CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 28 enrolled
Drug / intervention
Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone +1 moredrug
Likely dose
Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone 3 mg/kgfrom record
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Search/NCT00707759
NCT00707759Phase 3Completed
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Multicenter, Open-Label, Randomized Study on Steroid-Free Immunosuppression, in Comparison With Daily Steroid Therapy, in Pediatric Renal Transplant : Impact on Growth, Bone Metabolism and Acute Rejection

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile·interventional·Posted Jul 1, 2008·Updated Nov 10, 2015

In Brief

A Phase 3 clinical trial evaluating Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone and Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone for Kidney Diseases. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Diseases
CountriesChile
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 1, 2008
Enrollment StartJun 1, 2008
Primary CompletionDec 1, 2012
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 18.0 years ago

Interventions

Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisonedrug

Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization. 1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses 2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses 3°day: Prednisone 2 mg/kg/d in 2 doses 4ºday: Prednisone 1 mg/kg/d in 2 doses 5ºday: Prednisone 0.5 mg/kg/d in 2 doses 6ºday: Prednisone 0.25 mg/kg/d in 2 doses 7ºday: Stop Prednisone

Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolonedrug

Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day 10°days after Tx: 2 mg/kg/d Day 11 - 20: 1 mg/kg/d Day 21 - 30: 0.5 mg/kg/d Day 31 - 60: 0.3 mg/k/d Week 8 - 12: 0.25 mg/k/d Week 12 - 16: 0.20 mg/k/d Week 16 - 20: 0.15 mg/k/d Month 6 - 12: 0.10 - 0.12 mg/k/d