Glomerulonephritis
Conditions
Brief summary
To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA nephropathy.
Interventions
DRUGRamipril
2.5mg and increase to 5mg if patient do not develop symptomatic hypotension
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development of hypertension (defined as blood pressure above 140/90 mm Hg and require anti-hypertensive therapy) | From the beginning to the end of the study |
| Development of proteinuria | From the beginning to the end of the study |
| 20% decline in creatinine clearance, as determined by 24-hour urine collection or estimated by the Gault-Cockroft equation | From the beginning to the end of the study |
| body weight, blood pressure, pulse | From the beginning to the end of the study |
| Adverse effects of treatment | From the beginning to the end of the study |
Countries
Hong Kong
Outcome results
None listed