Phase 3 N=28 Randomized Treatment

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

Kidney Diseases

Bottom Line

View on ClinicalTrials.gov: NCT00707759 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2015

Primary outcome: Primary: Stimulation of Growth After 12 Months (Delta Z-score) — 1.2; 0.6 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone (Drug); Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (Drug)
Age: Pediatric · 1+ yrs
Sex: All
Sponsor: Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Stimulation of Growth After 12 Months (Delta Z-score)	1.2; 0.6	—
SECONDARY 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	—	—

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.

Eligibility Criteria

Inclusion Criteria

Age 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

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Data sourced from ClinicalTrials.gov (NCT00707759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.