Cytomegalovirus InfectionsPhase 4(PREVAIL-KT)NCT07430683
Valganciclovir Prophylaxis Versus Preemptive Therapy for Cytomegalovirus in Living Donor Kidney Transplant Recipients
A Phase 4 study testing Valganciclovir Prophylaxis and Preemptive Therapy (CMV PCR Monitoring) in people with Cytomegalovirus Infections, run by University of Guadalajara at 1 site in Mexico.
Trial summary
Cytomegalovirus (CMV) infection remains one of the most frequent infectious complications after kidney transplantation. In intermediate-risk recipients (seropositive, R+ recipient) of living donor kidney transplants, optimal prevention strategies remain debated, particularly in the setting of basiliximab-based… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infections
- What is being tested?
- Valganciclovir Prophylaxis and Preemptive Therapy (CMV PCR Monitoring)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2024to 31 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- -Age ≥18 years.
- -First living-donor kidney transplant.
- -Intermediate CMV risk (recipient seropositive [R+], donor positive or negative [D+/D-]).
- 4-Induction immunosuppression with basiliximab. 5.-Ability to provide written informed consent.
Who cannot join
- -Multi-organ transplant recipients (e.g., pancreas-kidney, liver-kidney).
- -Deceased donor transplant recipients.
- -Primary non-function of the graft.
- -Hyperacute rejection.
- -Death within the first month post-transplant.
- -Early graft loss due to surgical complications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Cytomegalovirus Infection or Disease Using Valganciclovir Prophylaxis Versus Preemptive Therapy in Intermediate-Risk (R+) Living Donor Kidney Transplant Recipients Receiving Basiliximab-Based Immunosuppression: An Open-Label Clinical Trial (PREVAIL-KT)
Cytomegalovirus (CMV) infection remains one of the most frequent infectious complications after kidney transplantation. In intermediate-risk recipients (seropositive, R+ recipient) of living donor kidney transplants, optimal prevention strategies remain debated, particularly in the setting of basiliximab-based induction therapy.
This open-label clinical trial aims to compare the incidence of CMV infection or disease in intermediate-risk (R+) living donor kidney transplant recipients receiving valganciclovir prophylaxis versus a preemptive therapy strategy. All patients receive basiliximab-based immunosuppression as part of standard clinical practice.
Read more
Participants were enrolled between March 1, 2024 and July 31, 2025. Patients are followed for 12 months post-transplantation to assess the primary outcome of CMV infection or disease. Secondary outcomes include graft function, acute rejection episodes, and other infectious complications.
The results of this study may help define the optimal CMV prevention strategy in intermediate-risk living donor kidney transplant recipients under basiliximab-based immunosuppression.
Read the detailed description
Cytomegalovirus (CMV) infection remains one of the most frequent infectious complications after kidney transplantation and is associated with increased morbidity, acute rejection, and impaired graft survival. Recipients at intermediate CMV risk (seropositive recipients, R+) represent a large proportion of living-donor kidney transplant patients; however, the optimal prevention strategy in this population remains controversial.
Two main preventive approaches are currently used: universal antiviral prophylaxis and a preemptive therapy strategy based on viral load monitoring. While both strategies are accepted in clinical practice, comparative evidence in intermediate-risk living donor recipients receiving basiliximab induction therapy is limited, particularly in single-center settings in Mexico.
This single-center, open-label randomized controlled trial was conducted at the Transplant Division of UMAE Hospital de Especialidades, Centro Médico Nacional de Occidente (IMSS), Mexico. Adult recipients undergoing first living-donor kidney transplantation at intermediate CMV risk and receiving basiliximab induction were randomized to either a universal prophylaxis strategy with valganciclovir or a preemptive monitoring-based approach. All participants received standard maintenance immunosuppression and were followed for 12 months after transplantation.
