E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Delayed Graft Function |
Funcion retardada del injerto |
|
E.1.1.1 | Medical condition in easily understood language |
Delayed Graft Function |
Funcion retardada del injerto |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048747 |
E.1.2 | Term | Renal graft function delayed |
E.1.2 | System Organ Class | 100000004863 |
|
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 |
Efficacy and safety of eculizumab to prevent DGF in adult diseased donor kidney transplants recipients at increased risk of DGF. |
Eficacia y seguridad de eculizumab para la prevención de la función retardada del injerto despues del trasplante renal en pacientes adultos con riesgo elevado de función retardada del injerto. |
|
E.2.2 | Secondary objectives of the trial |
- Safety and tolerability of eculizumab. - Efficacy (graft function, subject and graft survival, biopsy proven acute rejection). |
-Seguridad y tolerabilidad de eculizumab -Eficacia (función del injerto, supervivencia del paciente e injerto, biopsy que prueba rechazo agudo). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- male or female, 18 years or older - Subject with dialysis dependent renal failure (initiated more than 2 months prior to transplant). - Subject is to receive a first kidney transplant from a deceased donor at risk of DGF - Subject able to provide written informed consent - Female subjects of child-bearing potential must have a negative serum pregnancy test (serum beta-hCG) and an approved contraceptive regimen |
-Hombre o mujer de 18 años o más -Paciente con insuficiencia renal dependiente de diálisis (iniciada más de 2 meses antes del trasplante) -El paciente va a recibir un primer trasplante de riñón de un donante fallecido con riesgo de función retardad del injerto -Paciente capaz de dar su consentimiento informado por escrito -Mujeres con capacidad de concebir deben tener una prueba de embarazo sérica (beta-hCG sérica) negativa y deben practicar un método anticonceptivo eficaz. |
|
E.4 | Principal exclusion criteria |
- Subject to receive multi-organ transplant - Subject to receive kidney(s) from donors < 6 years of age - Subject to receive a dual kidney transplant (from same donor, including en bloc) - Subject to receive a living donor kidney - Subject is highly sensitized to the donor - Subject has received any previous transplant |
-Paciente que va a recibir un trasplante de múltiples órganos -Paciente que va a recibir riñones de donantes de < 6 años de edad -Paciente que va a recibir un trasplante renal dual (del mismo donante, incluyendo trasplante en bloque) -Paciente que va a recibir un riñón de donante vivo -Paciente está muy sensibilizado al donante -El paciente ha recibido un trasplante previo. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of DGF |
Incidencia de función retardad del injerto |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
First week post transplantation |
Primera semana después del trasplante |
|
E.5.2 | Secondary end point(s) |
- Graft function - need for dialysis - Estimated Glomerular Filtration Rate (eGFR) - Rejection-free graft survival |
-Función del injerto -Necesidad de dialisis -Tras aestimada de filtración glomerular (TFGe) -Supervivencia del injerto sin rechazo |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
-Graft function : first 7 days post transplantation -Need for dialysis : first 30 post transplantation -Estimated Glomerular Filtration Rate : days 7, 14, 28, 60, 90, weeks 26 and week 52 post transplantation -Rejection-free graft survival : week 26 and week 52 post transplantation |
-Función del injerto: primeros 7 días después del trasplante -Necesidad de dialisis: primeros 30 días después del trasplante -Tras aestimada de filtración glomerular (TFGe): dias 7, 14, 28, 60, 90, semana 26 y semana 52 después del trasplante -Supervivencia del injerto sin rechazo: semana 26 y semana 52 después del trasplante |
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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 | 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) | Yes |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 38 |
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 |
Czech Republic |
France |
Germany |
Italy |
Spain |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
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 | 2 |
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 |