Cytomegalovirus (CMV)Phase 3KPoPNCT06798909
Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients
A Phase 3 study testing Valganciclovir (Pre-emptive CMV Therapy) and Valganciclovir CMV Prophylaxis in people with Cytomegalovirus (CMV) and Kidney Transplant; Complications, run by University of California, San Francisco at 8 sites in United States.
Trial summary
This is a prospective, randomized multicenter trial of preemptive therapy (PET) vs. antiviral prophylaxis (AP) for prevention of cytomegalovirus (CMV) disease in adult D+R- kidney transplant recipients (KTR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus (CMV), Kidney Transplant; Complications, Kidney Diseases
- What is being tested?
- Valganciclovir (Pre-emptive CMV Therapy) and Valganciclovir CMV Prophylaxis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 8 sitesUnited States
- Study dates
- 22 Jul 2025to 31 May 2031
- Phase
- Phase 3
- 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
- Subject has provided written informed consent.
- Age ≥ 18 years of age at the time of informed consent.
- Negative for IgG antibody to CMV as assessed in a CLIA-certified laboratory between 28 days prior to transplant and up to 10 days post-transplant but prior to randomization.
- Received a kidney transplant from a CMV seropositive (IgG positive) donor in the past 10 days prior to enrollment
- Individuals of reproductive (childbearing) potential must have a negative pregnancy test (serum or urine) collected prior to randomization (SOC results within 7 days prior to transplant may be used), and must also agree to use a medically approved method of contraception. Acceptable methods include: barrier method, intrauterine device (hormonal or non-hormonal), oral hormonal contraceptives, abstinence from the time of enrollment through until discontinuation of ganciclovir or valganciclovir in either arm during the intervention period.
- NOTE: Individuals of reproductive potential are defined as individuals who have reached menarche and who have not been post-menopausal for at least 12 consecutive months with follicle stimulating hormone (FSH) ≥40 IU/mL or 24 consecutive months if an FSH is not available, i.e., who have had menses within the preceding 24 months, and have not undergone a sterilization procedure (e.g., hysterectomy, bilateral oophorectomy, or salpingectomy).
- If male, must agree to practice a barrier method of contraception or abstinence from the time of enrollment through 3 months after discontinuation of ganciclovir or valganciclovir in either arm during the intervention period.
Who cannot join
- In the opinion of the investigator, participants who are unable or unwilling to undergo preemptive therapy protocol (weekly CMV PCR, etc.)
- Patients who are breastfeeding or planning to breastfeed within 6 months post-transplant
- Allergy to valganciclovir/ganciclovir or Letermovir
- Receipt of immunoglobulin or CMV-specific immunoglobulin within the last 3 months prior to the qualifying CMV IgG serology as described in inclusion criteria #3 (this includes COVID convalescent plasma)
- Currently enrolled or anticipated enrollment in another interventional study that, in the opinion of scientific leadership team, could affect evaluation of the primary safety and/or efficacy outcomes.
- Most recent platelet count post-transplant <25,000/uL
Show all 15Show fewer
- Most recent ANC performed post-transplant <1000/uL
- Multi-organ transplant (except simultaneous kidney-pancreas) within the past 7 days
- Prior or planned receipt of a hematopoietic cell transplant
- Baseline immunodeficiency prior to transplant, including but not limited to:
- Known or suspected HIV infection
- Congenital or acquired immunodeficiency
- Unacceptable immunosuppression
- Receipt of desensitization therapy prior to kidney transplant, or
- Receipt of an ABO-incompatible kidney transplant except A2 to blood type B
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Emory University School of Medicine
Atlanta, Georgia, 30322
Aneesh Mehta, MD, (404) 727-8435, aneesh.mehta@emory.edu
- Not yet recruiting
University of Texas Southwestern
Dallas, Texas, 75390
Ricardo La Hoz, MD, 214-645-6427, ricardo.lahoz@utsouthwestern.edu
Ricardo La Hoz, MD
- Recruiting
Duke University
Durham, North Carolina, 27708
Scott Sanoff, MD, 919-620-5300, Scott.sanoff@duke.edu
Scott Sanoff, MD
- Recruiting
Robert Wood Johnson Health Network Barnabas Health
Livingston, New Jersey, 07039
