E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Kidney transplant cytomegalovirus-seropositive |
Trasplante renal citomegalovirus seropositivo |
|
E.1.1.1 | Medical condition in easily understood language |
Kidney transplant cytomegalovirus-seropositive |
Trasplante renal citomegalovirus seropositivo |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Meet the efficacy and safety of valganciclovir prophylaxis suspend in CMV-seropositive kidney transplant recipients with CD8 + cellular immunity CMV-specific transplant, receiving Thymoglobulin induction and maintaining cellular immunity CMV-specific CD8 + after transplantation. |
Conocer la eficacia y seguridad de suspender la profilaxis con valganciclovir en los trasplantados renales CMV-seropositivos, con inmunidad celular CD8+ CMV-especifica pretrasplante, que reciben inducción con timoglobulina y que mantienen la inmunidad celular CD8+ CMV-específica tras el trasplante. |
|
E.2.2 | Secondary objectives of the trial |
Percentage of patients developing T cell immunity in CMV-specific transplantation after receiving timoglubulina induction and valganciclovir prophylaxis. T cell development inmnunidad CD8 + CMVspecific is defined as production of ?> 0.2 interferon by CD8 + T cells stimulated by CMV-specific CMV antigens (QF reagent). |
Porcentaje de pacientes que desarrollan inmunidad celular T CMVespecífica en el postrasplante después de haber recibido inducción con timoglubulina y profilaxis con valganciclovir. Se definirá desarrollo de inmnunidad celular T CD8+ CMV-especifica como la producción de interferon ? > 0.2 por linfocitos T CD8+ CMV-específicos estimulados por antígenos de CMV (QF reactivo). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
CMV-seropositive kidney transplant, CD8 + T cell immunity specific pretransplant CMV (CMV-reactive Quantiferon pretraspante) > 18 years (adult) Receiving induction therapy with Thymoglobulin Receiving prophylaxis with valganciclovir. |
Trasplantados renales CMV-seropositivos, Inmunidad celular T CD8+ CMV especifica pretrasplante (Quantiferon- CMV pretraspante reactivo) > 18 años (adultos) Que reciban tratamiento de inducción con timoglobulina Que reciban profilaxis con valganciclovir. |
|
E.4 | Principal exclusion criteria |
Multivisceral transplants including kidney-pancreas HIV-infected patients Patients who can not comply with the monitoring protocol |
Trasplantes multiviscerales incluyendo páncreas-riñón Pacientes infectados por VIH Pacientes que no puedan cumplir con el protocolo de seguimiento |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of CMV disease at 12 months after transplantation. Study the predictive value of the assay of CD8 + T cell immunity specific for defined CMV-patients in which they can stop prophylaxis. The definition of CMV disease was based on those recommended by the American Society of Trasnplantation for use in clinical trials (Humar A. Am J Transplant 2006; 6:262-74) criteria. |
Incidencia de enfermedad por CMV a los 12 meses del trasplante. Estudiaremos el valor predictivo del ensayo de inmunidad celular T CD8+ CMV-especifica para definir los pacientes en los que se puede suspender la profilaxis. La definición de la enfermedad por CMV se basará en los criterios recomendados por la American Society of Trasnplantation para uso en ensayos clínicos (Humar A. Am J Transplant 2006;6:262-74). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Percentage of patients developing T cell immunity in CMV-specific transplantation after receiving timoglubulina induction and valganciclovir prophylaxis. T cell development inmnunidad CD8 + CMVspecific defined as production of ?> 0.2 interferon by CD8 + T cells stimulated by CMV-specific CMV antigens |
Porcentaje de pacientes que desarrollan inmunidad celular T CMVespecífica en el postrasplante después de haber recibido inducción con timoglubulina y profilaxis con valganciclovir. Se definirá desarrollo de inmnunidad celular T CD8+ CMV-especifica como la producción de interferon ? > 0.2 por linfocitos T CD8+ CMV-específicos estimulados por antígenos de CMV |
|
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) | 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 | No |
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 | Information not present in EudraCT |
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 | 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 | 9 |
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
|
LVLS |
Ultima visita del ultimo sujeto |
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |