Kidney Transplant; ComplicationsPhase 3NCT06001320
De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients
A Phase 3 study testing Letermovir 480 mg once daily in people with Kidney Transplant; Complications and CMV, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This study is being done to compare the effectiveness of de novo Letermovir versus valganciclovir in preventing the development of cytomegalovirus viremia or symptomatic disease in African American kidney transplant recipients within the first year after transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant; Complications, CMV
- What is being tested?
- Letermovir 480 mg once daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2023to 1 Sep 2026
- 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
- Kidney transplant recipients
- Male or female age ≥ 18 years old
- African American race
- CMV high risk (D+/R-)
- received valganciclovir for CMV prophylaxis
- Historical Control group:
Who cannot join
- Re-transplantation
- Panel of reactive antibody ≥80% at the time of transplant
- Positive cytotoxic cross match at the time of transplant
- Experimental Group Inclusion Criteria
- Kidney transplant recipients
- Male or female age ≥ 18 years old
Show all 17Show fewer
- African American race
- CMV high risk (D+/R-)
- Ability to provide informed consent before any trial related activities
- Re-transplantation
- Panel of reactive antibody ≥80% at the time of transplant
- Positive cytotoxic cross match at the time of transplant
- Pregnancy and Breastfeeding
- Prisoners
- Patients with hypersensitivity to acyclovir, valacyclovir or any of its components
- Patients with hypersensitivity to Letermovir or any of its components
- If Patients are taking any of these medications: pimozide, ergot alkaloids (ergotamine, dihydroergotamine), or pitavastatin/simvastatin co-administered with cyclosporine, we will work with the prescribing physician to find an appropriate replacement therapy which will not interfere with any study-related interventions. Otherwise, participants will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Historical Controlled, Single Center Open Label Pilot Comparing the Effectiveness and Tolerability of De-novo Initiation of Letermovir Versus Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients
This study is being done to compare the effectiveness of de novo Letermovir versus valganciclovir in preventing the development of cytomegalovirus viremia or symptomatic disease in African American kidney transplant recipients within the first year after transplantation.
There are two arms in the study:
Arm 1: Prophylaxis: This group includes freshly transplanted high risk (CMV D+/R-) African American Kidney recipients who will be on prophylactic Letermovir for 6 month.
Arm 2: Prophylaxis: This group includes high-risk African American kidney transplant recipients who had already completed the 6 month prophylactic course with the standard of care Valganciclovir.
Read the detailed description
Valganciclovir (VGC) is the drug of choice for CMV prophylaxis. Although effective in preventing CMV infections, VGC is commonly associated with profound bone marrow suppression, specifically leukopenia which increases patients' vulnerability to other infections. Moreover, kidney transplant recipients often receive lymphocytic antibody therapy for induction immunosuppression, which further exacerbates the risk of leukopenia in the first 3-6 months after transplantation. The high leukopenia burden makes management of immunosuppression in the post-transplant setting more complex, often necessitating reduction in immunosuppressive agents that increases risk of allograft rejection.
Primary Objective: this study is being done to compare the effectiveness of de novo Letermovir versus the standard of care valganciclovir in preventing the development of cytomegalovirus viremia (defined as CMV PCR > 137 units/ml) or symptomatic disease in AA kidney transplant recipients within the first year after transplantation.
Secondary Objectives: included leukopenia incidence, acute rejection rates, breakthrough CMV rates, mycophenolate dose adjustments, donor-specific antibody formation, and tolerability.
To compare these these two groups the study uses
- Intervention Letermovir: Recipients in this group will be on prophylactic Letermovir 480mg once a day pill started within the first 5 days of post-transplant up until 6 months post-transplant. Given Letermovir has no activity against herpes viruses, solid organ transplant recipients are at risk of herpes simplex viruses. Participants enrolled in this study group will also receive prophylactic acyclovir 400mg twice daily for the duration of their Letermovir treatment. Both Letermovir and study mandated medication (Acyclovir) are already approved for use by the FDA.
