children with kidney graft MedDRA version: 9.1 Level: LLT Classification code 10023438 Term: Kidney transplant
Conditions
Interventions
Trade Name: Sandimmun optoral 10 mg capsules
Pharmaceutical Form: Capsule*
INN or Proposed INN: Ciclosporin A
CAS Number: 59865-13-3
Concentration unit: mg milligram(s)
Concentration type: equal
Conce
Sponsors
Universitaetsklinikum Erlangen-Nuernberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age at inclusion 3 – 16 years 2. Male or female patients 3. Condition after first or second isolated renal transplantation 4. Graft age > 24 months 5. Last acute rejection > 6 months ago 6. 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 500 ng/ml. If CSA-C2-level =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. GFR < 40 ml/min/1,73 m² body surface area acc. to Schwartz' formula at study start 2. More than 2 acute graft rejections within the last 12 months before start of the clinical trial 3. Condition after steroid resistant rejection in the past 4. Actual participation in another clinical therapy trial 5. Proof of a recidive of the basic disease in the renal graft 6. Patients with proof of EBV- or CMV- infection and indication of antiviral therapy within the last 3 months before study inclusion 7. Patients with proof of manifest Poliomavirus infection within the last 3 months before study inclusion 8. Pregnancy and lactation 9. Hemoglobin < 8 g/dl at screening visit 10. Untreated arterial hypertonia 11. Uncontrolled infectious disease 12. Any malign tumours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of efficacy and safety of Ciclosporine-A (CSA) dose reduction by 20 % and corresponding CSA serum level reduction in pediatric renal graft patients in comparison to a control group on constant, standard dose CSA treatment in steroid-free long-term immune suppression with Mycophenolat mofetil (MMF) comedication and the effect of CSA-dose reduction on the decrease of CSA-toxicity and therefore stabilisation of kidney graft function in the long run. ;Secondary Objective: 1. Analysis of safety parameters (biopsy of kidney graft after 12 months; blood pressure; safety laboratory parameters; incidence/seriousness of infections and serious adverse events). 2. To proof the superiority of the "NFAT" laboratory method, the inhibiton of transcription of „nuclear factor of activated T cells“ (NFAT) – regulated intracellular cytokines quant. PCR analysis as measurement of biological action of CSA-activity in blood vs. conventional determination of CSA serum levels. 3. Determination of psychosocial burden under reduced and standard CSA-treatment by test versions TNO-AZL Child quality of life, Child behavior checklist, Teacher report form, Youth self report, Family relationship index and Life events form. 4. To obtain new insights by screening for metabolites conjunct with clinic features of nephrotoxicity or graft rejections a metabolomic screening and a targeted analysis (Trimethylamin-N-oxide, Neopterin and Kynurenin/Tryptophan ratio) will be performed.;Primary end point(s): Mean decline per month in glomerular filtration rate (calculated acc. to Schwartz) during the study from 0 to 24 months compared between the CSA-dose-reduction and the constant-CSA dosage arm. | — |
Countries
Germany
Outcome results
None listed