New onset juvenile sistemic lupus erythematosus nephritis MedDRA version: 6.1 Level: PT Classification code 10025140
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Azathioprine
CAS Number: 446-86-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical Form: Powder
Sponsors
ISTITUTO GIANNINA GASLINI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Newly diagnosed children with biopsy proven revised WHO Class III, IV proliferative lupus nephritis and 24 hour proteinuria 500 mg/day. The kidney biopsy specimen will be read by the renal pathologists of the participating centres light and immunofluorescence 54 . Slides of paraffin-embedded sections from all patients will be re-viewed by a blinded a renal pathologist at the PRINTO coordinating centre. 2 Diagnosis of JSLE according to the 1982 ACR classification criteria 57 ; 3 Age at enrolment 8804; 18 years. 4 Female of child-bearing potential must have a negative pregnancy test at the beginning of the trial, and then every 3 months. If sexually active, they must agree to use adequate contraception, throughout study participation, and must have no intention of conceiving during the course of the study. Post-pubertal males must have no plans to father a child during the study and agree to use adequate birth control methods if sexually active. 5 Duly executed, written, informed consent obtained from the parents or other legal representative and/or the patient according to requirement of the local ethics committee Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 Treatment with the CYC or AZA anytime before randomisation. 2 Neutrophil count 1,500 cell/mm3 and/or platelet count 50,000/mm3. 3 History of poor compliance with previous treatment. 4 Evidence of current use of alcohol or illicit drugs abuse. 5 Live vaccines not allowed during the entire duration of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effectiveness efficacy, safety, tolerability and compliance to treatment of 3 CYC regimens for the treatment of children with JSLE biopsy proven proliferative lupus glomerulonephritis;Secondary Objective: THE OVERALL HYPOTHESIS TO BE TESTED IN THIS JSLE TRIAL is to find out the relative effectiveness of 3 therapeutic schemes, i.e. the lowest effective and safest dose, and the shortest duration of treatment with CYC for the prevention of renal relapses while avoiding gonadal toxicity.;Primary end point(s): To assess the effectiveness efficacy, safety, tolerability and compliance to treatment of 3 CYC regimens for the treatment of children with JSLE biopsy proven proliferative lupus glomerulonephritis | — |
Countries
Belgium, Denmark, Italy
Outcome results
None listed