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| Name | Class |
|---|---|
| Dutch Kidney Foundation | OTHER |
| UMC Utrecht | OTHER |
| Leiden University Medical Center | OTHER |
| Maastricht University Medical Center |
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Rationale: Despite improved patient and graft survival in renal transplant recipients, still 20% of the patients reaches end-stage renal disease within 5 years after transplantation. Antibody-mediated rejection (ABMR) is one of the major causes of early graft loss and perhaps even more important of late deterioration of graft function
Objective: Evaluate the occurrence of antibody mediated rejection (ABMR) and mixed ABMR and cellular/ T-cell mediated rejection (TCMR), in patients treated with the currently prevailing immunosuppressive regimens, and relate them to outcome (graft survival, function, proteinuria, histology)
Study design: Clinical cohort study.
Study population: patients of >18 years old, about to receive a post mortal of living donor renal transplant with an immunological high risk for ABMR.
Main study parameters/endpoints: main study endpoints are the occurrence of ABMR, mixed ABMR/TCMR and renal function after 1 year of follow-up.
The main study parameter will be mapping the immune system, including B-cells, (non-)HLA antibodies, interaction between B-cells and T follicular helper cells, and complete immune profiling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kidney Transplant Recipients with an immunological high risk for ABMR |
|
| |
| Living Kidney Donors | Participants who are about to donate their kidney to a Recipient with a high immunological risk (as described above) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kidney Transplantation | Procedure | All participants will receive a kidney transplantation from a living donor or deceased donor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Antibody-Mediated Rejection (ABMR) | Incidence of Antibody-Mediated Rejection (ABMR) as histopathological diagnosis | within 12 months after transplantation |
| Incidence of mixed Antibody-Mediated Rejection / T-Cell Mediated Rejection (ABMR/TCMR) | Incidence of mixed Antibody-Mediated Rejection / T-Cell Mediated Rejection as histopathological diagnosis(ABMR/TCMR) as histopathological diagnosis | within 12 months after transplantation |
| Kidney transplant function | as measured by eGFR and proteinuria | at 12 months after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Development of Human-Leukocyte Antigen (HLA) antibodies | As measured by Luminex assay at 3 and 12 months | At 3 and 12 months after transplantation |
| Development of non-HLA antibodies | Development of non-HLA antibodies as measured by a cell-based endothelial assay |
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Inclusion Criteria:
Kidney transplant recipients ≥18 years old
About to receive a post mortal or living donor renal transplant
written informed consent (is able to read of understand in Dutch)
Immunological high risk for rejection
Exclusion Criteria:
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Patients with eind-stage renale disease (ESRD) who are about to receive a kidney transplant from a living or deceased donor, with an elevated immunological risk (higher risk for (antibody-mediated) rejection).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan-Stephan Sanders, MD PhD | Contact | +31503612955 | j.sanders@umcg.nl | |
| Joost van den Born, MD PhD | Contact | +31503612955 | j.c.van.den.born@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| Hendrikus Otten, PhD | UMC Utrecht | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academisch Medisch Centrum | Recruiting | Amsterdam | Netherlands |
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| OTHER |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
| Erasmus Medical Center | OTHER |
| Radboud University Medical Center | OTHER |
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Peripheral Blood Mononuclear Cells (PBMCs) Kidney biopsy material (in case when kidney biopsy is performed in the follow-up) Iliac lymph nodes from 15 selected kidney transplant recipients
| Immunosuppression | Combination Product | All participants will receive immunosuppresive drugs to prevent rejection of de kidney transplant graft. |
|
| Nephrectomy (kidney donation) | Procedure | All kidney donors will receive a nephrectomy for kidney donation |
|
| At 3 and 12 months after transplantation |
| Kidney transplant survival | Kidney transplant survival in patients experiencing ABMR versus those not experiencing ABMR | At 12 months after transplantation |
| University Medical Center Groningen | Recruiting | Groningen | Netherlands |
|
| Leiden University Medical Center | Recruiting | Leiden | Netherlands |
|
| Radboud University Hospital | Recruiting | Nijmegen | Netherlands |
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| Erasmus MC | Recruiting | Rotterdam | Netherlands |
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| UMCU | Recruiting | Utrecht | Netherlands |
|
| ID | Term |
|---|---|
| D016030 | Kidney Transplantation |
| D007165 | Immunosuppression Therapy |
| D009392 | Nephrectomy |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
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