E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Antiobdy mediated rejection after kidney transplant |
RECHAZO MEDIADO POR ANTICUERPOS EN RECEPTORES DE TRASPLANTE DE RIÑON |
|
E.1.1.1 | Medical condition in easily understood language |
Kidney transplant rejection |
RECHAZO TRASPLANTE DE RIÑON |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064683 |
E.1.2 | Term | Antibody-mediated rejection |
E.1.2 | System Organ Class | 10021428 - Immune system disorders |
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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 evaluate the safety and efficacy of eculizumab in the prevention of antibody mediated rejection (AMR) in living donor kidney recipients requiring desensitization therapy |
Evaluar la seguridad y la eficacia de eculizumab en la prevención del Rechazo Mediado Por Anticuerpos (RMA) en receptores de trasplantes renales de donantes vivos que requieren terapia de desensibilización |
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E.2.2 | Secondary objectives of the trial |
Safety and Efficacy |
La seguridad y la eficacia |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female patients ≥ 18 years old
- Patients with Stage IV or Stage V chronic kidney disease who will receive a kidney transplant from a living donor to whom they are sensitized and require desensitization prior to transplantation
- Patients must be willing and able to give written informed consent |
-Pacientes, hombres o mujeres, ≥ 18 años
-Pacientes con enfermedad renal crónica en estadio IV o V que recibirán un trasplante de riñón de un donante vivo para el que son sensibles y requieren una terapia de desensibilización antes del trasplante
- Los pacientes deben estar dispuestos y ser capaces de dar su consentimiento informado por escrito
|
|
E.4 | Principal exclusion criteria |
- Has received treatment with eculizumab at any time prior to enrolling in this study
- ABO incompatible with living donor |
- Haber recibido tratamiento con eculizumab en cualquier momento antes de su inclusion en este estudio
- ABO incompatible con el donante vivo |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the safety and efficacy of eculizumab to prevent AMR in sensitized recipients of living donor kidney transplants requiring desensitization therapy. |
Evaluar la seguridad y la eficacia de eculizumab en la prevención del Rechazo Mediado Por Anticuerpos (RMA) en receptores de trasplantes renales de donantes vivos que requieren terapia de desensibilización. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Cumulative incidence of AMR that occur between week 9 and month 12 post-transplantation. |
Incidencia acumulada del Rechazo Mediado Por Anticuerpos (RMA) que se produce entre la semana 9 y el mes 12 tras el trasplante |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Canada |
United States |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
last visit of the last patient |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |