Overview

Steroid Withdrawal in Pediatric Renal Transplant: Impact on Growth, Bone Metabolism and Acute Rejection

Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Treatments:
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Mycophenolate mofetil
Mycophenolic Acid
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Prednisone
Tacrolimus
Criteria
Inclusion Criteria:

- Age < 16.0 years

- Bone age of boys < 15 years, of girls < 13 years

- Prepuberal Tanner Status I

- First or second kidney transplant, living or deceased kidney donation

- Immunosuppression with Tacrolimus (TAC),Mycophenolate mofetil (MMF)

- Patients and parents, respectively, have given their written consent after
enlightenment (informed consent)

Exclusion Criteria:

- Irreversible rejection of former transplant

- Highly reactive (> 30%) lymphocytotoxic antibodies within 12 months prior to
transplantation

- Suspected insufficient medication compliance in dialysis

- Patients receiving a basic immunosuppression other than that prescribed in this
protocol

- Simultaneous therapy with growth hormone after renal transplant