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

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Klinik für Kinder- und Jugendmedizin
• Collaborator: Hoffmann-La Roche
• Treatments: Cyclosporine; Cyclosporins; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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