Treatment of Early Immunoglobulin A Nephropathy by the Angiotensin Converting Enzyme Inhibitor Ramipril - A Randomized Controlled Trial

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-TRC-09000630
• Date of registration: 2005-09-06
• Prospective Registration: No
• Primary sponsor: The Chinese University of Hong Kong
• Public title: Treatment of Early Immunoglobulin A Nephropathy by the Angiotensin Converting Enzyme Inhibitor Ramipril - A Randomized Controlled Trial
• Scientific title: Treatment of Early Immunoglobulin A Nephropathy by the Angiotensin Converting Enzyme Inhibitor Ramipril - A Randomized Controlled Trial
• Date of first enrolment: 2004-01-01
• Target sample size: Two groups:60;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=8905
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Other

Countries of recruitment

China

Contacts

• Name: Dr. SZETO Cheuk Chun

• Name: Dr. SZETO Cheuk Chun
• Affiliation: Department of Medicine & Therapeutics, CUHK

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria are: ? age between 18 and 65 ? biopsy-confirmed IgA nephropathy ? proteinuria less than 0.5 g per day, normal blood pressure, and serum creatinine below 120 mol/l ? willingness to give written informed consent and willingness to participate in and comply with the study protocol
Exclusion criteria: Exclusion criteria are:
1. expected survival less than 2 years;
2. pregnant or nursing mother, or women of childbearing potential without an effective method of birth control;
3. 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;
4. history of malignancy, drug or alcohol abuse;
5. participation in any previous trial on ACE inhibitor;
6. taking other investigational drugs within the past 30 days;
7. history of non-compliance to medical regimens and patients who are considered potentially unreliable ? known history of sensitivity / allergy to ACE inhibitor

Age minimum: 0
Age maximum: 0
Gender: Male

Health Condition(s) or Problem(s) studied

IgA nephropathy

Intervention(s)

Two groups:ramipril 5 years versus no treatment;

Primary Outcome(s)

development of hypertension (defined as blood pressure above 140/90 mm Hg and require anti-hypertensive therapy);development of proteinuria ?d 1 g per day;20% decline in creatinine clearance, as determined by 24-hour urine collection or estimated by the Gault-Cockroft equation;

Secondary ID(s)

CUHK_CCT00027

Source(s) of Monetary Support

The Chinese University of Hong Kong