ISRCTN ISRCTN34634478
DOI https://doi.org/10.1186/ISRCTN34634478
Secondary identifying numbers NTR452
Submission date
27/01/2006
Registration date
27/01/2006
Last edited
13/11/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Marc Bijl
Scientific

University Medical Centre Groningen
Department of Clinical Immunology
P.O. Box 30.001
Groningen
9700 RB
Netherlands

Phone +31 (0)50 3612945
Email m.bijl@int.umcg.nl

Study information

Study designMulticentre, randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleComparison of short course cyclophosphamide followed by mycophenolate mofetil versus long course cyclophosphamide in the treatment of proliferative lupus nephritis
Study objectivesShort course cyclophosphamide followed by mycophenolate mofetil will reduce renal relapses to 33% (versus 10% in patients treated with long-course cyclophosphamide)
Ethics approval(s)Received from the local medical ethics committee
Health condition(s) or problem(s) studiedProliferative lupus nephritis
InterventionPatients will be randomised between long-cyclophosphamide (six monthly courses, 750 mg/m^2) followed by either six 3-monthly courses cyclophosphamide or mycophelolate mofetil, both regimes in combination with prednisone. After 2 years all patients will continue for another 2 years with maintenance therapy, consisting of azathioprine 2 mg/kg.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Cyclophosphamide, mycophenolate mofetil
Primary outcome measureNumber of renal relapses
Secondary outcome measures1. Longitudinal follow-up of creatinine, proteinuria, sediment, complement levels, anti-double stranded deoxyribonucleic acid (anti-dsDNA), Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), Systemic Lupus International Collaborating Clinics (SLICC), Dutch lupus nephritis questionnaire, 36-item short form health survey (SF-36), renal histology, IF-skin
2. Extra-renal exacerbations of SLE
3. Pregnancy
4. Death
Overall study start date01/01/2003
Completion date01/01/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants124
Key inclusion criteria1. Aged 18 - 70 years
2. Systemic lupus erythematosus (SLE) (presence of at least 4 American College of Rheumatology [ACR]-criteria for SLE)
3. Proliferative lupus nephritis:
3.1. Biopsy proven lupus nephritis World Health Organization (WHO) class III or IV (according to Churg 1995)
3.2. 'Active sediment': greater than 5 erythrocytes per high powered field (HPF) and/or cel cylinders
3.3. Proteinuria greater than 0.5 g/day
4. Adequate contraception
5. Informed consent
Key exclusion criteria1. Active infection
2. Pregnancy
3. Known allergy for one of the study drugs
4. Malignancy less than 5 years prior to inclusion
Date of first enrolment01/01/2003
Date of final enrolment01/01/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Centre Groningen
Groningen
9700 RB
Netherlands

Sponsor information

Sponsor not yet defined (The Netherlands)
Not defined

-
-
-
Netherlands

Funders

Funder type

Research organisation

Dutch Kidney Foundation (Nierstichting Nederland) (The Netherlands)
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Dutch Kidney Foundation
Location
Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan