Status:
COMPLETED
Steroid Withdrawal in Pediatric Renal Transplant: Impact on Growth, Bone Metabolism and Acute Rejection
Lead Sponsor:
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Conditions:
Kidney Diseases
Eligibility:
All Genders
1-16 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
The intention of this investigation is to evaluate a prospective immunosuppressive protocol based on antibodies anti IL-2 (Ac-IL-2), Tacrolimus (TAC) and Mycophenolate Mofetil (MMF)and withdrawal ster...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00707759
Start Date
June 1 2008
End Date
December 1 2014
Last Update
November 10 2015
Active Locations (1)
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1
Calvo Mackenna Children Hospital
Santiago, Metropolitan Region, Chile