Second Dutch Lupus Nephritis trial
| 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
Scientific
University Medical Centre Groningen
Department of Clinical Immunology
P.O. Box 30.001
Groningen
9700 RB
Netherlands
| Phone | +31 (0)50 3612945 |
|---|---|
| m.bijl@int.umcg.nl |
Study information
| Study design | Multicentre, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Comparison of short course cyclophosphamide followed by mycophenolate mofetil versus long course cyclophosphamide in the treatment of proliferative lupus nephritis |
| Study objectives | Short 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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2003 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 124 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Groningen
Groningen
9700 RB
Netherlands
9700 RB
Netherlands
Sponsor information
Sponsor not yet defined (The Netherlands)
Not defined
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)
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
