RECRUITING

Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients

Conditions

Cytomegalovirus (CMV)Kidney Transplant; Complications Kidney Diseases

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Kidney Transplant Preemptive Therapy or Prophylaxis (KPoP) for CMV Prevention in D+R- Recipients

Quick Facts

Study Start:2025-07-22

Study Completion:2031-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06798909

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject or legally authorized representative has provided written informed consent. 2. Age ≥ 18 years of age at the time of informed consent. 3. Negative for antibody to CMV as assessed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory between 28 days prior to transplant and 7 days post-transplant, but prior to enrollment, and no history of positive CMV serology Immunoglobulin G (IgG) antibody 4. Received a first kidney transplant from a CMV seropositive donor in the past 7 days prior to enrollment 5. Individuals of reproductive (childbearing) potential must have a negative pregnancy test (serum or urine) collected prior to randomization (standard of care (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 1 month after discontinuation of either PET or AP. 6. If male, and not surgically sterile, must agree to practice barrier method of contraception or abstinence from the time of enrollment through 1 month after discontinuation of either PET or AP.	1. In the opinion of the investigator, participants who are unable or unwilling to undergo preemptive therapy protocol (weekly CMV PCR, etc.) 2. Patients who are breastfeeding or planning to breastfeed within 6 months post-transplant 3. Allergy to valganciclovir/ganciclovir or Letermovir 4. Receipt of immunoglobulin or CMV-specific immunoglobulin within the last 3 months (this includes COVID convalescent plasma) 5. Currently enrolled in another interventional study that, in the investigator's opinion, could affect evaluation of the safety and/or efficacy outcomes 6. Most recent platelet count post-transplant \<25,000/uL 7. Most recent ANC performed post-transplant \<1000/uL 8. Multi-organ transplant or have undergone prior organ transplant 9. Baseline immunodeficiency prior to transplant: 1. Known or suspected human immunodeficiency virus (HIV) infection 2. Congenital or acquired immunodeficiency 10. Unacceptable immunosuppression 1. Receipt of desensitization therapy prior to kidney transplant, or 2. Receipt of a blood type A, B, or O-incompatible kidney transplant, or 3. Receipt or planned receipt of any of the following: belatacept, alemtuzumab, or rituximab

Inclusion Criteria

Exclusion Criteria

1. Subject or legally authorized representative has provided written informed consent.
2. Age ≥ 18 years of age at the time of informed consent.
3. Negative for antibody to CMV as assessed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory between 28 days prior to transplant and 7 days post-transplant, but prior to enrollment, and no history of positive CMV serology Immunoglobulin G (IgG) antibody
4. Received a first kidney transplant from a CMV seropositive donor in the past 7 days prior to enrollment
5. Individuals of reproductive (childbearing) potential must have a negative pregnancy test (serum or urine) collected prior to randomization (standard of care (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 1 month after discontinuation of either PET or AP.
6. If male, and not surgically sterile, must agree to practice barrier method of contraception or abstinence from the time of enrollment through 1 month after discontinuation of either PET or AP.

1. In the opinion of the investigator, participants who are unable or unwilling to undergo preemptive therapy protocol (weekly CMV PCR, etc.)
2. Patients who are breastfeeding or planning to breastfeed within 6 months post-transplant
3. Allergy to valganciclovir/ganciclovir or Letermovir
4. Receipt of immunoglobulin or CMV-specific immunoglobulin within the last 3 months (this includes COVID convalescent plasma)
5. Currently enrolled in another interventional study that, in the investigator's opinion, could affect evaluation of the safety and/or efficacy outcomes
6. Most recent platelet count post-transplant \<25,000/uL
7. Most recent ANC performed post-transplant \<1000/uL
8. Multi-organ transplant or have undergone prior organ transplant
9. Baseline immunodeficiency prior to transplant:
1. Known or suspected human immunodeficiency virus (HIV) infection
2. Congenital or acquired immunodeficiency
10. Unacceptable immunosuppression
1. Receipt of desensitization therapy prior to kidney transplant, or
2. Receipt of a blood type A, B, or O-incompatible kidney transplant, or
3. Receipt or planned receipt of any of the following: belatacept, alemtuzumab, or rituximab

Contacts and Locations

Study Contact

Megan Gish

CONTACT

415-476-1985

megan.gish@ucsf.edu

Principal Investigator

Abhijit P. Limaye, MD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco School of Medicine

San Francisco, California, 94117

United States

University of Miami Miller School of Medicine

Miami, Florida, 33136

United States

Emory University School of Medicine

Atlanta, Georgia, 30322

United States

Robert Wood Johnson Health Network Barnabas Health

Livingston, New Jersey, 07039

United States

Medical College of Virginia Commonwealth

Richmond, Virginia, 23219

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

Abhijit P. Limaye, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-22

Study Completion Date2031-06-30

Study Record Updates

Study Start Date2025-07-22

Study Completion Date2031-06-30

Terms related to this study

Additional Relevant MeSH Terms

Cytomegalovirus (CMV)
Kidney Transplant; Complications
Kidney Diseases