Comparison of Immunosuppression Protocols After LTx in Children
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
Timeline
- Start
- 2002-09
- Primary completion
- —
- Completion
- 2006-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycophenolate Mofetil | Small molecule | 30 mg/kg | Oral |
| Subject | Prednisone | Other / unclassified | 0.1 mg/kg | — |
| Background | Metylprednisolon | Unknown | 10 mg/kg | Intravenous |
| Background | Tacrolimus | Small molecule | 0.15 mg/kg | Oral |
Indications
No indication recorded.