- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03123627
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Córdoba, Spain, 14004
- Hosìtal Universitario Reina Sofia
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Renal transplant CMV-Seropositive
- CD8+ Tcell CMV especific pretransplant (CMV-reactive quantiferon pretrasplant)
- > 18 years (adult)
- Receiving Thymoglobulin induction therapy
- Receiving Valganciclovir prophylaxis
- Written informed consent for trial entry
Exclusion Criteria:
- Multivisceral transplants including kidney-pancreas.
- HIV-infected Patients
- Patients who can not comply with the monitoring protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: New profilaxis
Prophylaxis is discontinued when the patient developed CMV-specific cellular immunity.
|
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.
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Active Comparator: Profilaxis recommended by TTS
Valganciclovir prophylaxis until day +90 as recommended by the International Consensus document of the TTS.
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
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Secondary Outcome Measures
Outcome Measure |
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
Time Frame: 12 months
|
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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12 months
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Incidence of CMV replication
Time Frame: 12 months
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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)
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12 months
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TIMOVAL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
IPD Sharing Time Frame
IPD Sharing Access Criteria
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).
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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