Comparison of Immunosuppression Protocols After LTx in Children
Status:
Completed
Trial end date:
2006-07-01
Target enrollment:
Participant gender:
Summary
Open label, randomised, prospective, onecentre Investigator Driven Study:
Comparison of two protocols of immunosuppression after liver Tx in children:
A: Study group - FK506-MMF. Immunosupression protocol: Methylprednisolone 10 mg/kg
intraoperatively i.v. FK506 Day 0 or 1 orally (0,15 mg/kg/D in two doses).MMF max. dosage 30
mg/kg/D p.o. day 0 through day 90.
B. Control group - Tacrolimus, steroids. Immunosupression protocol: Methylprednisolone 10
mg/kg bm intraoperatively Children < 25kg bm: Methylprednisolone taper from 100 mg/D on day 0
to MP 10 mg on day 7 Children > 25kg bm: Methylprednisolone taper from 200 mg/D on day 0 to
MP 20 mg on day 7 Week 2-4 Prednisone - 0,5-0,3 mg/kg/D; Week 4-12 Prednisone -0,3-0,2
mg/kg/D; Month 4-6 Prednisone 0,2 - 0,1 mg/kg/D Month 7 - Steroid withdrawal FK506 Day 0 or 1
orally (0,15 mg/kg/D in two doses).
Primary end points:
Number of rejections, number of steroid-resistant rejections.
Secondary end points:
Patients and graft survival Dyslipidemia one year after transplantation Hypertension one year
after transplantation Hyperglycemia/Diabetes de novo one year after transplantation Renal
function before Tx and 1 year after Tx