Immune monitoring to characterize T-cell responses of kidney transplant patients during co-stimulation blockade by belatacept

Phase 4

Completed

• Conditions: acute rejection; Kidney transplantation; 10027665; 10029149; 10038365

• Registration Number: NL-OMON41595
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-02-21
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 41

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.
k) Patients with tuberculosis who have not been treated for (latent) infection.
l) Patients at high risk for polyoma virus-associated nephropathy.
m) Patients receiving an HLA-DR mismatched kidney transplant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified