Letermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients

Cytomegalovirus Infections Clinical Trial

Official title: An Interventional Study of Letermovir for Secondary Prophylaxis After Treatment of Cytomegalovirus Infection in High Risk (D+/R-) Kidney and Kidney/Pancreas Transplant Recipients

Status Not yet recruiting

Clinical Trial Summary

This study is designed to assess how effective letermovir is in preventing recurrence of cytomegalovirus (CMV) infection in adult kidney or kidney/pancreas transplant recipients who are UW Health patients. Participants will be in the study for about 6 months.

Clinical Trial Description

Study Population: Patients over 18 years of age who have undergone kidney or simultaneous kidney/pancreas transplant and are high-risk CMV serostatus (D+/R-) 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 IU/mL. 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 (val)ganciclovir treatment and reduced incidence of recurrent viremia.

• Primary endpoint: (val)ganciclovir treatment time will be measured; recurrence will be quantified as number of distinct episodes of any cytomegalovirus replication > 1000 IU/mL 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. ;

Related Conditions & MeSH terms

• Communicable Diseases
• Cytomegalovirus Infections
• Infections
• Kidney Transplant Infection
• Pancreas Transplant

• NCT number: NCT06407232
• Study type: Interventional
• Source: University of Wisconsin, Madison
• Contact: Margaret Jorgenson, PharmD, BCTXP
• Phone: (608) 262-2122
• Email: mrgebarski@wisc.edu
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2024
• Completion date: June 2026