Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407232
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-05-06
Brief Title:
Letermovir Prevymis for CMV in Kidney and Pancreas Transplant Recipients
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
An Interventional Study of Letermovir for Secondary Prophylaxis After Treatment of Cytomegalovirus Infection in High Risk DR- Kidney and KidneyPancreas Transplant Recipients
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to assess how effective letermovir is in preventing recurrence of cytomegalovirus CMV infection in adult kidney or kidneypancreas transplant recipients who are UW Health patients Participants will be in the study for about 6 months
Detailed Description:
Study Population Patients over 18 years of age who have undergone kidney or simultaneous kidneypancreas transplant and are high-risk CMV serostatus DR- at time of transplant who develop CMV viremia that necessitates treatment per our institutional protocol enrolled in our CMV stewardship monitoring initiative and demonstrate proven or presumptive lack of cell-mediated immunity either by CMI testing or risk factor screening
Patients will be converted from treatment with ganciclovir derivatives to letermovir 480 mg tablet taken orally once daily when the viral load via SOC weekly monitoring is 500 IUmL This differs from SOC which only allows conversion to secondary prophylactic treatment after CMV is no longer detected on PCR for 2 consecutive weeks Thus liberalization of conversion threshold will allow for reduced exposure to valganciclovir via reduced duration of therapy allowing relief of the myelosuppressive toxicity and creates an environment conducive to CMI
The primary objective is to assess the efficacy of letermovir as secondary prophylaxis after treatment of CMV infection
Primary hypothesis letermovir will be associated with reduced duration of valganciclovir treatment and reduced incidence of recurrent viremia
Primary endpoint valganciclovir treatment time will be measured recurrence will be quantified as number of distinct episodes of any cytomegalovirus replication 1000 IUmL after withdrawal of secondary prophylaxis per previous literature
The secondary objective is to detect the development of cytomegalovirus-specific cell-mediated immunity as determined by a positive result using the Eurofins-Viracor CMV inSIGHTTM T Cell Immunity Testing per manufacturer specifications
Secondary hypothesis letermovir will be associated with increased development of cytomegalovirus-specific cell-mediated immunity when compared to a literature-based control
Secondary endpoint development of cytomegalovirus-specific cell-mediated immunity as determined by a positive result using the Eurofins-Viracor CMV inSIGHTTM T Cell Immunity Testing per manufacturer specifications at the following timepoints letermovir initiation Day 0 and monthly through completion of secondary prophylaxis with a minimum requirement of TCIP at secondary prophylaxis completion
Patients will be converted from treatment with ganciclovir derivatives to letermovir 480 mg tablet taken orally once daily when the viral load via SOC weekly monitoring is 500 IUmL This differs from SOC which only allows conversion to secondary prophylactic treatment after CMV is no longer detected on PCR for 2 consecutive weeks Thus liberalization of conversion threshold will allow for reduced exposure to valganciclovir via reduced duration of therapy allowing relief of the myelosuppressive toxicity and creates an environment conducive to CMI
The primary objective is to assess the efficacy of letermovir as secondary prophylaxis after treatment of CMV infection
Primary hypothesis letermovir will be associated with reduced duration of valganciclovir treatment and reduced incidence of recurrent viremia
Primary endpoint valganciclovir treatment time will be measured recurrence will be quantified as number of distinct episodes of any cytomegalovirus replication 1000 IUmL after withdrawal of secondary prophylaxis per previous literature
The secondary objective is to detect the development of cytomegalovirus-specific cell-mediated immunity as determined by a positive result using the Eurofins-Viracor CMV inSIGHTTM T Cell Immunity Testing per manufacturer specifications
Secondary hypothesis letermovir will be associated with increased development of cytomegalovirus-specific cell-mediated immunity when compared to a literature-based control
Secondary endpoint development of cytomegalovirus-specific cell-mediated immunity as determined by a positive result using the Eurofins-Viracor CMV inSIGHTTM T Cell Immunity Testing per manufacturer specifications at the following timepoints letermovir initiation Day 0 and monthly through completion of secondary prophylaxis with a minimum requirement of TCIP at secondary prophylaxis completion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| A561000 | OTHER | None | None |
| Protocol Version 42424 | OTHER | None | None |
| 235208 | OTHER | OnCore ID | None |