Skip to main content
OpenTrials
Completed

NCT Number: NCT00707759

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Kidney Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Calvo Mackenna Children Hospital

Santiago, Metropolitan Region, Chile

About this study

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 steroids in renal transplant and to compare with a steroid-based protocol.

Objectives:

  • To evaluate growth and the impairment in the GH/IGF (growth hormone/insulin like growth factor) axis
  • To determine the impact of steroids on bone metabolism (biochemical parameters, DXA and pQCT)
  • To determine the steroid effect on metabolic factors (dyslipidemia, insulin- sensitivity and arterial hypertension)
  • To determine acute rejection incidence (protocol renal biopsy)
  • To evaluate the expression of IL-17 and mRNA FoxP3 as early markers of acute rejection (blood, urine and renal biopsy).

Two treatment regimes (Arms)will be compared in randomized form in the course of 12 months after transplantation.

Arm A: TAC + MMF + withdrawal of steroids over a six-days following randomization.

Arm B: TAC + MMF + prednisolone (see schedule)/day

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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) + prednisolone

Drug

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

Primary outcomes

  1. Stimulation of Growth After 12 Months (Delta Z-score)

    Time frame: 12 months

Secondary outcomes

  1. Growth-factors (IGF-I, IGFBP-3) Bone Metabolism (FA, Ca/Cru, CaxP, 25(OH)VitD, FGF23, Klotho, PTH, DXA, pQCT) Insulin-sensitivity by ISI Method. Molecular Markers - Acute Rejection (FOXP3/IL-17). Acute Rejection Incidence/Protocol Renal Biopsy

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

Other Gov

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2014
First posted
Jul 1, 2008
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.