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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New profilaxis | Experimental | Prophylaxis is discontinued when the patient developed CMV-specific cellular immunity. |
|
| Profilaxis recommended by TTS | Active Comparator | Valganciclovir prophylaxis until day +90 as recommended by the International Consensus document of the TTS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New profilaxis | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of CMV disease at 12 months after transplantation | 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who recover CMV-specific CD8+ T-cell immunity in the posttransplantation period after receiving thymoglobulin induction therapy and valganciclovir prophylaxis | CMV-specific CD8+ T-cell immunity will be defined using the QF-CMV technique as IFN-γ production equal to or greater than 0.2 IU/mL following stimulation of CD8+ T cells by CMV antigens (QF-CMV "Reactive").CMV replication was considered asymptomatic when it was not accompanied by CMV disease (CMV syndrome or CMV disease) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hosìtal Universitario Reina Sofia | Córdoba | 14004 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34228099 | Derived | Paez-Vega A, Gutierrez-Gutierrez B, Aguera ML, Facundo C, Redondo-Pachon D, Suner M, Lopez-Oliva MO, Yuste JR, Montejo M, Galeano-Alvarez C, Ruiz-San Millan JC, Los-Arcos I, Hernandez D, Fernandez-Ruiz M, Munoz P, Valle-Arroyo J, Cano A, Rodriguez-Benot A, Crespo M, Rodelo-Haad C, Lobo-Acosta MA, Garrido-Gracia JC, Vidal E, Guirado L, Cantisan S, Torre-Cisneros J; TIMOVAL Study Group. Immunoguided Discontinuation of Prophylaxis for Cytomegalovirus Disease in Kidney Transplant Recipients Treated With Antithymocyte Globulin: A Randomized Clinical Trial. Clin Infect Dis. 2022 Mar 9;74(5):757-765. doi: 10.1093/cid/ciab574. |
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Deidentified participant data.
Who can access the data: Data will be made available only to researchers whose proposed use of the data has been approved by the steering committee.
Types of analyses: Data will be available for a specified purpose to be communicated in writing to Dr Julián Torre-Cisneros or Dr Sara Cantisán.
Mechanisms of data availability: Data will be made available only with a signed data access agreement.
Any additional restrictions: The steering committee has the ultimate decision in approving or denying sample sharing.
beginning date: 07-01-2021, end date: 30-06-2022
Data will be made available after the request is approved by the steering committee (J Torre-Cisneros, A Páez-Vega, S Cantisán).
Requests should be submitted in writing to Dr. Julián Torre-Cisneros (julian.torre.sspa@juntadeandalucia.es) or Dr Sara Cantisán (sacanti@hotmail.com).
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| Profilaxis recommended | Drug | 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). |
|
| 12 months |
| Incidence of CMV replication | CMV replication was defined as >1500 IU/mL in plasma or >5000 IU/mL in whole blood. CMV replication was considered asymptomatic when it was not accompanied by CMV disease (CMV syndrome or CMV disease) | 12 months |