ADOLESCE-NT: More rapid deterioration of renal function after renal transplantation in adolescence: effect of the endocrine system on immunological and pharmacokinetic factors
Recruiting
- Conditions
- kidney diseasenephropathy10029149
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 190
Inclusion Criteria
planned renal transplantation, or status after renal transplantation
age 8 - 30 years
Exclusion Criteria
No informed consent
treatment with rituximab or chemotherapy
pubertas precox
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary objective: the relationship of the endocrine and immunological status,<br /><br>measured as:<br /><br>1 T-cell flow cytometry<br /><br>2 Cytokine production capacity in Tnaive, Tmem and Treg subsets<br /><br>a Analysis of the cytokine production capacity of CD4 and CD8 naïve,<br /><br>and memory T cell subsets<br /><br>b Establishing the number and the origin of the CD4+CD25+CD127-FoxP3+<br /><br>T cells<br /><br>c STAT5 activation by GH and IL-2<br /><br>3 TREC levels, including normalization for DNA input </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objectives are the relationship of the endocrine status and<br /><br>pharmacokinetic parameters:<br /><br>1. Trough levels of CNI and MMF at every outdepartment consultation, and<br /><br>calculation of variability<br /><br>2. Ratio trough level / relative daily dose of CNI and MMF<br /><br>both in relation to polymorphisms of Cyp3a4 and 5, and ABCB1</p><br>