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Compares treatment options for Kidney Transplant
Official title Efficacy and Safety of Leymovir Versus Valganciclovir in Prevention of Cytomegalovirus Infection and Cytomegalovirus Disease in Chinese Kidney Transplant Recipients
ClinicalTrials.gov ID: NCT07266467
What this study is testing
What is Letermovir?
Letermovir is an investigational medicine, being studied as a potential treatment for kidney transplant.
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
- the existing anti-CMV drugs mainly include valganciclovir, ganciclovir and foscarnet sodium, all of which act on DNA polymerase (pUL54), making them prone to cross resistance. DNA synthesis in normal cell is also catalyzed by DNA polymerase, which can also inhibit normal cell production, especially in metabolically active bone marrow cells, leading to bone marrow suppression.
- Phase 4: studies an already-approved treatment
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
- \- 1) Age ≥18 years old, gender unlimited. 2) Receiving the first kidney transplant. 3) Be within 0 (ie, day of transplantation) to 7 days...
- 4) Obtain informed consent signed .
You likely can't join if
- 1)Received a previous solid organ transplant or HSCT. 2)Is a multi-organ transplant recipient (eg, kidney-pancreas). Note: Double kidney transplant...
- 3)Has a history of CMV disease or suspected CMV disease within 6 months prior to randomization.
- 4)Has evidence of CMV viremia at any time from the signing of the ICF or the transplant procedure until the randomization period; 5)Has suspected or...
- 6)Is on dialysis or plasmapheresis at the time of randomization. Note: For the purposes of this protocol, dialysis includes hemofiltration...
- 7)Has post-transplant renal function of CrCI 10 mL/min at randomization (measured) locally). For this exclusion criterion, CrCl will be calculated...
- 8)Has Child-Pugh Class C severe hepatic insufficiency at screening. 9)Has both moderate hepatic insufficiency AND moderate-to-severe renal...
See the full eligibility criteria
- \- 1) Age ≥18 years old, gender unlimited. 2) Receiving the first kidney transplant. 3) Be within 0 (ie, day of transplantation) to 7 days (inclusive) post-kidney transplant at the time of randomization.
- 4) Obtain informed consent signed .
- 1)Received a previous solid organ transplant or HSCT. 2)Is a multi-organ transplant recipient (eg, kidney-pancreas). Note: Double kidney transplant recipients (ie, transplant of two kidneys from the same donor to the...
- 3)Has a history of CMV disease or suspected CMV disease within 6 months prior to randomization.
- 4)Has evidence of CMV viremia at any time from the signing of the ICF or the transplant procedure until the randomization period; 5)Has suspected or known hypersensitivity to active or inactive ingredients of LET...
- 6)Is on dialysis or plasmapheresis at the time of randomization. Note: For the purposes of this protocol, dialysis includes hemofiltration. Participant who: (1) has had dialysis or plasmapheresis within 7 days...
- 7)Has post-transplant renal function of CrCI 10 mL/min at randomization (measured) locally). For this exclusion criterion, CrCl will be calculated using the Cockcroft-Gault equation using the most recently obtained and...
- 8)Has Child-Pugh Class C severe hepatic insufficiency at screening. 9)Has both moderate hepatic insufficiency AND moderate-to-severe renal insufficiency at screening.
- Note: Moderate hepatic insufficiency is defined as Child-Pugh Class B. moderate-to-severe renal insufficiency is defined as CrCl \<50 mL/min, as calculated by the Cockcroft-Gault equation, respectively.
- 10)Has any uncontrolled infection on the day of randomization. 11)Has documented positive results for human immunodeficiency virus antibody (HIV-Ab) test at any time prior to randomization, or for hepatitis C virus...
- 12)Requires mechanical ventilation, or is hemodynamically unstable, at the time of randomization.
- 13)Has a history of malignancy 5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or is under evaluation for...
- 14)Is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through at least 90 days following cessation of study therapy.
- 15)Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration...
- 16)laboratory value at screening: hemoglobin \ 5×ULN; Or serum total bilirubin \>2.5×ULN; 17)Has received within 30 days prior to randomization or plans to receive during the study any of the following anti-CMV IgG...
- 18)Has received within 7 days prior to randomization or plans to receive during the study any of the following anti-CMV drug therapy including: LET, GCV, VGCV, Foscarneth, ACV (at doses \>3200 mg PO per day or \>25...
- 19)are expected to receive TCM or herbal treatment during study treatment and within 14 days after study administration; 20)Is currently participating or has participated in a study with an unapproved investigational...
- 21)Has previously participated or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent, or is planning to participate in a study of a CMV vaccine or...
- 22)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.
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, China
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 Xi'an, Shaanxi, China. 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.