The study aims to compare the effectiveness of these two prevention strategies in reducing CMV infection and disease, as well as evaluating associated hematologic adverse events and acute rejection episodes. The findings are expected to contribute evidence to guide CMV prevention strategies in intermediate-risk kidney transplant recipients in similar healthcare settings.
- Conditions
- Cytomegalovirus Infections
- Being tested
- Valganciclovir Prophylaxis, Preemptive Therapy (CMV PCR Monitoring)
- Keywords
- Cytomegalovirus, Kidney Transplant, Living Donor, Valganciclovir, Preemptive Therapy, Basiliximab
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valganciclovir ProphylaxisDrug
Participants receive Valganciclovir 900 mg orally once daily for 3 months, starting on day 7 post-transplant. Standard maintenance immunosuppression with tacrolimus, mycophenolate mofetil, and prednisone is administered. Participants are followed for 12 months to assess CMV infection, CMV disease, hematologic adverse events, and acute rejection episodes
Preemptive Therapy (CMV PCR Monitoring)Diagnostic test
Participants undergo quantitative CMV PCR monitoring every 15 days for the first 3 months and monthly until month 12. Antiviral therapy with Valganciclovir is initiated if viral load ≥1,000 copies/mL. Standard maintenance immunosuppression with tacrolimus, mycophenolate mofetil, and prednisone is administered. Participants are followed for 12 months to assess CMV infection, CMV disease, hematologic adverse events, and acute rejection episodes.
| Study group | Role | What they receive |
|---|---|---|
| Valganciclovir Prophylaxis | Experimental | Participants receive Valganciclovir 900 mg orally once daily for 3 months, starting on day 7 post-transplant. Standard maintenance immunosuppression with tacrolimus, mycophenolate mofetil, and prednisone is administered. Participants are followed for 12 months to assess CMV infection, CMV disease, hematologic adverse events, and acute rejection episodes Receives: Drug: Valganciclovir Prophylaxis |
| Preemptive Therapy (CMV PCR Monitoring) | Active comparator | Participants undergo quantitative CMV PCR monitoring every 15 days for the first 3 months and monthly until month 12. Antiviral therapy with Valganciclovir is initiated if viral load ≥1,000 copies/mL. Standard maintenance immunosuppression with tacrolimus, mycophenolate mofetil, and prednisone is administered. Participants are followed for 12 months to assess CMV infection, CMV disease, hematologic adverse events, and acute rejection episodes. Receives: Diagnostic Test: Preemptive Therapy (CMV PCR Monitoring) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CMV infection and/or CMV disease
CMV infection is defined as detectable CMV DNAemia by quantitative PCR. CMV disease is defined as CMV DNAemia plus compatible clinical syndrome (e.g., fever, malaise, cytopenias) and/or organ involvement (e.g., pneumonitis, colitis, pancreatitis)
Measured: Within 12 months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Mar 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus InfectionsStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to either valganciclovir prophylaxis or preemptive therapy. Each participant received only one intervention, and outcomes were assessed independently over 12 months
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Mexicano del Seguro Social
- Responsible party
- Sponsor
- Investigators
- Jorge Andrade-Sierra, PhD, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430683
- Sponsor's protocol ID
- R-2024-1301-202
- Acronym
- (PREVAIL-KT)
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andrade-Sierra J, Heredia-Pimentel A, Rojas-Campos E, Ramirez Flores D, Cerrillos-Gutierrez JI, Miranda-Diaz AG, Evangelista-Carrillo LA, Martinez-Martinez P, Jalomo-Martinez B, Gonzalez-Espinoza E, Gomez-Navarro B, Medina-Perez M, Nieves-Hernandez JJ. Cytomegalovirus in renal transplant recipients from living donors with and without valganciclovir prophylaxis and with immunosuppression based on anti-thymocyte globulin or basiliximab. Int J Infect Dis. 2021 Jun;107:18-24. doi: 10.1016/j.ijid.2021.04.032. Epub 2021 Apr 14.
