Steroid Withdrawal in Pediatric Renal Transplant Recipients Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF)

Klinik für Kinder- und Jugendmedizin42 enrolled

Overview

The present study investigates the safety and efficacy of steroid withdrawal in pediatric renal transplant recipients with stable graft function under concomitant immunosuppression with cyclosporine and mycophenolate mofetil.

The present protocol aims to investigate the steroid-saving potential of MMF in pediatric patients after NTx. Over a 2-year period, two treatment regimes will be compared in randomized form in patients with a stable renal transplant function in the course of 12 - 24 months after transplantation (controlled first study phase): Branch A: CyA + MMF + withdrawal of steroids over a three-month period following randomization Branch B: CyA + MMF + 4 mg/m² methylprednisolone (or prednisolone equivalent)/day After two years of observation, steroids in the control group (branch B) can be withdrawn optionally in conformity with the same protocol as in branch A (uncontrolled second study phase). It is to be expected that part of the patients will decide in favour of a withdrawal of steroids. In the uncontrolled second study phase, a comparison will thus be drawn among three therapy groups over a period of another 15 months (altogether 3.5 years beginning with randomization), in order to throw some light on the medium-term effect of steroid-free immunosuppression on length growth and transplant function.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Kidney Diseases

Interventions

methylprednisoloneDRUG

withdrawal of methylprednisolone in arm A and continuous Steroid Treatment in arm B

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \< 18.0 years * Bone age of boys \< 15 years, of girls \< 13 years * Patients 12-24 months after renal transplantation with stable transplant function * First or second kidney transplant, living or cadaver kidney donation * Triple immunosuppression with cyclosporine (CyA), MMF, and daily steroids at study entry * Patients and parents, respectively, have given their written consent after enlightenment (informed consent) Exclusion Criteria: * Irreversible rejection of former transplant within 6 months * Highly reactive (\> 80%) lymphocytotoxic antibodies within 12 months prior to transplantation * Anamnestically steroid-resistant rejection of current transplant * More than 2 acute rejection reactions prior to study entry (i.e., in the first 12-24 months after kidney transplantation) or 1 acute rejection reaction during the last 6 months before study entry * Glomerular filtration rate (GFR) \< 40 ml/min/1.73 m² (Schwartz formula) at study entry * Acute rejection reaction or unstable transplant function (increase of serum creatinine \> 20%) during the last 6 months before study entry or histologically confirmed chronic rejection reaction * Suspected insufficient medication compliance * Patients receiving a basic immunosuppression other than that prescribed in this protocol * Simultaneous therapy with growth hormone after renal transplantation

Locations (1)

University Children's Hospital

Heidelberg, Germany

Outcomes

Primary Outcomes

Stimulation of length growth after 24 months (controlled study phase) and 36 months (uncontrolled study phase)

Time frame: 24 months

Secondary Outcomes

Number of patients who were deprived of steroids successfully

Time frame: 24 months

Transplant survival and function after 24 (controlled) and 36 (uncontrolled) months

Time frame: 24 months

Incidence and severity of steroid side effects

Time frame: 24 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.