Contact information
Type
Scientific
Primary contact
Dr Marc Bijl
ORCID ID
Contact details
University Medical Centre Groningen
Department of Clinical Immunology
P.O. Box 30.001
Groningen
9700 RB
Netherlands
+31 (0)50 3612945
m.bijl@int.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR452
Study information
Scientific title
Comparison of short course cyclophosphamide followed by mycophenolate mofetil versus long course cyclophosphamide in the treatment of proliferative lupus nephritis
Acronym
Study hypothesis
Short course cyclophosphamide followed by mycophenolate mofetil will reduce renal relapses to 33% (versus 10% in patients treated with long-course cyclophosphamide)
Ethics approval
Received from the local medical ethics committee
Study design
Multicentre, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Proliferative lupus nephritis
Intervention
Patients 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 type
Drug
Phase
Not Specified
Drug names
Cyclophosphamide, mycophenolate mofetil
Primary outcome measure
Number of renal relapses
Secondary outcome measures
1. 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 trial start date
01/01/2003
Overall trial end date
01/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
124
Participant exclusion criteria
1. Active infection
2. Pregnancy
3. Known allergy for one of the study drugs
4. Malignancy less than 5 years prior to inclusion
Recruitment start date
01/01/2003
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Centre Groningen
Groningen
9700 RB
Netherlands
Funders
Funder type
Research organisation
Funder name
Dutch Kidney Foundation (Nierstichting Nederland) (The Netherlands)
Alternative name(s)
Dutch Kidney Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list