Randomized Clinical Trial, Open, Multicenter Parallel, no Suspension Inferiority Prophylactic Treatment With Valganciclovir in Kidney Transplant CMV-seropositive Cellular Immunity to Develop CD8 + CMV-specific Treatment After Induction Thymoglobulin.
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|ClinicalTrials.gov Identifier: NCT03123627|
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : March 15, 2018
Hypothesis: Valganciclovir prophylaxis can be discontinued before 3 months in CMV-seropositive renal transplant recipients receiving induction thymoglobulin when developing CMV-specific cellular immunity after transplantation.
Objective 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 maintain cellular immunity-specific CD8 + CMV after transplantation.
Design: noninferiority clinical trial (study A) in CMV-seropositive kidney transplant recipients with CMV-specific cellular immunity pretransplant (Quantiferon reactive CMV) received induction with thymoglobulin
Patients meeting inclusion criteria will be randomized to:
- Control Arm: valganciclovir prophylaxis until day +90 as recommended by the International Consensus document of the TTS (Transplantation 2013:96:333-360).
- Experimental arm: prophylaxis with valganciclovir and determination of CMV-specific cellular immunity day +15, +30, +45 and +60. Prophylaxis was discontinued when the patient developed CMV-specific cellular immunity. Patients who did not develop CMV specific immunity continue prophylaxis until day +90.
Analysis: The incidence of CMV disease according to the strategy used was calculated using Kaplan-Meier curves that were compared using the log-rank test.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplant Infection||Drug: New profilaxis Drug: Profilaxis recommended||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Clinical Trial, Open, Multicenter Parallel, no Suspension Inferiority Prophylactic Treatment With Valganciclovir in Kidney Transplant CMV-seropositive Cellular Immunity to Develop CD8 + CMV-specific Treatment After Induction Thymoglobulin.|
|Actual Study Start Date :||August 23, 2016|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||August 2019|
Experimental: New profilaxis
Prophylaxis is discontinued when the patient developed CMV-specific cellular immunity.
Drug: New profilaxis
Primary endpoint: 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.
Active Comparator: Profilaxis recommended by TTS
Valganciclovir prophylaxis until day +90 as recommended by the International Consensus document of the TTS.
Drug: Profilaxis recommended
Secondary end points: percentage of patients developing T cell immunity in CMV-specific transplantation after receiving timoglubulina induction and valganciclovir prophylaxis. T cell development inmnunidad CD8 + CMV-specific is defined as production of γ> 0.2 interferon by CD8 + T cells stimulated by CMV-specific CMV antigens (QF reagent).
- Incidence of CMV disease at 12 months after transplantation [ Time Frame: 12 months ]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 criteria for use in clinical trials
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123627
|Contact: Juan Manuel Escandell Moralesemail@example.com|
|Contact: Aurora Paez Vegafirstname.lastname@example.org|
|Hosìtal Universitario Reina Sofia||Recruiting|
|Córdoba, Spain, 14004|
|Contact: Juan Manuel Escandell Morales 0034677906567 email@example.com|
|Contact: Aurora Paez Vega 0034625591566 firstname.lastname@example.org|