Dettagli per singolo studio

DEC-NET Serial number IT448

Published online	20/07/2005 16.06.00
Last updated	08/09/2005 13.21.31

Other protocol ID number
Current trial status	Closed to recruitment of participants: follow-up continuing
Major Disease (ICD9 class)	Nephritis and nephropathy, not specified as acute
Experimental drug
benazepril Treatment regimen (dosage and duration) N/A
Gender	Both
Age (range)	3-35 years
Eligibility criteria
Inclusion criteria
Patients with dominant or co-dominant IgA mesangial deposits at renal biopsy will be eligible for the study if they will meet the criteria of Creatinine Clearance (CrCl) greater than 50 ml/min/1.73 m2 and proteinuria greater than 1g less than 3.5 g/1.73 m2/day in the 3 months before the enrolment. Patients normotensive or previously hypertensive in treatment with non ACE-I are eligible
Exclusion criteria
Secondary IgAN (Henoch-Schoenlein purpura, Lupus, Celiac disease, chronic liver or pulmonary diseases); any treatment with steroids, anti-inflammatory drugs, immunomodulators, cytostatic agents and ACE-I in the last 6 months before entering the trial (3 months before the run-in phase); renovascular hypertension; heart block;collagen vascular disease; diabetes; impaired hepatic function; history of angioneurotic edema or of hypersensitivity to ACE-I; leukopenia and significant haematological diseases; pregnancy or unwilling to use appropriate measures to avoid pregnancy during the study; likelihood of uncooperative attitude or poor compliance of parents or patient himself; uncontrolled arterial hypertension (these patients are included as soon as BP control is achieved by appropriate treatment with nifedipine and/or atenolol); need for treatment with diuretics because of edema; chronic cough
Trial design/methodology
Phase	3
Kind of study	Efficacy
Design	Controlled Randomised Blinded Double blind
Purpose of study
To determine the therapeutic potential on the progression to renal failure of ACE-I in young patients with IgA nephropathy




Summary of study design, objectives, and ongoing research findings
This will be a randomized, double-blind, placebo-controlled, prospective, multicenter clinical trial evaluating the effect of ACE-I (benazepril 0.2 mg/Kg/Day) in children and young adults with IgAN who are at risk of progression to renal failure. The primary objective is to assess the effects on the decline of glomerular filtration rate (GFR). Secondary objectives are to assess the effect on proteinuria and the clinical and histological features of patients responsive to this treatment . The study consists of a three month run-in phase to make sure that the patients constantly accomplish the entering criteria and to lower blood pressure (BP) into the normal range if necessary. Then, the patients will be randomized either to ACE-I or placebo group and enter the trial. Follow-up lasts 5 years.