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

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After two years of observation, steroids in the control group (branch B) can be withdrawn optionally in conformity with the same protocol as in branch A (uncontrolled second study phase).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.

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