor antagonist

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212901

Locations

Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 7W9

Sponsors and Collaborators

Ottawa Health Research Institute

Investigators

Principal Investigator:

Ayub Akbari, MD

OHRI

More Information

No publications provided

Study ID Numbers:	2004482-01
Study First Received:	September 13, 2005
Last Updated:	July 25, 2007
ClinicalTrials.gov Identifier:	NCT00212901 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Ottawa Health Research Institute:

Diabetes
Proteinuria
Angiotensin converting enzyme inhibitors
Angiotensin receptor antagonists

Study placed in the following topic categories:

Proteinuria
Diabetic Nephropathies
Urologic Diseases
Diabetes Mellitus
Angiotensin-Converting Enzyme Inhibitors

Endocrine System Diseases
Endocrinopathy
Kidney Diseases
Diabetes Complications
Protease Inhibitors

Additional relevant MeSH terms:

Diabetic Nephropathies
Molecular Mechanisms of Pharmacological Action
Urologic Diseases
Diabetes Mellitus
Angiotensin-Converting Enzyme Inhibitors
Endocrine System Diseases

Enzyme Inhibitors
Kidney Diseases
Pharmacologic Actions
Diabetes Complications
Protease Inhibitors

ClinicalTrials.gov processed this record on May 07, 2009