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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00212901

First Posted: September 21, 2005

Last Update Posted: July 26, 2007

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Ottawa Hospital Research Institute

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label)
Official Title:	Addition of Angiotensin Receptor Blockade to ACE Inhibition Versus High Dose ACE Inhibition for Reduction of Proteinuria in Patients With Diabetic Nephropathy

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Kidney Problems Kidney Diseases

U.S. FDA Resources

Further study details as provided by Ottawa Hospital 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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

Exclusion Criteria:

Creatinine clearance <50ml/min or 24hour protein excretion >3gm/d.
Hypotension as defined by the inability to add an ARB or increase ACE-I dose secondary to hypotensive symptomatology or a systolic Bp <100mmHg.
Serum potassium >5.5 on two separate occasions in the previous six months
Previous adverse reaction to angiotensin receptor antagonist medication
Use of NSAIDS including COX2 inhibitors
Pregnant or nursing women will be excluded
Currently taking an angiotensin receptor antagonist

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212901

Locations


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

Sponsors and Collaborators

Ottawa Hospital Research Institute

Investigators


Principal Investigator:	Ayub Akbari, MD	OHRI

More Information


ClinicalTrials.gov Identifier:	NCT00212901 History of Changes
Other Study ID Numbers:	2004482-01
First Submitted:	September 13, 2005
First Posted:	September 21, 2005
Last Update Posted:	July 26, 2007
Last Verified:	July 2007

Keywords provided by Ottawa Hospital Research Institute:


Diabetes Proteinuria Angiotensin converting enzyme inhibitors Angiotensin receptor antagonists

Additional relevant MeSH terms:


Kidney Diseases Diabetic Nephropathies Urologic Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases	Angiotensin-Converting Enzyme Inhibitors Angiotensin Receptor Antagonists Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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