Kidney transplantation
Conditions
Interventions
Trade Name: Belatacept (Nulojix)
Product Name: Belatacept (Nulojix)
Pharmaceutical Form: Concentrate and solvent for solution for infusion
Sponsors
Erasmus MC, University Medical Center Rotterdam
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 2) To analyze T-B cell interaction during co-stimulation blockade ;Timepoint(s) of evaluation of this end point: Pre-transplantation and months 3, 6 and 12 after transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Countries
Netherlands
Contacts
Public ContactDepartment of Internal Medicine
Erasmus MC, University Medical Center Rotterdam
Outcome results
None listed