Clinical Trials

Inclusion Criteria:

• Is a recipient of a primary or secondary allograft kidney.

• Is at least 4 weeks posttransplant and not more than 52 weeks posttransplant at the time of enrollment (Day 1) and is being managed per local standard of care.

  • If on CMV prophylaxis other than LET (eg, VGCV), study LET can be administered concurrently.

  • If on nonstudy oral LET prophylaxis (ie, prescribed by their treating physician), the following criteria must be met

    • The dose of nonstudy oral LET must be the same as the dose of study LET assigned on Day 1 and must be taken at that dose for at least 10 days before Day 1.

    • The participant must stop nonstudy LET (ie, take their last dose) the day before enrollment (Day 1) and must not resume nonstudy LET until the IPK sampling is completed (or early discontinuation of study LET occurs, if applicable).

• Has stable kidney function posttransplant defined as 2 creatinine clearance measurements that are ≥30 mL/min, varying by ≤20%, and ≥7 to ≤28 days apart.

• Has undetectable CMV DNA from a plasma or whole blood sample collected within 14 days prior to enrollment.

• Must be able to take (as assessed by the investigator) LET tablets or oral pellets by mouth, or via G/NG tube (oral pellets only).

• Does not have a condition that may interfere with the absorption of oral medication (eg, vomiting, diarrhea, or a malabsorptive condition) from the day of enrollment (Day 1) until the IPK sampling is completed.

Demographics.

• Is an individual of any sex/gender, <18 years of age at the time of providing documented informed consent or assent, as applicable.

• Weighs ≥2.5 and <40 kg at enrollment (Day 1).

Note: There are no contraceptive requirements for participants assigned male sex at birth

• A participant assigned female sex at birth is eligible to participate if not breastfeeding during the study intervention period and for at least 14 days after the last dose of study intervention.

• A POCBP is eligible to participate if not pregnant and if a negative highly sensitive pregnancy test (urine or serum), as required by local regulations, has been obtained within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. Additional requirements for pregnancy testing during and after study intervention are in Section 8.3.6.

• A POCBP is eligible to participate if they use an acceptable contraceptive method or if they adhere to penile-vaginal intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 5, during the intervention period and for at least 28 days after the last dose of study intervention.

Note: The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recent initiation) in relationship to the first dose of study intervention. Contraceptive use by POCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the local contraception requirements for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed. Medical history, menstrual history, and recent sexual activity should be reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.

• The participant (or participant’s legally acceptable representative) has provided documented informed consent and the participant has provided documented assent, when applicable, for the study.

Exclusion Criteria:

• Has CMV disease or suspected CMV disease between screening and enrollment (see Appendix 11).

• Is on dialysis or plasmapheresis at the time of enrollment. Note: For the purposes of this protocol, dialysis includes hemofiltration. A participant who: (1) is not on dialysis or plasmapheresis at the time of screening; and (2) is expected to remain off dialysis or plasmapheresis may be enrolled, provided that all other inclusion/exclusion criteria are met.

• Has evidence of CMV viremia at any time from screening until the time of enrollment. (Note: Evidence of CMV viremia will include any test result reported as “detectable” including “detectable, not quantifiable,” or “detected” with a numeric value provided by a quantitative assay).

• Has suspected or known hypersensitivity to active or inactive ingredients of LET formulations.

• Has Child-Pugh B or C hepatic insufficiency within 14 days before enrollment (see Appendix 9).

• Has serum AST or ALT >5 x the ULN or serum total bilirubin >2.5 x ULN within 14 days before enrollment.

Note: Participants who meet this exclusion criterion may, at the discretion of the investigator, have repeat testing done 1 time within the screening window. If the repeat value does not meet this criterion, they may continue in the screening process. Only the specific out of range value must be repeated (not the entire panel).

• Is a multi-organ transplant recipient (eg, kidney-pancreas).

• Has any uncontrolled infection on the day of enrollment.

• Requires mechanical ventilation, or is hemodynamically unstable, at the time of enrollment.

• Has received within 30 days before enrollment (Day 1) or plans to receive during the study any of the following:Rifampin and other strong inducers (such as phenytoin, carbamazepine, St John’s wort (Hypericum perforatum), rifabutin and phenobarbital) and moderate inducers such as nafcillin, thioridazine, modafinil, and bosentan.

• Has received CsA within 10 days before enrollment (Day 1) or plans to take CsA from the day of enrollment (Day 1) until the IPK sampling is completed.

• Is taking or plans to take any of the prohibited medications listed in the protocol (see Section 6.5.2).

• Is currently participating in or has participated in an interventional or prevention clinical study with an investigational compound or device from within 30 days prior to Day 1 through the duration of the study.08V7KH Note: Concurrent participation in observational or noninterventional studies may be permitted and should be discussed with the Sponsor before enrollment and through study duration.

• Is expecting to conceive or donate eggs at any time during the study.

• Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study, or interfere with the participant’s participation for the full duration of the study, in the opinion of the investigator.

• Is unable or unwilling, in the opinion of the investigator, to comply with the protocol.

• Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/23/2025. Questions regarding updates should be directed to the study team contact.