Understanding antibody-mediated rejection in kidney transplantation
Incidence, Course and Outcome of Cellular and Antibody-mediated Rejection in Immunological High-risk Kidney Transplantation, a Prospective Cohort PROCARE2 Study
This study is trying to see how well kidney transplants work and what happens to patients at high risk of rejection over a year after their surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 225 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 6 sites (Amsterdam and 5 other locations) |
| Trial ID | NCT05140018 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the incidence and outcomes of antibody-mediated rejection (ABMR) and mixed ABMR in patients receiving kidney transplants. It focuses on individuals who are at high immunological risk for rejection and will assess their graft survival, renal function, and other related parameters over a one-year follow-up period. The study will involve patients aged 18 and older who are about to undergo either post-mortal or living donor kidney transplantation. By analyzing the effects of current immunosuppressive regimens, the study seeks to provide insights into improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are kidney transplant recipients aged 18 and older who are at high immunological risk for antibody-mediated rejection.
Not a fit: Patients who do not have an immunological high risk for rejection will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for kidney transplant recipients, potentially reducing the incidence of graft loss due to rejection.
How similar studies have performed: Other studies have shown success in understanding rejection mechanisms in kidney transplantation, making this approach relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 Exclusion Criteria: * No immunological high risk
Where this trial is running
Amsterdam and 5 other locations
- Academisch Medisch Centrum — Amsterdam, Netherlands (Recruiting)
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
- Leiden University Medical Center — Leiden, Netherlands (Recruiting)
- Radboud University Hospital — Nijmegen, Netherlands (Recruiting)
- Erasmus MC — Rotterdam, Netherlands (Recruiting)
- Umcu — Utrecht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Jan-Stephan Sanders, MD PhD
- Email: j.sanders@umcg.nl
- Phone: +31503612955
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.