Francis Weng, MD, (973) 322-5065, francis.weng@rwjbh.org
- Recruiting
University of Miami Miller School of Medicine
Miami, Florida, 33136
Yoichiro Natori, MD, 305-355-5418, yxn138@med.miami.edu
- Not yet recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Sias Scherger, MD, 402-559-4000, sscherger@unmc.edu
Sias Scherger, MD
- Recruiting
Medical College of Virginia Commonwealth
Richmond, Virginia, 23219
Guarav Gupta, MD, 804-828-4104, gaurav.gupta@vcuhealth.org
- Recruiting
University of California, San Francisco School of Medicine
San Francisco, California, 94117
Puneet Sood, MD, MPH, 415-353-1551, puneet.sood@ucsf.edu
About this study
Official title: Kidney Transplant Preemptive Therapy or Prophylaxis (KPoP) for CMV Prevention in D+R- Recipients
This is a prospective, randomized multicenter trial of preemptive therapy (PET) vs. antiviral prophylaxis (AP) for prevention of cytomegalovirus (CMV) disease in adult D+R- kidney transplant recipients (KTR). Patients meeting study eligibility criteria and who have provided informed consent will be randomized (1:1) within 7 days of transplant to receive, in an open label design, either AP with valganciclovir 900 mg orally once daily or letermovir 480 mg orally once daily [both dose adjusted per Food and Drug Administration (FDA) label] for 200 days post-transplant), or PET (central lab weekly plasma polymerase chain reaction (PCR) monitoring for CMV deoxyribonucleic acidemia (DNAemia)) for 100 days post-transplant, with oral valganciclovir 900mg orally twice daily (or renally dosed per FDA label) at onset of CMV DNAemia at any level and continued until plasma CMV DNAemia is negative or below the level of quantitation in two consecutive weekly plasma samples. Study participants will be followed for pre-specified outcomes (clinical, laboratory, immunologic, safety) until withdrawal, death, or study closure, up to a maximum of 5.5 years post-transplant. Approximately 360 participants (180 participants in each group) will be randomized into the study.
Estimated Time to Complete Enrollment: 4 years
- Being tested
- Valganciclovir (Pre-emptive CMV Therapy), Valganciclovir CMV Prophylaxis
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valganciclovir (Pre-emptive CMV Therapy)Drug
Valganciclovir, 900 mg given orally twice daily to Preemptive Therapy group subjects as a PET only after a positive CMV PCR test and stopped after PCR is negative for 2 consecutive weeks.
Valganciclovir CMV ProphylaxisDrug
Valganciclovir, 900 mg given orally once daily to all Prophylaxis group subjects for 200 days post transplantation as prophylaxis.
| Study group | Role | What they receive |
|---|---|---|
| Pre-emptive Therapy | Experimental | 900 mg of Valganciclovir given orally twice daily to Preemptive Therapy subjects upon detection of CMV viremia until plasma PCR is negative on two consecutive weekly PCR test. All dosages adjusted for renal dysfunction. Receives: Drug: Valganciclovir (Pre-emptive CMV Therapy) |
| Prophylaxis | Active comparator | 900 mg of Valganciclovir given orally once daily to subjects for 200 days post transplantation. All dosages adjusted for renal dysfunction. Receives: Drug: Valganciclovir CMV Prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of endpoint committee (EC)-confirmed CMV disease (either syndrome or end-organ) by 1-year post-transplant.
Measured: Within 1-year post-transplant
Secondary outcomes (6)
Non-inferiority of PET (within a 10% margin) vs AP for EC-confirmed CMV disease by 1-year post-transplant, contingent on failure to meet the primary superiority endpoint.
Although the study sample size is powered to detect the superiority of one preventive strategy compared to the other, it is possible that the two approaches may have similar efficacy with respect to prevention of CMV disease. Therefore, should there be insufficient evidence to conclude superiority of one of the approaches, a key Secondary Outcome is a non-inferiority assessment of preemptive therapy to prophylaxis, assuming a non-inferiority margin of 10%. This margin is based on what is known about the effectiveness of the two approaches as published in literature and the potential that the two strategies could be similarly efficacious in preventing CMV disease. The success rate for the prophylaxis group is estimated to be ~80% based on a systematic review and meta-analysis with hypothesized success rates for the preemptive group expected to be higher.
Measured: by 1-year post-transplant
Proportion of participants with investigator-determined CMV disease
Measured: by 1-year post transplant
Time in days to biopsy-proven acute rejection (BIPAR)
Measured: From date of randomization until the date of BIPAR from any cause, assessed up to 5.5 years
Time in days to graft loss
Measured: From date of randomization until the date of graft loss from any cause, assessed up to 5.5 years
Time in days to death
Measured: From date of randomization until the date of death from any cause, assessed up to 5.5 years
Mean estimated glomerular filtration rate (eGFR) in mL/min/1.73m2 at 1, 2, 3, and 4-years post-transplant
Measured: 1, 2, 3, and 4-years post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start22 Jul 2025
- Primary completion30 Nov 2030 (estimated)
- Study completion31 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus (CMV)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abhijit P. Limaye, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798909
- Sponsor's protocol ID
- STUDY00020695
- Other IDs
- 1R01AI184205-01
- Acronym
- KPoP
- Status last verified
- Oct 2026
- First submitted
- 17 Jan 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Limaye AP, Budde K, Humar A, Vincenti F, Kuypers DRJ, Carroll RP, Stauffer N, Murata Y, Strizki JM, Teal VL, Gilbert CL, Haber BA. Letermovir vs Valganciclovir for Prophylaxis of Cytomegalovirus in High-Risk Kidney Transplant Recipients: A Randomized Clinical Trial. JAMA. 2023 Jul 3;330(1):33-42. doi: 10.1001/jama.2023.9106.
PubMed 37279999Kotton CN, Kumar D, Caliendo AM, Huprikar S, Chou S, Danziger-Isakov L, Humar A; The Transplantation Society International CMV Consensus Group. The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation. Transplantation. 2018 Jun;102(6):900-931. doi: 10.1097/TP.0000000000002191.
PubMed 29596116
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kidney Transplant Preemptive Therapy or Prophylaxis (KPoP) for CMV Prevention in D+R- Recipients
- ClinicalTrials.gov ID
- NCT06798909
- Acronym / sponsor ID
- KPoP / STUDY00020695
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 30 Nov 2030 (estimated)
- Study completion
- 31 May 2031 (estimated)
- First posted
- 29 Jan 2025 (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 is a prospective, randomized multicenter trial of preemptive therapy (PET) vs. antiviral prophylaxis (AP) for prevention of cytomegalovirus (CMV) disease in adult D+R- kidney transplant recipients (KTR). Patients meeting study eligibility criteria and who have provided informed consent will be randomized (1:1) within 7 days of transplant to receive, in an open label design, either AP with valganciclovir 900 mg orally once daily or letermovir 480 mg orally once daily [both dose adjusted per Food and Drug Administration (FDA) label] for 200 days post-transplant), or PET (central lab weekly plasma polymerase chain reaction (PCR) monitoring for CMV deoxyribonucleic acidemia (DNAemia)) for 100 days post-transplant, with oral valganciclovir 900mg orally twice daily (or renally dosed per FDA label) at onset of CMV DNAemia at any level and continued until plasma CMV DNAemia is negative or below the level of quantitation in two consecutive weekly plasma samples. Study participants will be followed for pre-specified outcomes (clinical, laboratory, immunologic, safety) until withdrawal, death, or study closure, up to a maximum of 5.5 years post-transplant. Approximately 360 participants (180 participants in each group) will be randomized into the study.
Estimated Time to Complete Enrollment: 4 years
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-emptive Therapy | Experimental | Drug: Valganciclovir (Pre-emptive CMV Therapy)900 mg of Valganciclovir given orally twice daily to Preemptive Therapy subjects upon detection of CMV viremia until plasma PCR is negative on two consecutive weekly PCR test. All dosages adjusted for renal dysfunction. |
| Prophylaxis | Active comparator | Drug: Valganciclovir CMV Prophylaxis900 mg of Valganciclovir given orally once daily to subjects for 200 days post transplantation. All dosages adjusted for renal dysfunction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject has provided written informed consent.
- Age ≥ 18 years of age at the time of informed consent.
- Negative for IgG antibody to CMV as assessed in a CLIA-certified laboratory between 28 days prior to transplant and up to 10 days post-transplant but prior to randomization.
