Steroid Withdrawal in Pediatric Renal Transplant: Impact on Growth, Bone Metabolism and Acute Rejection
Summary
The present study investigates the safety and efficacy of steroid withdrawal at six days post-transplant in pediatric renal recipients under concomitant immunosuppression based on antibodies anti IL2 (interleukin 2), Tacrolimus (TAC) and Mycophenolate Mofetil (MMF). To investigate the impact of this protocol in growth, bone metabolism, insulin- sensitivity and evaluate the expression of IL17 (interleukin 17) and mRNA FOXP3 (messenger ribonucleic acid forkhead box protein 3) as early markers of acute rejection (blood, urine and renal biopsy). Hypothesis:Steroid withdrawal in renal pediatric transplant patients improves growth and bone metabolism without increasing the risk of acute rejection. The expression of FoxP3/IL17 in urine cells could be an early molecular markers of acute rejection.
Timeline
- Start
- 2008-06
- Primary completion
- 2012-12
- Completion
- 2014-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylprednisolone | Other / unclassified | 2 mg/kg | Intravenous |
| Subject | Methylprednisolone | Other / unclassified | 3 mg/kg | Intravenous |
| Comparator | Prednisolone | Other / unclassified | 0.1 mg/kg | — |
| Comparator | Prednisolone | Other / unclassified | 0.12 mg/kg | — |
| Subject | Prednisone | Other / unclassified | — | — |
| Background | Mycophenolate Mofetil | Small molecule | — | — |
| Background | Tacrolimus | Small molecule | — | — |