StudyFinder
Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients
RECRUITING
18 years and over
Inclusion Criteria:
• Subject or legally authorized representative has provided written informed consent.
• Age ≥ 18 years of age at the time of informed consent.
• 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
• Received a first kidney transplant from a CMV seropositive donor in the past 7 days prior to enrollment
• 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. 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, 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.
Exclusion Criteria:
• 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 (this includes COVID convalescent plasma)
• Currently enrolled in another interventional study that, in the investigator's opinion, could affect evaluation of the safety and/or efficacy outcomes
• Most recent platelet count post-transplant \<25,000/uL
• Most recent ANC performed post-transplant \<1000/uL
• Multi-organ transplant or have undergone prior organ transplant
• Baseline immunodeficiency prior to transplant:
• Known or suspected human immunodeficiency virus (HIV) infection
• Congenital or acquired immunodeficiency
• Unacceptable immunosuppression
• Receipt of desensitization therapy prior to kidney transplant, or
• Receipt of a blood type A, B, or O-incompatible kidney transplant, or
• Receipt or planned receipt of any of the following: belatacept, alemtuzumab, or rituximab
DRUG: Valganciclovir (Pre-emptive CMV Therapy), DRUG: Valganciclovir CMV Prophylaxis
Cytomegalovirus (CMV), Kidney Transplant, Complications, Kidney Diseases
Megan Gish - megan.gish@ucsf.edu
NCT06798909