- Received a kidney transplant from a CMV seropositive (IgG positive) donor in the past 10 days prior to enrollment
- Individuals of reproductive (childbearing) potential must have a negative pregnancy test (serum or urine) collected prior to randomization (SOC results within 7 days prior to transplant may be used), and must also agree to use a medically approved method of contraception. Acceptable methods include: barrier method, intrauterine device (hormonal or non-hormonal), oral hormonal contraceptives, abstinence from the time of enrollment through until discontinuation of ganciclovir or valganciclovir in either arm during the intervention period.
Key exclusion criteria (15 listed)
- In the opinion of the investigator, participants who are unable or unwilling to undergo preemptive therapy protocol (weekly CMV PCR, etc.)
- Patients who are breastfeeding or planning to breastfeed within 6 months post-transplant
- Allergy to valganciclovir/ganciclovir or Letermovir
- Receipt of immunoglobulin or CMV-specific immunoglobulin within the last 3 months prior to the qualifying CMV IgG serology as described in inclusion criteria #3 (this includes COVID convalescent plasma)
- Currently enrolled or anticipated enrollment in another interventional study that, in the opinion of scientific leadership team, could affect evaluation of the primary safety and/or efficacy outcomes.
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 (Pre-emptive CMV Therapy)Valganciclovir, 900 mg given orally twice daily to Preemptive Therapy group subjects as a PET only after a positive CMV PCR test and stopped after PCR is negative for 2 consecutive weeks. | Drug | Pre-emptive Therapy |
| Valganciclovir CMV ProphylaxisValganciclovir, 900 mg given orally once daily to all Prophylaxis group subjects for 200 days post transplantation as prophylaxis. | Drug | Prophylaxis |
Primary outcome
Incidence of endpoint committee (EC)-confirmed CMV disease (either syndrome or end-organ) by 1-year post-transplant.
Time frame: Within 1-year post-transplant
6 secondary outcomes
Non-inferiority of PET (within a 10% margin) vs AP for EC-confirmed CMV disease by 1-year post-transplant, contingent on failure to meet the primary superiority endpoint.
Time frame: by 1-year post-transplant
Proportion of participants with investigator-determined CMV disease
Time frame: by 1-year post transplant
Time in days to biopsy-proven acute rejection (BIPAR)
Time frame: From date of randomization until the date of BIPAR from any cause, assessed up to 5.5 years
Time in days to graft loss
Time frame: From date of randomization until the date of graft loss from any cause, assessed up to 5.5 years
Time in days to death
Time frame: From date of randomization until the date of death from any cause, assessed up to 5.5 years
Mean estimated glomerular filtration rate (eGFR) in mL/min/1.73m2 at 1, 2, 3, and 4-years post-transplant
Time frame: 1, 2, 3, and 4-years post-transplant
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 2 Nov 2026.
- Background: PubMed 37279999Limaye AP, Budde K, Humar A, Vincenti F, Kuypers DRJ, Carroll RP, Stauffer N, Murata Y, Strizki JM, Teal VL, Gilbert CL, Haber BA. Letermovir vs Valganciclovir for Prophylaxis of Cytomegalovirus in High-Risk Kidney Transplant Recipients: A Randomized Clinical Trial. JAMA. 2023 Jul 3;330(1):33-42. doi: 10.1001/jama.2023.9106.
- Background: PubMed 29596116Kotton CN, Kumar D, Caliendo AM, Huprikar S, Chou S, Danziger-Isakov L, Humar A; The Transplantation Society International CMV Consensus Group. The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation. Transplantation. 2018 Jun;102(6):900-931. doi: 10.1097/TP.0000000000002191.
- 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.
Abhijit P. Limaye, MD principal investigator
University of California, San Francisco
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Valganciclovir (Pre-emptive CMV Therapy) and Valganciclovir CMV Prophylaxis in people with Cytomegalovirus (CMV) and Kidney Transplant; Complications, run by University of California, San Francisco at 8 sites 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 7 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
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?
Contact Megan Gish (415-476-1985, megan.gish@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of endpoint committee (EC)-confirmed CMV disease (either syndrome or end-organ) by 1-year post-transplant. (time frame: Within 1-year 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 NCT06798909, which also lists 2 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 2 Nov 2026.