Mycophenolate mofetil is effective in preventing relapses of the nephrotic syndrome and has less nephrotoxic effects compared to ciclosporine A.
ID
Bron
Verkorte titel
Aandoening
Children with frequent relapsing or corticoid dependent minimal change nephrotic syndrome.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
GFR.
Achtergrond van het onderzoek
Children 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.
Doel van het onderzoek
Mycophenolate mofetil is effective in preventing relapses of the nephrotic syndrome and has less nephrotoxic effects compared to ciclosporine A.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Randomisation for mycophenolate or ciclosporine A.
Publiek
P.O. Box 4220
E.M. Dorresteijn
Simon Smitweg 1
Leiderdorp 2350 CC
The Netherlands
+31 (0)71 5828282
Wetenschappelijk
P.O. Box 4220
E.M. Dorresteijn
Simon Smitweg 1
Leiderdorp 2350 CC
The Netherlands
+31 (0)71 5828282
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Children <18 years;
2. Minimal change nephrotic syndrome
GFR >80 ml/1.73m2/min;
3. Steroid dependency or frequent relapsing.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Severe anemia or leucopenia;
2. Active infection;
3. Failure of ciclosporine treatment in history.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL461 |
| NTR-old | NTR502 |
| Ander register | : N/A |
| ISRCTN | ISRCTN86423228 |