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Incidence and outcome of antibody-mediated rejection in immunological high-risk renal transplantation: An observational PROCARE 2.0 study

Incidence and outcome of antibody-mediated rejection in immunological high-risk renal transplantation: An observational PROCARE 2.0 study - PROCARE 2.0

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52238
Enrollment
300
Registered
2021-09-01
Start date
2021-04-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

humoral rejection

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
The main study endpoints are the incidence of ABMR, the incidence of mixed ABMR/TCMR, and kidney function after at least one year of follow-up.

Secondary

MeasureTime frame
In addition, the immune system will be mapped with a focus on B cell function, the development of (non-)HLA antibodies, the interaction between B cells and T follicular helper cells, and complete immune phenotypic profiling.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)