ADOLESCE-NT: More rapid deterioration of renal function after renal transplantation in adolescence: effect of the endocrine system on immunological and pharmacokinetic factors

ADOLESCE-NT: More rapid deterioration of renal function after renal transplantation in adolescence: effect of the endocrine system on immunological and pharmacokinetic factors - ADOLESCE-NT

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43848

Enrollment

190

Registered

2012-03-15

Start date

2012-04-12

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

kidney disease nephropathy

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: planned renal transplantation, or status after renal transplantation age 8 - 30 years

Exclusion criteria

Exclusion criteria: No informed consent treatment with rituximab or chemotherapy pubertas precox

Design outcomes

Primary

Measure	Time frame
Primary objective: the relationship of the endocrine and immunological status, measured as: 1 T-cell flow cytometry 2 Cytokine production capacity in Tnaive, Tmem and Treg subsets a Analysis of the cytokine production capacity of CD4 and CD8 naïve, and memory T cell subsets b Establishing the number and the origin of the CD4+CD25+CD127-FoxP3+ T cells c STAT5 activation by GH and IL-2 3 TREC levels, including normalization for DNA input	—

Measure

Time frame

Primary objective: the relationship of the endocrine and immunological status, measured as: 1 T-cell flow cytometry 2 Cytokine production capacity in Tnaive, Tmem and Treg subsets a Analysis of the cytokine production capacity of CD4 and CD8 naïve, and memory T cell subsets b Establishing the number and the origin of the CD4+CD25+CD127-FoxP3+ T cells c STAT5 activation by GH and IL-2 3 TREC levels, including normalization for DNA input

—

Secondary

Measure	Time frame
The secondary objectives are the relationship of the endocrine status and pharmacokinetic parameters: 1. Trough levels of CNI and MMF at every outdepartment consultation, and calculation of variability 2. Ratio trough level / relative daily dose of CNI and MMF both in relation to polymorphisms of Cyp3a4 and 5, and ABCB1	—

Countries

Netherlands

Outcome results