PubMed 33862205Witzke O, Hauser IA, Bartels M, Wolf G, Wolters H, Nitschke M; VIPP Study Group. Valganciclovir prophylaxis versus preemptive therapy in cytomegalovirus-positive renal allograft recipients: 1-year results of a randomized clinical trial. Transplantation. 2012 Jan 15;93(1):61-8. doi: 10.1097/TP.0b013e318238dab3.
PubMed 22094954Witzke O, Nitschke M, Bartels M, Wolters H, Wolf G, Reinke P, Hauser IA, Alshuth U, Kliem V. Valganciclovir Prophylaxis Versus Preemptive Therapy in Cytomegalovirus-Positive Renal Allograft Recipients: Long-term Results After 7 Years of a Randomized Clinical Trial. Transplantation. 2018 May;102(5):876-882. doi: 10.1097/TP.0000000000002024.
PubMed 29166336Fehr T, Cippa PE, Mueller NJ. Cytomegalovirus post kidney transplantation: prophylaxis versus pre-emptive therapy? Transpl Int. 2015 Dec;28(12):1351-6. doi: 10.1111/tri.12629. Epub 2015 Jul 27.
PubMed 26138458Villeneuve C, Rerolle JP, Couzi L, Westeel PF, Etienne I, Esposito L, Kamar N, Buchler M, Thierry A, Marquet P, Monchaud C. The Cost-effectiveness of Valganciclovir Prophylaxis Versus Preemptive Therapy in CMV R+ Kidney Transplant Recipients Over the First Year Posttransplantation. Transplant Direct. 2024 Jul 26;10(8):e1678. doi: 10.1097/TXD.0000000000001678. eCollection 2024 Aug.
PubMed 39076520Reischig T, Vlas T, Kacer M, Pivovarcikova K, Lysak D, Nemcova J, Drenko P, Machova J, Bouda M, Sedivcova M, Kormunda S. A Randomized Trial of Valganciclovir Prophylaxis Versus Preemptive Therapy in Kidney Transplant Recipients. J Am Soc Nephrol. 2023 May 1;34(5):920-934. doi: 10.1681/ASN.0000000000000090. Epub 2023 Feb 2.
PubMed 36749127
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Cytomegalovirus Infection or Disease Using Valganciclovir Prophylaxis Versus Preemptive Therapy in Intermediate-Risk (R+) Living Donor Kidney Transplant Recipients Receiving Basiliximab-Based Immunosuppression: An Open-Label Clinical Trial (PREVAIL-KT)
- ClinicalTrials.gov ID
- NCT07430683
- Acronym / sponsor ID
- (PREVAIL-KT) / R-2024-1301-202
- Conditions
- Cytomegalovirus Infections
- Keywords
- Cytomegalovirus, Kidney Transplant, Living Donor, Valganciclovir, Preemptive Therapy, Basiliximab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Collaborators
- Instituto Mexicano del Seguro Social
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 24 Feb 2026 (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.
Cytomegalovirus (CMV) infection remains one of the most frequent infectious complications after kidney transplantation. In intermediate-risk recipients (seropositive, R+ recipient) of living donor kidney transplants, optimal prevention strategies remain debated, particularly in the setting of basiliximab-based induction therapy.
This open-label clinical trial aims to compare the incidence of CMV infection or disease in intermediate-risk (R+) living donor kidney transplant recipients receiving valganciclovir prophylaxis versus a preemptive therapy strategy. All patients receive basiliximab-based immunosuppression as part of standard clinical practice.
Participants were enrolled between March 1, 2024 and July 31, 2025. Patients are followed for 12 months post-transplantation to assess the primary outcome of CMV infection or disease. Secondary outcomes include graft function, acute rejection episodes, and other infectious complications.
The results of this study may help define the optimal CMV prevention strategy in intermediate-risk living donor kidney transplant recipients under basiliximab-based immunosuppression.
