Letermovir vs Valganciclovir in CMV R+ Kidney Transplant
A legfontosabb adatok
- Hol
- San Antonio (Egyesült Államok)A helyszín megnézése
- Fázis
- 4. fázis
Helyszínek itt: Egyesült Államok
- University HospitalSan Antonio, Egyesült ÁllamokContact: Elisabeth Kincaide, PharmDNo longer taking part
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Elisabeth Kincaide
- Azonosító
- NCT07571135
- A regiszteradat frissítve
- 2026. május 8.
- Eredeti leírás
The purpose of this study is to find out whether letermovir can help prevent cytomegalovirus (CMV) infection in kidney transplant recipients who are CMV seropositive. To do this, researchers will compare patients who received letermovir with a group of historical patients who received valganciclovir ("mini dose"). Both groups will be on CMV prophylaxis drug for 90 days post-transplant.A teljes eredeti leírásKevesebb
Letermovir Versus Valganciclovir for 90 Days in CMV Seropositive Kidney Transplant Recipients: Results of a Single-center Experience.
The purpose of this study is to find out whether letermovir can help prevent cytomegalovirus (CMV) infection in kidney transplant recipients who are CMV seropositive. To do this, researchers will compare patients who received letermovir with a group of historical patients who received valganciclovir ("mini dose"). Both groups will be on CMV prophylaxis drug for 90 days post-transplant.
The main question the study wants to answer is:
• Does letermovir work as well as valganciclovir in preventing CMV infections during the first 12 months after a kidney transplant?
The study will also look at other important questions:
* Is letermovir easier for patients to tolerate than valganciclovir? * How long does it take for a CMV infection to appear in each group? * Are there differences in "breakthrough" CMV infections between the two medications? * For patients who develop CMV that becomes resistant to treatment, are the resistance patterns different between the two groups
Bevonási feltételek: ≥18 years old; Kidney transplant recipient with documented CMV IgG seropositive status (R+) within 90 days prior to transplant; Males agree to use contraception and refraining from donating sperm for 290 days post-treatment initiation; Females of child-bearing potential agree to follow contraception guidance for 290 days post-treatment initiation.
Kizáró feltételek: Multiorgan organ transplant; Received previous solid organ transplant or HSCT; Unable to take oral medications; Documented HBsAg or detectable HCV RNA 90 days prior to enrollment or HCV+ donor; Received any anti-CMV drug treatment within 7 days prior to enrollment; Current user of recreational or illicit drugs or alcohol dependence; History of CMV disease prior to enrollment; Previously participated in a letermovir study or any other study with CMV investigational agents; Uncontrolled infections at the time of enrollment; Known or suspected hypersensitivity to active or inactive ingredients from letermovir or acyclovir formulations; Child-Pugh Class C severe hepatic insufficiency; Hemodynamically unstable or on mechanical ventilation at the time of enrollment; Pregnant or breastfeeding or planning to be pregnant, breastfeeding or donating eggs during study period and 90 days post cessation; On dialysis or plasmapheresis at the time of enrollment; Currently participating or has participated in a study with an unapproved compound of device within 28 days or 5 half-lives of this study; Contraindications per letermovir or acyclovir package insert: patients on pimozide, ergot alkaloids; or pitavastatin and simvastatin when co-administered with cyclosporine.