The immune response during treatment with belatacept after kidney transplantation.

• Conditions: Kidney transplantation; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2012-003169-16-NL
• Lead Sponsor: Erasmus MC, University Medical Center Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-23
• Last Update Posted: 13 May 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

a) Male or female kidney transplant recipients.
b) Age = 18 years.
c) Patients receiving a first or second kidney allograft.
d) Patients receiving a kidney allograft from a living donor.
e) Patients receiving a bloodgroup AB0-compatible kidney allograft.
f) Patients receiving a non-HLA identical kidney transplant.
g) PRA <30%
h) Patients must have known EBV serostatus, and that status must be positive.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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, which is mostly due to BK virus infection.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To characterize the function and phenotype of peripheral T-cells that determine rejection and graft acceptance during belatacept therapy after kidney transplantation.;Secondary Objective: Not applicable.;Primary end point(s): 1) To determine the presence, frequency, characteristics of effector CD4+ and CD8+ T cells<br>2) To analyze T-B cell interaction during co-stimulation blockade<br>;Timepoint(s) of evaluation of this end point: Pre-transplantation and months 3, 6 and 12 after transplantation.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.