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Prevention study for Cytomegalovirus (CMV)
Official title Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients
ClinicalTrials.gov ID: NCT06798909
What this study is testing
What is Valganciclovir (Pre-emptive CMV Therapy)?
Valganciclovir (Pre-emptive CMV Therapy) is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for cytomegalovirus (cmv).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject or legally authorized representative 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 7 days post-transplant but...
- Received a kidney transplant from a CMV seropositive (IgG positive) 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 (SOC...
You likely can't join if
- 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 or anticipated enrollment in another treatment study that, in the opinion of scientific leadership team, could affect evaluation...
- Most recent platelet count post-transplant \<25,000/uL
See the full eligibility criteria
- Subject or legally authorized representative 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 7 days post-transplant but prior to randomization.
- Received a kidney transplant from a CMV seropositive (IgG positive) 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 (SOC results within 7 days prior to transplant may be used), and must also agree...
- 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...
- 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 or anticipated enrollment in another treatment study that, in the opinion of scientific leadership team, could affect evaluation of the primary safety and/or how well it works outcomes.
- Most recent platelet count post-transplant \<25,000/uL
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Livingston, New Jersey, United States
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Miami, Florida, United States; Atlanta, Georgia, United States; Livingston, New Jersey, United States; Richmond, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.