Detailed description
Cytomegalovirus (CMV) infection remains one of the most frequent infectious complications after kidney transplantation and is associated with increased morbidity, acute rejection, and impaired graft survival. Recipients at intermediate CMV risk (seropositive recipients, R+) represent a large proportion of living-donor kidney transplant patients; however, the optimal prevention strategy in this population remains controversial.
Two main preventive approaches are currently used: universal antiviral prophylaxis and a preemptive therapy strategy based on viral load monitoring. While both strategies are accepted in clinical practice, comparative evidence in intermediate-risk living donor recipients receiving basiliximab induction therapy is limited, particularly in single-center settings in Mexico.
This single-center, open-label randomized controlled trial was conducted at the Transplant Division of UMAE Hospital de Especialidades, Centro Médico Nacional de Occidente (IMSS), Mexico. Adult recipients undergoing first living-donor kidney transplantation at intermediate CMV risk and receiving basiliximab induction were randomized to either a universal prophylaxis strategy with valganciclovir or a preemptive monitoring-based approach. All participants received standard maintenance immunosuppression and were followed for 12 months after transplantation.
The study aims to compare the effectiveness of these two prevention strategies in reducing CMV infection and disease, as well as evaluating associated hematologic adverse events and acute rejection episodes. The findings are expected to contribute evidence to guide CMV prevention strategies in intermediate-risk kidney transplant recipients in similar healthcare settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to either valganciclovir prophylaxis or preemptive therapy. Each participant received only one intervention, and outcomes were assessed independently over 12 months
| Arm | Type | Receives |
|---|---|---|
| Valganciclovir Prophylaxis | Experimental | Drug: Valganciclovir ProphylaxisParticipants receive Valganciclovir 900 mg orally once daily for 3 months, starting on day 7 post-transplant. Standard maintenance immunosuppression with tacrolimus, mycophenolate mofetil, and prednisone is administered. Participants are followed for 12 months to assess CMV infection, CMV disease, hematologic adverse events, and acute rejection episodes |
| Preemptive Therapy (CMV PCR Monitoring) | Active comparator | Diagnostic Test: Preemptive Therapy (CMV PCR Monitoring)Participants undergo quantitative CMV PCR monitoring every 15 days for the first 3 months and monthly until month 12. Antiviral therapy with Valganciclovir is initiated if viral load ≥1,000 copies/mL. Standard maintenance immunosuppression with tacrolimus, mycophenolate mofetil, and prednisone is administered. Participants are followed for 12 months to assess CMV infection, CMV disease, hematologic adverse events, and acute rejection episodes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- -Age ≥18 years.
- -First living-donor kidney transplant.
- -Intermediate CMV risk (recipient seropositive [R+], donor positive or negative [D+/D-]).
- 4-Induction immunosuppression with basiliximab. 5.-Ability to provide written informed consent.
Key exclusion criteria (6 listed)
- -Multi-organ transplant recipients (e.g., pancreas-kidney, liver-kidney).
- -Deceased donor transplant recipients.
- -Primary non-function of the graft.
- -Hyperacute rejection.
- -Death within the first month post-transplant.
