|- candidate number||2304|
|- NTR Number||NTR800|
|- Date ISRCTN created||1-dec-2006|
|- date ISRCTN requested||1-dec-2006|
|- Date Registered NTR||30-okt-2006|
|- Secondary IDs||N/A |
|- Public Title||Safety and efficacy of mycophenolate mofetil in pediatric renal transplantation.|
|- Scientific Title||Maintenance immunosuppression with mycophenolate mofetil and corticosteroids in pediatric kidney transplantation.|
|- hypothesis||1. MMF/Prednisolone is as efficacious in prevention of acute rejections as cyclosporine (CsA)/Pred; |
2. MMF/Prednisolone is safer than CsA/Pred, in renal function, lipids, and blood pressure.
|- Healt Condition(s) or Problem(s) studied||Renal transplant |
|- Inclusion criteria||All Dutch children, receiving a first kidney transplant after 01-01-2000, treated with initial immunosuppression corticosteroids, MMF and CsA, during the latter part of the study with addition of basiliximab.|
|- Exclusion criteria||1. Not on triple therapy (Pred/CsA/MMF) at the end of the 1st year;|
2. More than one acute rejection episode;
3. Rejection episode being not steroid sensitive;
4. No written informed consent.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2000|
|- planned closingdate||1-dec-2005|
|- Target number of participants||44|
|- Interventions||Start trial is one year after transplantation.|
Randomisation between 2 groups:
continuing with MMF/Pred or CsA/Pred by withdrawal over 3 months of the 3rd immunosuppressive drug. During the 3 months of withdrawal the Predniolone dosage is doubled. Follow-up is 2 years.
|- Primary outcome||1. Glomerular filtration rate;|
2. Incidence of acute rejections;
4. Bloodpressure and number of antihypertensive drugs.
|- Secondary outcome||1. Graft survival;|
2. Incidence of malignancies;
3. Incidence of viral infections;
4. Incidence of anemia.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| Karlien Cransberg|
|- CONTACT for SCIENTIFIC QUERIES|| Karlien Cransberg|
|- Sponsor/Initiator ||Erasmus Medical Center, Sophia Children's Hospital|
(Source(s) of Monetary or Material Support)
|Dutch Kidney Foundation (Nierstichting Nederland)|
|- Publications||Transplantation. 2007 Apr 27;83(8):1041-7.|
|- Brief summary||Mycophenolate mofetil (MMF) has gained a place in the immunosuppressive treatment of kidney transplantation, either added to a regimen of corticosteroids and cyclosporine, or replacing azathioprine in the triple regimen corticosteroids, cyclosporine and azathioprine. Its introduction has reduced the incidence of acute rejection episodes, both in adults and in children. Besides, it considerably improved short-term graft survival in children in the Netherlands. The side-effects are relatively mild, in the gastrointestinal system; it has no known negative effects on blood vessels or lipids. In contrast, cyclosporine (CsA) negatively affects the cardiovascular system and the kidneys: it causes vasoconstriction with elevation of blood pressure, nephrotoxicity, and corroborates the dyslipidemia caused by corticosteroids. Furthermore its use produces cosmetic changes, which may induce non-compliance, especially in adolescent girls. We felt it would be better, therefore, to restrict cyclosporine treatment to the first year after transplantation. This study aims at prospective assessment of the long-term safety and efficacy of MMF as an immunosuppressive drug in the maintenance phase of pediatric kidney transplantation as compared to cyclosporine, both in combination with corticosteroids. |
50 pediatric patients with a kidney graft, until the end of the 1st year treated with corticosteroids, MMF and CsA, with maximally 1 steroid sensitive acute rejection episode during the 1st year, are randomized to 2 groups: withdrawal of MMF or of CsA over 3 months. At the end of the 2nd and 3rd year after transplantation the following endpoints are compared between the groups: as primary endpoints the glomerular filtration rate and the number of acute rejection episodes, changes in serum lipids, blood pressure, and as secondary endpoints patient and graft survival, prevalence of anemia, incidence of infectious diseases and of malignancies.
|- Main changes (audit trail)|
|- RECORD||30-okt-2006 - 1-okt-2008|