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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01225445
• Date of registration: 20/10/2010
• Prospective Registration: No
• Primary sponsor: Chinese University of Hong Kong
• Public title: Treatment of Early Immunoglobulin A Nephropathy by Angiotensin Converting Enzyme Inhibitor - A Randomized Controlled Trial
• Scientific title: Treatment of Early Immunoglobulin A Nephropathy by Angiotensin Converting Enzyme Inhibitor - A Randomized Controlled Trial
• Date of first enrolment: April 2002
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01225445
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Hong Kong

Contacts

• Name: Cheuk Chun Szeto, MD
• Affiliation: Chinese University of Hong Kong

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 umol/l

- willingness to give written informed consent and willingness to participate in and
comply with the study protocol

Exclusion Criteria:

- expected survival less than 2 years

- 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

- history of non-compliance to medical regimens and patients who are considered
potentially unreliable

- known history of sensitivity / allergy to ACE inhibitor



Age minimum: 18 Years
Age maximum: 25 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Proteinuria Less Than 0.5 g Per Day

Normal Blood Pressure

Biopsy-confirmed IgA Nephropathy

Serum Creatinine Below 120 Umol/l

Intervention(s)

Drug: Ramipril

Primary Outcome(s)

blood pressure [Time Frame: 5 years]

serum creatinine [Time Frame: 5 years]

proteinuria [Time Frame: 5 years]

Secondary ID(s)

HOE 498/6015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors