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van CCT (UK)


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van CCT (UK)


Randomised multi-centre study comparing mycophenolate and ciclospoine A in children with a frequent relapsing or corticoid dependent idiopathic nephrotic syndrome.


- candidate number1824
- NTR NumberNTR502
- ISRCTNISRCTN86423228
- Date ISRCTN created14-feb-2006
- date ISRCTN requested13-jan-2006
- Date Registered NTR10-nov-2005
- Secondary IDsN/A 
- Public TitleRandomised multi-centre study comparing mycophenolate and ciclospoine A in children with a frequent relapsing or corticoid dependent idiopathic nephrotic syndrome.
- Scientific TitleMycophenolate in children with an idiopatic nephrotic syndrome.
- ACRONYMN/A
- hypothesisMycophenolate mofetil is effective in preventing relapses of the nephrotic syndrome and has less nephrotoxic effects compared to ciclosporine A.
- Healt Condition(s) or Problem(s) studiedNephrotic syndrome
- Inclusion criteria1. Children <18 years;
2. Minimal change nephrotic syndrome GFR >80 ml/1.73m2/min;
3. Steroid dependency or frequent relapsing.
- Exclusion criteria1. Severe anemia or leucopenia;
2. Active infection;
3. Failure of ciclosporine treatment in history.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2002
- planned closingdate1-jun-2005
- Target number of participants31
- InterventionsRandomisation for mycophenolate or ciclosporine A.
- Primary outcomeGFR.
- Secondary outcome1. Relapse rate;
2. Other adverse effects.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. E.M. Dorresteijn
- CONTACT for SCIENTIFIC QUERIESDr. E.M. Dorresteijn
- Sponsor/Initiator Rijnland Hospital
- Funding
(Source(s) of Monetary or Material Support)
Roche Nederland BV, Erasmus Medical Center, Department of Pediatric nephrology
- PublicationsPediatr Nephrol. 2008 Jul 12. [Epub ahead of print]
- Brief summaryChildren with frequently relapsing or steroid dependent nephrotic syndrome are currently treated with dialy ciclosporine. Because of serious side effects of ciclosporine, as nephrotoxicity and hypertension, an alternative treatment is investigated. To compare the efficacy and safety of mycophenolate mofetil in these children, we randomise children <17 years, with frequently relapsing or steroid dependent minimal change nephrotic syndrome, for daily treatment with ciclosporine (5mg/kg/day) or mycophenolate mofetil (1200mg/m2/day) during 1 year. Side effects and number of relapses of the nephrotic syndrome are compared between the two groups.
- Main changes (audit trail)
- RECORD10-nov-2005 - 14-aug-2008


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