Kidney Transplant InfectionPhase 3NCT03123627
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.
A Phase 3 study testing New profilaxis and Profilaxis recommended in people with Kidney Transplant Infection, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Infection
- What is being tested?
- New profilaxis and Profilaxis recommended
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 23 Aug 2016to 21 Oct 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Multivisceral transplants including kidney-pancreas.
- HIV-infected Patients
- Patients who can not comply with the monitoring protocol.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Kidney Transplant Infection
- Being tested
- New profilaxis, Profilaxis recommended
- Keywords
- Cytomegalovirus, Seropositive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New profilaxisDrug
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.
Profilaxis recommendedDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| New profilaxis | Experimental | Prophylaxis is discontinued when the patient developed CMV-specific cellular immunity. Receives: Drug: New profilaxis |
| Profilaxis recommended by TTS | Active comparator | Valganciclovir prophylaxis until day +90 as recommended by the International Consensus document of the TTS. Receives: Drug: Profilaxis recommended |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
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)
Measured: 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start23 Aug 2016
- Primary completion21 Oct 2019
- Study completion21 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123627
- Sponsor's protocol ID
- TIMOVAL
- Status last verified
- Jan 2021
- First submitted
- 19 Apr 2017
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 34228099
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03123627
- Acronym / sponsor ID
- TIMOVAL
- Conditions
- Kidney Transplant Infection
- Keywords
- Cytomegalovirus, Seropositive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 23 Aug 2016 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 21 Oct 2019 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New profilaxis | Experimental | Drug: New profilaxisProphylaxis is discontinued when the patient developed CMV-specific cellular immunity. |
| Profilaxis recommended by TTS | Active comparator | Drug: Profilaxis recommendedValganciclovir prophylaxis until day +90 as recommended by the International Consensus document of the TTS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Renal transplant CMV-Seropositive
- CD8+ Tcell CMV especific pretransplant (CMV-reactive quantiferon pretrasplant)
- > 18 years (adult)
- Receiving Thymoglobulin induction therapy
- Receiving Valganciclovir prophylaxis
Key exclusion criteria (3 listed)
- Multivisceral transplants including kidney-pancreas.
- HIV-infected Patients
- Patients who can not comply with the monitoring protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New profilaxisPrimary 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. | Drug | New profilaxis |
| Profilaxis recommendedSecondary 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). | Drug | Profilaxis recommended by TTS |
Primary outcome
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
2 secondary outcomes
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
Incidence of CMV replication
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Derived from this study: PubMed 34228099Paez-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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Kidney Transplant Infection
RecruitingPhase 2
A Trial to Evaluate the Safety, Tolerability and Efficacy of AIC263029 in Kidney Transplant Recipients With BKV Infection
BK Virus Infection, BKV Infection
Not yet recruitingPhase 3
Prediction and Prevention of Bloodstream Infections After Kidney Transplantation
Kidney Transplant Infection, Bloodstream Infection
Not yet recruitingPhase 4
Antibiotics for Kidney Transplant Recipients
Kidney Transplant, Urinary Tract Infection(UTI)
RecruitingPhase 2
Safety and Tolerability of IDO-1 Inhibition in the Prevention of EBV-related Pathology in EBV Negative Kidney Transplant Recipients Receiving an Organ From EBV Positive Donors
EBV Infections, Kidney Transplant
RecruitingObservational study
Immune Registry for BK in Kidney Transplant Recipients
BK Virus Infection, Kidney Transplant; Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing New profilaxis and Profilaxis recommended in people with Kidney Transplant Infection, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of CMV disease at 12 months after transplantation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03123627, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021; AzTrials last refreshed its copy on 29 Oct 2026.