No registrations found.
ID
Source
Brief title
Health condition
Children with frequent relapsing or corticoid dependent minimal change nephrotic syndrome.
Sponsors and support
Intervention
Outcome measures
Primary outcome
GFR.
Secondary outcome
1. Relapse rate;
2. Other adverse effects.
Background summary
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.
Study objective
Mycophenolate mofetil is effective in preventing relapses of the nephrotic syndrome and has less nephrotoxic effects compared to ciclosporine A.
Study design
N/A
Intervention
Randomisation for mycophenolate or ciclosporine A.
P.O. Box 4220
E.M. Dorresteijn
Simon Smitweg 1
Leiderdorp 2350 CC
The Netherlands
+31 (0)71 5828282
P.O. Box 4220
E.M. Dorresteijn
Simon Smitweg 1
Leiderdorp 2350 CC
The Netherlands
+31 (0)71 5828282
Inclusion criteria
1. Children <18 years;
2. Minimal change nephrotic syndrome
GFR >80 ml/1.73m2/min;
3. Steroid dependency or frequent relapsing.
Exclusion criteria
1. Severe anemia or leucopenia;
2. Active infection;
3. Failure of ciclosporine treatment in history.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL461 |
| NTR-old | NTR502 |
| Other | : N/A |
| ISRCTN | ISRCTN86423228 |