|- candidate number||12882|
|- NTR Number||NTR3470|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-jun-2012|
|- Secondary IDs||38406 ABR|
|- Public Title||ADOLESCE-NT Studie.|
|- Scientific Title||More rapid deterioration of renal function after renal transplantation in adolescence: effect of the endocrine system on immunological and pharmacokinetic factors.|
|- hypothesis||1. The in vitro immunological reactivity is higher in adolescence compared to adjacent age categories which leads to a higher risk of rejection of the transplanted kidney;|
2. More naïve T-cells are present in the circulation in adolescence compared to adjacent age categories, measured as CD31+ T-cells and TREC levels;
3. Hormonal status does not influence metabolism of immunosuppressive drugs.
|- Healt Condition(s) or Problem(s) studied||Renal transplant , Children, Adolescents, Rejection, Transplant survival|
|- Inclusion criteria||1. Patients planned for renal transplantation, or after renal transplantation;|
2. Age 10 – 25 years.
|- Exclusion criteria||1. No informed consent given;|
2. Treatment with rituximab or chemotherapy;
3. Pubertas precox (puberty before the 8th year of life).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-apr-2012|
|- planned closingdate||1-apr-2015|
|- Target number of participants||125|
|- Interventions||1. Blood drawn by venous puncture;|
2. X-ray of the hand;
3. Determining puberty stage;
|- Primary outcome||The relationship of the endocrine status (serum hormonal levels and skeletal age) and immunological status.|
|- Secondary outcome||The relationship of the endocrine status and pharmacokinetic parameters.|
|- Timepoints||0, 3 months, 1 year.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. K.M.E. Meys|
|- CONTACT for SCIENTIFIC QUERIES||Drs. K.M.E. Meys|
|- Sponsor/Initiator ||Erasmus Medical Center|
(Source(s) of Monetary or Material Support)
|Stichting Sporten voor Sophia|
|- Brief summary||Rationale: |
Regarding renal transplantations at childhood age, transplant survival for transplantation at ages 14-18 years is inferior to that at other ages. Possible reasons are poor therapy compliance but also age-related differences in immunological processes or pharmacokinetics. Growth hormone seems to be important in the control of thymus activity.
We hypothesize that there is a stronger immunological reactivity in adolescence which leads to a higher risk of rejection of the transplanted kidney, TREC levels will be higher in adolescence than in other age categories and are associated with the hormonal status, there is a relation between levels of IGF-1 and the activity of T-cells, and hormonal status influences metabolism of immunosuppressives.
The main objective of this study is to analyse the relation between the hormonal status and phenotyping and stimulability of immunological parameters.
The secondary objective is to analyse the relation between the hormonal status and pharmacokinetic parameters.
Prospective cross-sectional (single centre) study and longitudinal observational (multicentre) study.
Study population: the study population consists of 25 patients awaiting renal transplant, 50 patients at least one year after kidney transplantation and 50 healthy human volunteers, all between the age of 10 and 25 years old.
Main study parameters/endpoints:
Primary objective: The relationship of the endocrine (serum hormonal levels and skeletal age) and immunological status.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Burden: blood sample of maximally 20 ml (once for the control group, twice for the cross-sectional group with interval of 1 year, 3 times for the prospective group taken over a 1 year period) and X-ray of the hand is required, physical examination will take place. For the patients no additional visits are necessary since the investigations will take place on regular visit days. Since the control group will be composed of pupils of the nearby Secondary School and students of the University, the burden of transport is minimal.
The risks of an X-ray of the hand and a venipuncture are negligible. There is no investigational product involved associated with risks.
Minors are included because the study specifically analyses the changes that occur in adolescence and the effect on immunological and pharmacokinetic factors.
|- Main changes (audit trail)|
|- RECORD||11-jun-2012 - 20-jun-2012|