- Intervention Valganciclovir- In this group recipients who have historically received the standard of care prophylactic valganciclovir will be assessed retrospectively. Valganciclovir is 450mg once a day pill started with in the first 10 days post-transplant or at the time of discharge after kidney transplant and taken up until 6 month post-transplant. This historical control study group will include high-risk African American kidney transplant recipients identified from prior research studies who were cared for with Valganciclovir in the 5 years prior to the enrollment start for the study group.
Outcomes of these two groups will be compared in 1:1 fashion. The study will attempt to match patients on Letermovir to the historical patients who received valganciclovir, based on age, kidney Donor profile index and the presence of panel of reactive antibodies.
Strategy for CMV Viremia: CMV viremia will be treated with either oral valganciclovir, intravenous ganciclovir or alternative agents, according to AST ID COP (American Society of Transplantation Infectious disease community of practice) guidelines.
- Conditions
- Kidney Transplant; Complications, CMV
- Being tested
- Letermovir 480 mg once daily, Historical/Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letermovir 480 mg once dailyDrug
We will test the study hypothesis in a single center, matched (1:1 fashion) pilot study of Letermovir 480 mg once daily versus historically matched AA kidney transplant recipients who received valganciclovir. We will enroll 30 AA patients over a 12-month period into the Letermovir group and compare outcomes to a historical group of 30 AA kidney transplant recipients who have received valganciclovir prophylaxis (1:1 fashion), for a total of 60 patients. We will attempt to match patients on Letermovir to the historical patients who received valganciclovir, based on age, kidney Donor profile index and the presence of panel of reactive antibodies.
Historical/ControlOther
The control study group will include high-risk African American kidney transplant recipients cared for with Valganciclovir in the 5 years prior to the enrollment start for the study group. This time frame is based upon the current volume of transplants done at VCU. On average 30 liver and/or kidney transplants are done per month. Thus, 5 years should be an adequate time frame to mine enough number of participants to answer our primary research hypothesis.
| Study group | Role | What they receive |
|---|---|---|
| Letermovir group (study group) | Experimental | Letermovir 480 mg once daily Receives: Drug: Letermovir 480 mg once daily |
| Historical Control study group | Other | Historically matched AA kidney transplant recipients who received the standard of care 450mg once a day valganciclovir prophylaxis Receives: Other: Historical/Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cytomegalovirus viremia (defined as CMV PCR > 137 units/ml) or symptomatic disease in AA kidney transplant recipients
The incidence of cytomegalovirus viremia (defined as CMV PCR > 137 units/ml) or symptomatic disease in AA kidney transplant recipients by one year post-transplantation
Measured: up to one year after transplantation
Secondary outcomes (7)
Incidence of Leukopenia (defined as WBC < 2.5 x 103 cells/mm3 beyond the first 2 weeks of transplantation, while on pharmacologic CMV prophylaxis)
The incidence of leukopenia (defined as WBC < 2.5 x 103 cells/mm3 beyond the first 2 weeks of transplantation, while on pharmacologic CMV prophylaxis)- assessed from 2 weeks up to 26weeks post-transplant
Measured: From 2 weeks up to 26 weeks post-transplant
Impact of Pharmacological Prophylaxis on CMV T-Cell immunity up to 1 year post-transplant
CMV T-cell immunity assay, assessed up to 1 year post-transplant. At 12, 26 and 52 weeks post-transplant
Measured: up to 1 Year post-transplant
Incidence of acute kidney allograft rejection up to one year after transplantation
acute kidney allograft rejection up to one year after transplantation
Measured: up to 1 Year post-transplant
Impact of Pharmacologic CMV Prophylaxis on Mycophenolate dosage up to 6 months post-transplant
Changes in mycophenolate dosage (assessed by review of patient's chart) up to 6 months post-transplant
Measured: Up to 6 months post-transplant
Incidence of de novo donor specific antibody formation up to 1 year after transplant
de novo donor specific antibody formation up to one year after transplantation
Measured: up to 1 Year post-transplant
Tolerability of Letermovir in AA kidney transplant recipients up to 6 months post-transplant using a tolerability assessment questionnaire
Tolerability of Letermovir in AA kidney transplant recipient up to 6 months post-transplant (assessed through patient observation, tolerability assessment questionnaire, obtaining medical history and conduction physical examination during visits, receiving an unsolicited complaint from the participant, and an abnormal value or result from a clinical or laboratory evaluation).
