Five-Year Actively Controlled Clinical Trial in New Onset Juvenile Systemic Lupus Erythematosus Nephritis

• Status: Withdrawn
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 5-year project, involving 185 partners from 46 countries (110 in 21 EU States and 75 in 25 extra-EU States), with a randomised clinical trials (RCT) in juvenile systemic lupus erythematosus (JSLE): 5-year phase III single-blind, RCT in children with newly diagnosed, WHO class III, IV JSLE proliferative nephritis: PDN and oral cyclophosphamide (CYC) versus high dose intravenous (iv) CYC versus intermediate dose iv CYC, followed by maintenance with azathioprine.The trial is aimed to find out the treatment regimen associated with the lowest occurrence of flare and the lowest drug related toxicity.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Giannina Gaslini
• Treatments: Azathioprine; Cyclophosphamide; Prednisone

Criteria

Inclusion Criteria:

Newly diagnosed children with untreated and 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.

Diagnosis of JSLE according to the ACR revised classification criteria (57); Age at enrolment ≤ 18 years. 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.

Ability to comply with the entire study procedures, ability to communicate meaningfully with the investigational staff, competence to give written informed consent; to be applied to the parents and/or patients, as appropriate 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.

Exclusion Criteria:

Treatment with the CYC, AZA or mycophenolate mofetil anytime before randomisation.

Neutrophil count <1,500 cell/mm3 and/or platelet count <50,000/mm3. History of poor compliance with previous treatment. Evidence of current use of alcohol or illicit drugs abuse. Live vaccines not allowed during the entire duration of the trial.