Kidney-transplant patients (Niertransplantatiepatiënten) Immunosuppression (Immunosuppressie) Co-stimulatory blockade (co-stimulatoire blockade) Immunology (Immunologie) Belatacept (Nulojix)
Conditions
Interventions
Belatacept treatment intravenously in stead of standard immunosuppressive therapy with tacrolimus orally.
Sponsors
Erasmus Medical Center/Erasmus University
Eligibility
Inclusion criteria
Inclusion criteria: 1) Signed Written Informed Consent Before any study procedures are performed, subjects will have the details of the study described to them, and they will be given a written informed consent document to read. Then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel. 2) Target Population: a) Male or female kidney transplant recipients. b) Age ¡Ý 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) Patients receiving an HLA-DR mismatched kidney transplant. h) Current PRA <30% i) Patients must have known EBV serostatus, and that status must be positive.
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 current PRA of ¡Ý30%) f) Recipients of a HLA-identical kidney allograft g) Recipients of an HLA-DR-identical kidney allograft h) Recipients of a bloodgroup AB0-incompatible kidney allograft i) Recipients with a historically positive cross-match j) Patients with a history of lymphoma k) Seronegative or unknown EBV serostatus l) Patients with tuberculosis who have not been treated for latent infection. m) Patients at high risk for polyoma virus-associated nephropathy, which is mostly due to BK virus infection. n) Pregnancy o) HIV, hepatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objectives: Lab endpoints 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 3. To assess Belatacept concentrations and neutralizing anti-Belatacept antibodies (PK study), saturation and functional consequences of CD80/CD86 receptor blockade by peripheral blood cells (PD study) | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of acute rejection (biopsy-confirmed or suspected clinically), and measurements of renal function (e.g. eGFR by the MDRD equation and urinary protein excretion) will documented and assessed in relation to the immunological and PD/PK measurements. The incidence of severe infections (necessitating hospital admission) and the incidence of malignancy (including PTLD) will be documented.However, formal comparisons between the experimental and control groups regarding clinical endpoints will only be performed as secondary analyses. | — |
Contacts
Public ContactD.A. Hesselink
Erasmus Medical Center 's-Gravendijkwal 230
Outcome results
None listed