E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Kidney transplantation |
Niertransplantatie |
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E.1.1.1 | Medical condition in easily understood language |
Kidney transplantation |
Niertransplantatie |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To characterize the function and phenotype of peripheral T-cells that determine rejection and graft acceptance during belatacept therapy after kidney transplantation. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Pre-transplantation and months 3, 6 and 12 after transplantation. |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Historical control group receiving standard immunosuppressive therapy |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Month 12 after kidney transplantation. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |