NCT00309218

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

Multicenter, Open-label, Randomized Study on Steroid-free Immunosuppression, in Comparison With Daily Steroid Therapy, in Children With Stable Renal Transplant Function Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Klinik für Kinder- und Jugendmedizin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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(or prednisolone equivalent)/day After two years of observation, steroids in the control group (branch B) can be withdrawn optionally in conformity with the same protocol as in branch A (uncontrolled second study phase).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

Conditions

• Kidney Diseases

Interventions

Type	Name	Description
DRUG	methylprednisolone	withdrawal of methylprednisolone in arm A and continuous Steroid Treatment in arm B

Timeline

• Start date: 1999-03-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2006-03-31
• Last updated: 2015-04-23

Locations

1 site across 1 country: Germany