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

Completed

Conditions: niertransplantatie
rejection of kidney allograft
10038430

Registration Number: NL-OMON42749

Lead Sponsor: Interne Geneeskunde, sector Nefrologie en Niertransplantatie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Adult patients receiving a deceased or living kidney transplant in the Erasmus Medical Center Rotterdam, The Netherlands and:
- Group 1:
o Historical PRA (panel reactive antibodies) > 6% and/ or:
o HLA MM (human leucocyte antigen mismatches) >=4 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

- ABO-compatible HLA identical living-related transplant recipients.
- Patients unable to give written informed consent.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective for this study is to determine the prognostic<br /><br>characteristics for BPAR in the first 3 months after transplantation, as<br /><br>assessed in the lymphocyte composition of the lymph node in immunologically<br /><br>high-risk kidney transplantation. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives of the study are:<br /><br>- to capture global composition of lymph node and blood leukocyte subsets [20].<br /><br>- to compare the immunological ageing profile of T cells in the peripheral<br /><br>blood to the T cells derived from the lymph node.<br /><br>- to assess whether pre-transplant frequencies of lymph node derived TFH, T and<br /><br>B cells predict BPAR.<br /><br>- to assess differences in lymphocyte composition of lymph nodes in alemtuzumab<br /><br>treated versus untreated patients both in single cell suspension and within the<br /><br>tissue. (ABO-incompatible kidney transplant recipients receive alemtuzumab<br /><br>induction therapy three weeks before transplantation).</p><br>