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Comparison of short course cyclophosphamide followed by mycophenolate mofetil versus long course cyclophosphamide in the treatment of proliferative lupus nephritis.


- candidate number1749
- NTR NumberNTR452
- ISRCTNISRCTN34634478
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR7-okt-2005
- Secondary IDsN/A 
- Public TitleComparison of short course cyclophosphamide followed by mycophenolate mofetil versus long course cyclophosphamide in the treatment of proliferative lupus nephritis.
- Scientific TitleSecond Dutch Lupus Nephritis trial.
- ACRONYMN/A
- hypothesisShort course cyclophosphamide followed by mycophenolate mofetil will reduce renal relapses to 33% (vs 10% in patients treated with long-course cyclophosphamide).
- Healt Condition(s) or Problem(s) studiedProliferative lupus nephritis
- Inclusion criteria1. Age 18 - 70 yrs; 2. SLE (presence of at least 4 ACR-criteria for SLE; 3. Proliferative lupus nephritis: a. Biopsy proven lupus nephritis WHO class III or IV (according to Churg 1995). and b. “Active sediment”. > 5 ery’s per HPF and/or celcylinders and c. Proteďnuria > 0.5 g/day; 4. Adequate anticonception; 5. Informed consent.
- Exclusion criteria1. Active infection; 2. Pregnancy; 3. Known allergy for one of the study drugs; 4. Malignancy < 5 years prior to inclusion.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blinding[default]
- control[default]
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-jan-2003
- planned closingdate
- Target number of participants124
- InterventionsCyclophosphamide, mycophenolate, prednisone.
- Primary outcomeNumber of renal relapses.
- Secondary outcome1. Longitudinal follow-up of creatinine, proteďnuria, sediment, complement levels, anti-dsDNA, SLEDAI, SLICC, Dutch lupus nephritis questionaire, SF-36, renal histology, IF-skin; 2. Extra-renale exacerbaties van de SLE; 3. Zwangerschap; 4. Overlijden.
- Timepoints
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. PhD. Marc Bijl
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Marc Bijl
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
Dutch Kidney Foundation (Nierstichting Nederland)
- PublicationsN/A
- Brief summaryPatients will be randomized between long-cyclophosphamide (6 monthly courses, 750 mg/m2) followed by either 6 3-monthly courses cyclophosphamide or mycophelolate mofetil, both regimes in combination with prednison. After 2 years all patients will continue for another 2 years with maintenance therapy, consisting of azathioprine 2 mg/kg
- Main changes (audit trail)
- RECORD7-okt-2005 - 13-nov-2008


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