Status:
TERMINATED
Randomized Study to Reduce Calcineurininhibitor Toxicity in Pediatric and Adolescent Kidney Transplant Recipients
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Kidney Transplant
Eligibility:
All Genders
3-16 years
Phase:
PHASE4
Brief 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.
Detailed Description
Chronic transplant nephropathy is one of the major causes of graft loss after renal transplantation. Toxicity of calcineurin-inhibitors is suspected to be one cause for loss of graft function. Therefo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00663455
Start Date
December 1 2008
End Date
June 1 2013
Last Update
June 4 2015
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Dept. of Pediatric Nephrology, University Hospital Erlangen
Erlangen, Germany
2
Dept. of Pediatric Nephrology, University Hospital Freiburg
Freiburg im Breisgau, Germany
3
Dept. of Pediatric Nephrology, University Hospital Hamburg
Hamburg, Germany
4
Dept. of Pediatric Nephrology, University Hospital Hannover
Hanover, Germany