Measured: up to 6 months post-transplant
Correlation between CYP3A5*1 and its impact on tacrolimus metabolism and incidence of kidney allograft rejection up to 1 year post-transplant
correlation between CYP3A5*1 and tacrolimus metabolism and incidence of kidney allograft rejection up to one year after transplantation
Measured: up to 1 Year post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start25 Sep 2023
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, Historical Controlled, Single Center Open Label Pilot Study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Gaurav Gupta, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001320
- Sponsor's protocol ID
- HM20027540
- Status last verified
- Sep 2026
- First submitted
- 18 Jul 2023
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Historical Controlled, Single Center Open Label Pilot Comparing the Effectiveness and Tolerability of De-novo Initiation of Letermovir Versus Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT06001320
- Acronym / sponsor ID
- HM20027540
- Conditions
- Kidney Transplant; Complications, CMV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 21 Aug 2023 (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.
This study is being done to compare the effectiveness of de novo Letermovir versus valganciclovir in preventing the development of cytomegalovirus viremia or symptomatic disease in African American kidney transplant recipients within the first year after transplantation.
There are two arms in the study:
Arm 1: Prophylaxis: This group includes freshly transplanted high risk (CMV D+/R-) African American Kidney recipients who will be on prophylactic Letermovir for 6 month.
Arm 2: Prophylaxis: This group includes high-risk African American kidney transplant recipients who had already completed the 6 month prophylactic course with the standard of care Valganciclovir.
Detailed description
Valganciclovir (VGC) is the drug of choice for CMV prophylaxis. Although effective in preventing CMV infections, VGC is commonly associated with profound bone marrow suppression, specifically leukopenia which increases patients' vulnerability to other infections. Moreover, kidney transplant recipients often receive lymphocytic antibody therapy for induction immunosuppression, which further exacerbates the risk of leukopenia in the first 3-6 months after transplantation. The high leukopenia burden makes management of immunosuppression in the post-transplant setting more complex, often necessitating reduction in immunosuppressive agents that increases risk of allograft rejection.
Primary Objective: this study is being done to compare the effectiveness of de novo Letermovir versus the standard of care valganciclovir in preventing the development of cytomegalovirus viremia (defined as CMV PCR > 137 units/ml) or symptomatic disease in AA kidney transplant recipients within the first year after transplantation.
Secondary Objectives: included leukopenia incidence, acute rejection rates, breakthrough CMV rates, mycophenolate dose adjustments, donor-specific antibody formation, and tolerability.
To compare these these two groups the study uses
- Intervention Letermovir: Recipients in this group will be on prophylactic Letermovir 480mg once a day pill started within the first 5 days of post-transplant up until 6 months post-transplant. Given Letermovir has no activity against herpes viruses, solid organ transplant recipients are at risk of herpes simplex viruses. Participants enrolled in this study group will also receive prophylactic acyclovir 400mg twice daily for the duration of their Letermovir treatment. Both Letermovir and study mandated medication (Acyclovir) are already approved for use by the FDA.
- Intervention Valganciclovir- In this group recipients who have historically received the standard of care prophylactic valganciclovir will be assessed retrospectively. Valganciclovir is 450mg once a day pill started with in the first 10 days post-transplant or at the time of discharge after kidney transplant and taken up until 6 month post-transplant. This historical control study group will include high-risk African American kidney transplant recipients identified from prior research studies who were cared for with Valganciclovir in the 5 years prior to the enrollment start for the study group.
Outcomes of these two groups will be compared in 1:1 fashion. The study will attempt to match patients on Letermovir to the historical patients who received valganciclovir, based on age, kidney Donor profile index and the presence of panel of reactive antibodies.