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 |
|---|---|---|
| Valganciclovir ProphylaxisParticipants receive Valganciclovir 900 mg orally once daily for 3 months, starting on day 7 post-transplant. Standard maintenance immunosuppression with tacrolimus, mycophenolate mofetil, and prednisone is administered. Participants are followed for 12 months to assess CMV infection, CMV disease, hematologic adverse events, and acute rejection episodes | Drug | Valganciclovir Prophylaxis |
| Preemptive Therapy (CMV PCR Monitoring)Participants undergo quantitative CMV PCR monitoring every 15 days for the first 3 months and monthly until month 12. Antiviral therapy with Valganciclovir is initiated if viral load ≥1,000 copies/mL. Standard maintenance immunosuppression with tacrolimus, mycophenolate mofetil, and prednisone is administered. Participants are followed for 12 months to assess CMV infection, CMV disease, hematologic adverse events, and acute rejection episodes. | Diagnostic test | Preemptive Therapy (CMV PCR Monitoring) |
Primary outcome
Incidence of CMV infection and/or CMV disease
Time frame: Within 12 months post-transplant
CMV infection is defined as detectable CMV DNAemia by quantitative PCR. CMV disease is defined as CMV DNAemia plus compatible clinical syndrome (e.g., fever, malaise, cytopenias) and/or organ involvement (e.g., pneumonitis, colitis, pancreatitis)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Background: PubMed 33862205Andrade-Sierra J, Heredia-Pimentel A, Rojas-Campos E, Ramirez Flores D, Cerrillos-Gutierrez JI, Miranda-Diaz AG, Evangelista-Carrillo LA, Martinez-Martinez P, Jalomo-Martinez B, Gonzalez-Espinoza E, Gomez-Navarro B, Medina-Perez M, Nieves-Hernandez JJ. Cytomegalovirus in renal transplant recipients from living donors with and without valganciclovir prophylaxis and with immunosuppression based on anti-thymocyte globulin or basiliximab. Int J Infect Dis. 2021 Jun;107:18-24. doi: 10.1016/j.ijid.2021.04.032. Epub 2021 Apr 14.
- Background: PubMed 22094954Witzke O, Hauser IA, Bartels M, Wolf G, Wolters H, Nitschke M; VIPP Study Group. Valganciclovir prophylaxis versus preemptive therapy in cytomegalovirus-positive renal allograft recipients: 1-year results of a randomized clinical trial. Transplantation. 2012 Jan 15;93(1):61-8. doi: 10.1097/TP.0b013e318238dab3.
- Background: PubMed 29166336Witzke O, Nitschke M, Bartels M, Wolters H, Wolf G, Reinke P, Hauser IA, Alshuth U, Kliem V. Valganciclovir Prophylaxis Versus Preemptive Therapy in Cytomegalovirus-Positive Renal Allograft Recipients: Long-term Results After 7 Years of a Randomized Clinical Trial. Transplantation. 2018 May;102(5):876-882. doi: 10.1097/TP.0000000000002024.
- Background: PubMed 26138458Fehr T, Cippa PE, Mueller NJ. Cytomegalovirus post kidney transplantation: prophylaxis versus pre-emptive therapy? Transpl Int. 2015 Dec;28(12):1351-6. doi: 10.1111/tri.12629. Epub 2015 Jul 27.
- Background: PubMed 39076520Villeneuve C, Rerolle JP, Couzi L, Westeel PF, Etienne I, Esposito L, Kamar N, Buchler M, Thierry A, Marquet P, Monchaud C. The Cost-effectiveness of Valganciclovir Prophylaxis Versus Preemptive Therapy in CMV R+ Kidney Transplant Recipients Over the First Year Posttransplantation. Transplant Direct. 2024 Jul 26;10(8):e1678. doi: 10.1097/TXD.0000000000001678. eCollection 2024 Aug.
- Background: PubMed 36749127Reischig T, Vlas T, Kacer M, Pivovarcikova K, Lysak D, Nemcova J, Drenko P, Machova J, Bouda M, Sedivcova M, Kormunda S. A Randomized Trial of Valganciclovir Prophylaxis Versus Preemptive Therapy in Kidney Transplant Recipients. J Am Soc Nephrol. 2023 May 1;34(5):920-934. doi: 10.1681/ASN.0000000000000090. Epub 2023 Feb 2.
- KDIGO Clinical Practice Guidelines for Kidney TransplantationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jorge Andrade-Sierra, PhD principal investigator
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valganciclovir Prophylaxis and Preemptive Therapy (CMV PCR Monitoring) in people with Cytomegalovirus Infections, run by University of Guadalajara at 1 site in Mexico.
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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2026. 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 Mexico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 infection and/or CMV disease (time frame: Within 12 months post-transplant). 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 NCT07430683, which also lists 6 linked publications.
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 24 Feb 2026.