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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42749

Enrollment

100

Registered

2015-07-23

Start date

2015-08-21

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

niertransplantatie rejection of kidney allograft

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time 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

Measure	Time frame
Secondary objectives of the study are: - to capture global composition of lymph node and blood leukocyte subsets [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. (ABO-incompatible kidney transplant recipients receive alemtuzumab induction therapy three weeks before transplantation).	—

Measure

Time frame

Secondary objectives of the study are: - to capture global composition of lymph node and blood leukocyte subsets [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. (ABO-incompatible kidney transplant recipients receive alemtuzumab induction therapy three weeks before transplantation).

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Countries

Netherlands

Outcome results