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The relevance of donorspecific memory B cells in immunised kidney transplant recipients


- candidate number18406
- NTR NumberNTR4695
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-jul-2014
- Secondary IDsP13.025 NL42616.058.12
- Public TitleThe relevance of donorspecific memory B cells in immunised kidney transplant recipients
- Scientific TitleThe relevance of donorspecific memory B cells in immunised kidney transplant recipients
- ACRONYMDonorspecific memory B cells in kidney transplantation
- hypothesisThe presence of a broadly reactive anti-donor specific memory B cell compartment is a risk factor for an accelerated memory response after transplantation.
- Healt Condition(s) or Problem(s) studiedRenal transplant , Renal transplant recipients, B cells
- Inclusion criteriaPatients who will undergo a kidney retransplant and, if applicable, their living kidney donor
- Exclusion criteriaHepatitis C or HIV seropositive individuals
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-aug-2013
- planned closingdate31-jul-2015
- Target number of participants100
- InterventionsN/A
- Primary outcomeThe main parameter to be assessed in the current study is the frequency of donor-specific memory B cells as determined by a novel ELISPOT based technique. Furthermore, donor-specific antibody levels will be determined by CDC and Luminex techniques.
- Secondary outcomeThe secondary study parameters are clinical parameters. The transplant function at 6 and 12 months will be determined by the estimated Glomerular Filtration Rate (eGFR), calculated by the Modification of Diet in Renal Disease (MDRD) formula. Furthermore, the occurrence of cellular and antibody mediated rejection within the first year after transplantation will be recorded.
- TimepointsPeripheral blood (30 ml per time point) will be drawn by venapuncture at 3 time points (pre-transplant, at 3 and 6 months post-transplantation). Clinical follow-up will be performed up to 1 year after transplantation. In case of a living donor transplant, 30 ml of peripheral blood will be drawn from the kidney donor once before the explantation.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES S. Heidt
- CONTACT for SCIENTIFIC QUERIES S. Heidt
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Nierstichting
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD16-jul-2014 - 15-aug-2014


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