Treatment of Immunoglobulin A (IgA) Nephropathy by Angiotensin-Converting Enzyme (ACE) Inhibitor - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00437463

Purpose

To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA nephropathy.

Condition	Intervention	Phase
Glomerulonephritis	Drug: Ramipril	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Treatment of Early Immunoglobulin A Nephropathy by ACE Inhibitor - a Randomized Controlled Trial

Resource links provided by NLM:

Drug Information available for: Ramipril Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Development of hypertension (defined as blood pressure above 140/90 mm Hg and require anti-hypertensive therapy) [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
Development of proteinuria [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
20% decline in creatinine clearance, as determined by 24-hour urine collection or estimated by the Gault-Cockroft equation [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
body weight, blood pressure, pulse [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
Adverse effects of treatment [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	July 2004
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Ramipril	Drug: Ramipril 2.5mg and increase to 5mg if patient do not develop symptomatic hypotension
2: No Intervention

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

biopsy-confirmed IgA nephropathy
proteinuria less than 0.5 g per day, normal blood pressure, and serum creatinine below 120 µmol/l

Exclusion Criteria:

pregnant or nursing mother, or women of childbearing potential without an effective method of birth control
history of myocardial infarction, congestive heart failure, or any other medical indication that necessitate the use of ACE inhibitor
evidence of clinically significant hepatic, gastrointestinal, autoimmune disease
history of malignancy, drug or alcohol abuse
participation in any previous trial on ACE inhibitor
taking other investigational drugs within the past 30 days
known history of sensitivity / allergy to ACE inhibitor

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437463

Locations

Hong Kong
Sanofi-aventis
Hong Kong, Hong Kong

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Daniel Yuen

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	HOE498_6015
Study First Received:	February 20, 2007
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00437463 History of Changes
Health Authority:	Hong Kong: Department of Health

Additional relevant MeSH terms:

Glomerulonephritis
Autoimmune Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

Immunoglobulin A
Antibodies
Urologic Diseases
Nephritis
Glomerulonephritis, IGA
Angiotensin-Converting Enzyme Inhibitors
Kidney Diseases
Immunoglobulins

ClinicalTrials.gov processed this record on February 04, 2010