Randomized Study to Reduce Calcineurininhibitor Toxicity in Pediatric and Adolescent Kidney Transplant Recipients

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if a safe reduction of cyclosporine A in pediatric and adolescent patients with stable renal graft function, reduces signs of calcineurin-inhibitor toxicity.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Erlangen-Nürnberg Medical School
• Treatments: Calcineurin Inhibitors; Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

• age at inclusion 3-16 years

• male or female patients

• recipient of first or second renal transplant

• graft age > 24 months

• last acute rejection episode > 6 months ago

• Immune suppression comedication Mycophenolatmofetil (MMF) in a dose range of 1200 +/- 200 mg/m² BSA/d within at least 6 months or minimal MPA-AUC ≥ 45 mg x h/l. If MPA-AUC < 45 mg x h/l adjustment of dosage with re-screening in ≥ 4 weeks is possible.

• Application of CSA in stable dosing within the last 3 months before study inclusion and CSA-C2-level > 500 ng/ml. If CSA-C2-level < 500 ng/ml adjustment of dosage with re-screening in ≥ 4 weeks is possible.

• steroid-free immunosuppression for at least 6 months before enrollment

• biopsy of the renal graft without any signs of acute rejection (def. according to BANFF classification), within 3 months before enrollment

• written informed consent of parents/legal guardians and, if applicable, patient's consent

Exclusion Criteria:

• glomerular filtration rate < 40 ml/min/1.73 m2 BSA (acc. to Schwartz' formula) at time of enrollment

• > 2 episodes of acute graft rejection within 12 months prior to enrollment

• condition after steroid-resistant graft rejection

• actual participation in another clinical trial

• Recurrence of primary renal disease in the graft

• proven infection with EBV and/ or CMV and antiviral therapy within 3 months prior to enrollment

• proven infection with polyoma virus within 3 months prior to enrolment

• pregnant or nursing women

• hemoglobin < 8 g/dl at screening visit

• non-treated arterial hypertension

• uncontrolled infectious disease

• history of malignancy of any organ system, treated or non-treated