NL-OMON41595
Completed
Phase 4
Immune monitoring to characterize T-cell responses of kidney transplant patients during co-stimulation blockade by belatacept - Characterizing T-cell responses during belatacept treatment
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- acute rejection
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 41
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a) Male or female kidney transplant recipients.
- •b) Age \>\= 18 years.
- •c) Patients to be transplanted with a first or second kidney allograft.
- •d) Patients receiving a kidney allograft from a living donor.
- •e) Patients receiving a bloodgroup AB0\-compatible kidney transplant.
- •f) Patients receiving a non\-HLA identical kidney transplant.
- •g) Panel reactive antibodies (PRA) \<30%.
- •h) Patients must have known EBV serostatus, and that status must be positive.
- •i) Patients receiving a non\-HLA\-DR mismatched kidney transplant.
Exclusion Criteria
- •a) Recipients of a third (or higher) allograft.
- •b) Recipients of a non\-renal organ transplant.
- •c) Recipients of a kidney transplant from a deceased donor.
- •d) Recipients under the age of 18 years.
- •e) Sensitized transplant recipients (defined as a PRA of \>\=30%).
- •f) Recipients of a HLA\-identical kidney allograft.
- •g) Recipients of a bloodgroup AB0\-incompatible kidney allograft.
- •h) Recipients with a historically positive cross\-match.
- •i) Patients with a history of lymphoma.
- •j) Seronegative or unknown EBV serostatus.
Outcomes
Primary Outcomes
Not specified
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