|- candidate number||15565|
|- NTR Number||NTR4242|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-okt-2013|
|- Secondary IDs||BMS no. 55230 |
|- Public Title||Belatacept study|
|- Scientific Title||BELATACEPT; NULOJIX|
|- hypothesis||IMMUNE MONITORING TO CHARACTERIZE T-CELL
RESPONSES OF KIDNEY TRANSPLANT PATIENTS DURING COSTIMULATION BLOCKADE BY BELATACEPT|
|- Healt Condition(s) or Problem(s) studied||Renal transplant , Immunosuppression, Immunoglobulin|
|- 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||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.
o) HIV, hepatitis
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2013|
|- planned closingdate||1-mei-2015|
|- Target number of participants||40|
|- Interventions||Belatacept treatment intravenously in stead of standard immunosuppressive therapy with tacrolimus orally.|
|- Primary outcome||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 outcome||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.|
|- Timepoints||Belatacept treatment will be given intravenously on the following time points:
- day 0 (during transplantation), day 4, day 15, day 30 (¡À5), day 60 (¡À5), day 90 (¡À5), and every month from month 4 till month 12 (¡À 7 days)
- Starting dose is 10 mg/kg. From month 4 till month 12 this dose will be reduced to 5 mg/kg
Tacrolimus will be given daily. Doses are based on trough-concentrations.
Blood withdrawals for laboratory tests will take place on the following time points in all patients:
day 0, 4, 30 (¡À5), 90 (¡À5), 180 (¡À7) and 365 (¡À7), and when clinical suspicion for rejection exists. All blood withdrawals are before administration of belatacept or tacrolimus, or anti-rejection treatment.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| D.A. Hesselink|
|- CONTACT for SCIENTIFIC QUERIES|| D.A. Hesselink|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Bristol-Myers Squibb B.V.|
|- Brief summary||Randomized controlled trial with kidney-transplant patients. Treatment arms are belatacept or tacrolimus (standard), both N=20. Primary outcomes are immunological parameters. Secondary outcomes are clinical end points.|
|- Main changes (audit trail)|
|- RECORD||17-okt-2013 - 19-nov-2013|