Incidence and outcome of antibody-mediated rejection in immunological high-risk renal transplantation: An observational PROCARE 2.0 study
- Conditions
- humoral rejection10038430
- Registration Number
- NL-OMON52238
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 300
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- >=18 years old
- About to receive a deceased donor or living donor renal transplant
- Provide informed consent
- Immunological high risk for rejection
a. Luminex positive DSAs (Immucor background corrected MFI >500)8;
and/or
b. Re-transplantation with repeated mismatch; and/or
c. Husband to wife donation (after fathering children); and/or
d. Offspring to mother donation
The healthy subjects are the living donors of aforementioned patients, they
have to meet the following criteria,
- >=18 years old
- About to donate a kidney as a living donor
- Provide informed consent
A potential subject who meets the following criterium will be excluded from
participation in this study:
- Regular follow-up after transplantation is not feasible
- AB0-incompatible or HLA-incompatible kidney transplantation
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study endpoints are the incidence of ABMR, the incidence of mixed<br /><br>ABMR/TCMR, and kidney function after at least one year of follow-up. </p><br>
- Secondary Outcome Measures
Name Time Method <p>In addition, the immune system will be mapped with a focus on B cell function,<br /><br>the development of (non-)HLA antibodies, the interaction between B cells and T<br /><br>follicular helper cells, and complete immune phenotypic profiling. </p><br>