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Lymfklier alloreactiviteit in niertransplantatie.

Lymphnodes with and without Alemtuzumab to Measure Broad Alloreactivity against Donor Antigens

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26812
Enrollment
Unknown
Registered
2015-10-12
Start date
2015-09-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

kidney transplantation/ niertransplantatie rejection/ rejectie alloreactivity/ alloreactiviteit lymph nodes/ lymfklieren

Interventions

80 patients in group 1 (ABO-compatible) 20 patients in group 2 (ABO-incompatible)

Sponsors

Erasmus Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet the following criteria: - Adult patients receiving a deceased or living kidney transplant in the Erasmus Medical Center Rotterdam, The Netherlands and: - Group 1: o Historical PRA > 6% and/ or: o HLA MM ¡Ý4 on A, B and DR loci - Group 2: o Recipients of an ABO-incompatible kidney graft. Patients have to give written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - ABO-compatible HLA identical living-related transplant recipients. - Patients unable to give written informed consent.

Design outcomes

Primary

MeasureTime frame
-The primary objective for this study is to determine the prognostic characteristics for BPAR in the first 3 months after transplantation, as assessed in the lymphocyte composition of the lymph node in immunologically high-risk kidney transplantation.

Secondary

MeasureTime frame
Secondary objectives of the study: - to capture global composition of lymph node versus blood leukocyte subsets in renal insufficiency[20]. - to compare the immunological ageing profile of T cells in the peripheral blood to the T cells derived from the lymph node. - to assess whether pre-transplant frequencies of lymph node derived TFH, T and B cells predict BPAR. - to assess differences in lymphocyte composition of lymph nodes in alemtuzumab treated versus untreated patients both in single cell suspension and within the tissue [21, 22]. (ABO-incompatible kidney transplant recipients receive alemtuzumab induction therapy three weeks before transplantation). This study will result in a set of defined markers that will identify patients at risk to develop rejection.

Contacts

Public ContactA.E. Weerd, de

Internist-nephrologist Erasmus Medical Center Room D-411 Postbus 2040

a.deweerd@erasmusmc.nl0031-10-7034607

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)