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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 22 April 2013
Main ID:  EUCTR2005-003957-28-DK
Date of registration: 20/11/2006
Prospective Registration: Yes
Primary sponsor: Istituto Giannina Gaslini
Public title: FIVE-YEAR SINGLE-BLIND, PHASE III EFFECTIVENESS RANDOMISED ACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILE SYSTEMIC LUPUS ERYTHEMATOSUS NEPHRITIS: ORAL CYCLOPHOSPHAMIDE VERSUS HIGH DOSE INTRAVENOUS CYCLOPHOSPHAMIDE VERSUS INTERMEDIATE DOSE INTRAVENOUS CYCLOPHOSPHAMIDE
Scientific title: FIVE-YEAR SINGLE-BLIND, PHASE III EFFECTIVENESS RANDOMISED ACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILE SYSTEMIC LUPUS ERYTHEMATOSUS NEPHRITIS: ORAL CYCLOPHOSPHAMIDE VERSUS HIGH DOSE INTRAVENOUS CYCLOPHOSPHAMIDE VERSUS INTERMEDIATE DOSE INTRAVENOUS CYCLOPHOSPHAMIDE
Date of first enrolment: 21/12/2006
Target sample size: 141
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-003957-28
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: yes Other trial design description: same drug at different dosage If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: same drug at different dosage  
Phase: 
Countries of recruitment
Denmark Italy
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
1)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.
2) Diagnosis of JSLE according to the ACR revised classification criteria (57);
3) Age at enrolment = 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) 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
6)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:
1) Treatment with the CYC, AZA or mycophenolate mofetil 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
SYSTEMIC LUPUS ERYTHEMATOSUS NEPHRITIS
MedDRA version: 8.1 Level: LLT Classification code 10029142 Term: Nephritis systemic lupus erythematosus
Intervention(s)

Product Name: Cyclophosphamide
Pharmaceutical Form: Tablet
CAS Number: 6055-19-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Name: Cyclophosphamide
Pharmaceutical Form: Powder for solution for infusion
CAS Number: 6055-19-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-

Primary Outcome(s)
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 (revised version of the World Health Organisation [WHO] class III, IV)
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 (revised version of the World Health Organisation [WHO] class III, IV)
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.
Secondary Outcome(s)
Secondary ID(s)
2005-003957-28-IT
IGG-PRINTO-003
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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