Dettagli per singolo studio

DEC-NET Serial number IT447

Published online	20/07/2005 14.19.00
Last updated	06/09/2005 16.26.37

Other protocol ID number
Current trial status	Planned (i.e. not yet recruiting participants)
Major Disease (ICD9 class)	Nephritis and nephropathy, not specified as acute
Experimental drug
ramipril Treatment regimen (dosage and duration) N/A
irbesartan Treatment regimen (dosage and duration) N/A
Gender	Both
Age (range)	3-60 years
Eligibility criteria
Inclusion criteria
- Patients with diagnosis of primitive IgA nephropathy - Renal biopsy performed less than one year prior to randomization. - Proteinuria between 0,3 and 0,9 g/24 hours - Creatininemia less than 1,3 mg/dl in males and less than 1,2 mg/dl in females, with glomerular filtrate of at least 70 ml/min estimated (for children) with Schwartz.s formula - Arterial pressure (for children): less than 90th percentile for stature
Exclusion criteria
- undergoing ACE inhibitor or NSAID (non-steroidal antiinflammatory drug) therapy in previous 3 months - steroid or immunosuppressive drugs in previous 12 months - pregnancy - secondary forms of IgAN - Women of fertile age who do not take contraceptives - diabetes mellitus - renal diseases - HBSAg and HCVAb positivity - Infections - cancer
Trial design/methodology
Phase	3
Kind of study	Efficacy
Design	Controlled Randomised
Purpose of study
ACE inhibitors and angiotensin II receptor antagonists are drugs capable of reducing proteinuria. These are normally used, with success, in patients with proteinuria greater than 1 gram a day or in patients with arterial hypertension. We don.t know if these drugs, when given during the early (benign) phase of the disease, are capable of reducing the risk of disease progression to a more severe form. The aim of this study is to evaluate this possibility. The role of biochemical and genetic markers in predicting the nephropathy.s progression and the response to therapy with these drugs will also be evaluated.




Summary of study design, objectives, and ongoing research findings
The study foresees randomization of patients into three groups: the first will receive a small daily dose of ramipril (an ACE inhibitor), the second a small daily dose of irbesartan (an angiotensin II receptor antagonist), while the third will only undergo periodic controls to check the glomerulonephritis. progression (this is done routinely as part of daily clinical practice). All patients will be followed for at least 5 years. During the study, blood and urine samples will be collected to evaluated the renal disease.s progression from the start and the glomerulonephritis. progression over time in order to verify whether genetic or biochemical factors capable of allowing us to predict the glomerulonephritis. progression. If the disease should become more severe (arterial hypertension, proteinuria greater than 1 gram/day), the patient will be treated in the most appropriate and effective way to block the disease.s progression, as deemed appropriate by the physician.