Incidence, Course and Outcome of Cellular and Antibody-mediated Rejection in Immunological High-risk Kidney Transplantation, a Prospective Cohort PROCARE2 Study
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure, Combination product
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
‣ Luminex positive DSAs ; or
⁃ Retransplantation with repeated mismatch ; or
⁃ Husband to wife donation (after fathering children); or
⁃ Offspring to mother donation
Locations
Other Locations
Netherlands
Academisch Medisch Centrum
RECRUITING
Amsterdam
University Medical Center Groningen
RECRUITING
Groningen
Leiden University Medical Center
RECRUITING
Leiden
Radboud University Hospital
RECRUITING
Nijmegen
Erasmus MC
RECRUITING
Rotterdam
UMCU
RECRUITING
Utrecht
Contact Information
Primary
Jan-Stephan Sanders, MD PhD
j.sanders@umcg.nl
+31503612955
Backup
Joost van den Born, MD PhD
j.c.van.den.born@umcg.nl
+31503612955
Time Frame
Start Date:2022-01-01
Estimated Completion Date:2026-03-01
Participants
Target number of participants:225
Treatments
Kidney Transplant Recipients with an immunological high risk for ABMR
* Kidney transplant recipients ≥18 years old~* About to receive a post mortal or living donor renal transplant~* Immunological high risk for rejection~ 1. Luminex positive DSAs ; or~ 2. Retransplantation with repeated mismatch ; or~ 3. Husband to wife donation (after fathering children); or~ 4. Offspring to mother donation
Living Kidney Donors
Participants who are about to donate their kidney to a Recipient with a high immunological risk (as described above)
Collaborators: UMC Utrecht, Dutch Kidney Foundation, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Radboud University Medical Center, Maastricht University Medical Center, Erasmus Medical Center, Leiden University Medical Center