Strategy for CMV Viremia: CMV viremia will be treated with either oral valganciclovir, intravenous ganciclovir or alternative agents, according to AST ID COP (American Society of Transplantation Infectious disease community of practice) guidelines.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional, Historical Controlled, Single Center Open Label Pilot Study
| Arm | Type | Receives |
|---|---|---|
| Letermovir group (study group) | Experimental | Drug: Letermovir 480 mg once dailyLetermovir 480 mg once daily |
| Historical Control study group | Other | Other: Historical/ControlHistorically matched AA kidney transplant recipients who received the standard of care 450mg once a day valganciclovir prophylaxis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Kidney transplant recipients
- Male or female age ≥ 18 years old
- African American race
- CMV high risk (D+/R-)
- received valganciclovir for CMV prophylaxis
Key exclusion criteria (17 listed)
- Re-transplantation
- Panel of reactive antibody ≥80% at the time of transplant
- Positive cytotoxic cross match at the time of transplant
- Experimental Group Inclusion Criteria
- Kidney transplant recipients
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 |
|---|---|---|
| Letermovir 480 mg once dailyWe will test the study hypothesis in a single center, matched (1:1 fashion) pilot study of Letermovir 480 mg once daily versus historically matched AA kidney transplant recipients who received valganciclovir. We will enroll 30 AA patients over a 12-month period into the Letermovir group and compare outcomes to a historical group of 30 AA kidney transplant recipients who have received valganciclovir prophylaxis (1:1 fashion), for a total of 60 patients. We will attempt to match patients on Letermovir to the historical patients who received valganciclovir, based on age, kidney Donor profile index and the presence of panel of reactive antibodies. | Drug | Letermovir group (study group) |
| Historical/ControlThe control study group will include high-risk African American kidney transplant recipients cared for with Valganciclovir in the 5 years prior to the enrollment start for the study group. This time frame is based upon the current volume of transplants done at VCU. On average 30 liver and/or kidney transplants are done per month. Thus, 5 years should be an adequate time frame to mine enough number of participants to answer our primary research hypothesis. | Other | Historical Control study group |
Primary outcome
Incidence of cytomegalovirus viremia (defined as CMV PCR > 137 units/ml) or symptomatic disease in AA kidney transplant recipients
Time frame: up to one year after transplantation
The incidence of cytomegalovirus viremia (defined as CMV PCR > 137 units/ml) or symptomatic disease in AA kidney transplant recipients by one year post-transplantation
7 secondary outcomes
Incidence of Leukopenia (defined as WBC < 2.5 x 103 cells/mm3 beyond the first 2 weeks of transplantation, while on pharmacologic CMV prophylaxis)
Time frame: From 2 weeks up to 26 weeks post-transplant
Impact of Pharmacological Prophylaxis on CMV T-Cell immunity up to 1 year post-transplant
Time frame: up to 1 Year post-transplant
Incidence of acute kidney allograft rejection up to one year after transplantation
Time frame: up to 1 Year post-transplant
Impact of Pharmacologic CMV Prophylaxis on Mycophenolate dosage up to 6 months post-transplant
Time frame: Up to 6 months post-transplant
Incidence of de novo donor specific antibody formation up to 1 year after transplant
Time frame: up to 1 Year post-transplant
Tolerability of Letermovir in AA kidney transplant recipients up to 6 months post-transplant using a tolerability assessment questionnaire
Time frame: up to 6 months post-transplant
Correlation between CYP3A5*1 and its impact on tacrolimus metabolism and incidence of kidney allograft rejection up to 1 year post-transplant
Time frame: up to 1 Year post-transplant
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 23 Sep 2026.
- 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.
Gaurav Gupta, MD principal investigator
Virginia Commonwealth University
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 Letermovir 480 mg once daily in people with Kidney Transplant; Complications and CMV, run by Virginia Commonwealth University at 1 site in United States.
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 17 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 23 Sep 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 United States. 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 cytomegalovirus viremia (defined as CMV PCR > 137 units/ml) or symptomatic disease in AA kidney transplant recipients (time frame: up to one year after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2026.