- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06001320
De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Trans Recip
Historical Controlled, Single Center Open Label Pilot Comparing the Effectiveness and Tolerability of De-novo Initiation of Letermovir Versus Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Intervention: Letermovir prophylaxis. Prophylaxis is once daily dose of Letermovier starting Day 1 of post-transplant up until 6 months post-transplant.
Participants enrolled in this study will also receive prophylactic acyclovir 400mg twice daily for the duration of their Letermovir treatment.
Strategy for CMV Viremia: CMV viremia will be treated with either oral valganciclovir, intravenous ganciclovir or alternative agents, according to AST ID COP (American Society of Transplantation Infectious disease community of practice) guidelines.
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Idris Yakubu, PharmD
- Phone Number: 804-828-6286
- Email: idris.yakubu@vcuhealth.org
Study Contact Backup
- Name: Gelila Abebe
- Email: gelila.abebe@vcuhealth.org
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23219
- Recruiting
- VCU Medical Center
-
Principal Investigator:
- Gaurav Gupta, MD
-
Contact:
- Lauren K Wallace, MS
- Email: cctrctgov@vcu.edu
-
Sub-Investigator:
- Idris Yakubu, Pharm.D
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Historical Control group:
Inclusion Criteria
- Kidney transplant recipients
- Male or female age ≥ 18 years old
- African American race
- CMV high risk (D+/R-)
- received valganciclovir for CMV prophylaxis
Historical Control group:
Exclusion
- Re-transplantation
- Panel of reactive antibody ≥80% at the time of transplant
- Positive cytotoxic cross match at the time of transplant
Experimental Group Inclusion Criteria
- Kidney transplant recipients
- Male or female age ≥ 18 years old
- African American race
- CMV high risk (D+/R-)
- Ability to provide informed consent before any trial related activities
Exclusion Criteria
- Re-transplantation
- Panel of reactive antibody ≥80% at the time of transplant
- Positive cytotoxic cross match at the time of transplant
- Pregnancy and Breastfeeding
- Prisoners
- Patients with hypersensitivity to acyclovir, valacyclovir or any of its components
- Patients with hypersensitivity to Letermovir or any of its components
- If Patients are taking any of these medications: pimozide, ergot alkaloids (ergotamine, dihydroergotamine), or pitavastatin/simvastatin co-administered with cyclosporine, we will work with the prescribing physician to find an appropriate replacement therapy which will not interfere with any study-related interventions. Otherwise, participants will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Letermovir group (study group)
Letermovir 480 mg once daily
|
We will test the study hypothesis in a single center, matched (1:1 fashion) pilot study of Letermovir 480 mg once daily versus historically matched AA kidney transplant recipients who received valganciclovir.
We will enroll 50 AA patients over a 12-month period into the Letermovir group and compare outcomes to a historical group of 50 AA kidney transplant recipients who have received valganciclovir prophylaxis (1:1 fashion), for a total of 100 patients.
We will attempt to match patients on Letermovir to the historical patients who received valganciclovir, based on age, kidney Donor profile index and the presence of panel of reactive antibodies.
|
Other: Historically matched AA kidney transplant recipients who received valganciclovir
Compare outcomes to a historical group of 50 AA kidney transplant recipients who have received valganciclovir prophylaxis
|
The control study group will include high-risk African American kidney transplant recipients cared for with Valganciclovir in the 5 years prior to the enrollment start for the study group.
This time frame is based upon the current volume of transplants done at VCU.
On average 30 liver and/or kidney transplants are done per month.
Thus, 5 years should be an adequate time frame to mine enough number of participants to answer our primary research hypothesis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of cytomegalovirus viremia (defined as CMV PCR > 137 units/ml) or symptomatic disease in AA kidney transplant recipients
Time Frame: up to one year after transplantation
|
The incidence of cytomegalovirus viremia (defined as CMV PCR > 137 units/ml) or symptomatic disease in AA kidney transplant recipients by one year post-transplantation
|
up to one year after transplantation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Leukopenia (defined as WBC < 2.5 x 103 cells/mm3 beyond the first 2 weeks of transplantation, while on pharmacologic CMV prophylaxis)
Time Frame: From 2 weeks up to 26 weeks post-transplant
|
The incidence of leukopenia (defined as WBC < 2.5 x 103 cells/mm3 beyond the first 2 weeks of transplantation, while on pharmacologic CMV prophylaxis)- assessed from 2 weeks up to 26weeks post-transplant
|
From 2 weeks up to 26 weeks post-transplant
|
Impact of Pharmacological Prophylaxis on CMV T-Cell immunity up to 1 year post-transplant
Time Frame: up to 1 Year post-transplant
|
CMV T-cell immunity assay, assessed up to 1 year post-transplant.
At 12, 26 and 52 weeks post-transplant
|
up to 1 Year post-transplant
|
Incidence of acute kidney allograft rejection up to one year after transplantation
Time Frame: up to 1 Year post-transplant
|
acute kidney allograft rejection up to one year after transplantation
|
up to 1 Year post-transplant
|
Impact of Pharmacologic CMV Prophylaxis on Mycophenolate dosage up to 6 months post-transplant
Time Frame: Up to 6 months post-transplant
|
Changes in mycophenolate dosage (assessed by review of patient's chart) up to 6 months post-transplant
|
Up to 6 months post-transplant
|
Incidence of de novo donor specific antibody formation up to 1 year after transplant
Time Frame: up to 1 Year post-transplant
|
de novo donor specific antibody formation up to one year after transplantation
|
up to 1 Year post-transplant
|
Tolerability of Letermovir in AA kidney transplant recipients up to 6 months post-transplant, using a tolerability assessment questionnaire
Time Frame: up to 6 months post-transplant
|
Tolerability of Letermovir in AA kidney transplant recipient up to 6 months post-transplant (assessed through patient observation, tolerability assessment questionnaire, obtaining medical history and conduction physical examination during visits, receiving an unsolicited complaint from the participant, and an abnormal value or result from a clinical or laboratory evaluation).
|
up to 6 months post-transplant
|
Correlation between CYP3A5*1 and its impact on tacrolimus metabolism and incidence of kidney allograft rejection up to 1 year post-transplant
Time Frame: up to 1 Year post-transplant
|
correlation between CYP3A5*1 and tacrolimus metabolism and incidence of kidney allograft rejection up to one year after transplantation
|
up to 1 Year post-transplant
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gaurav Gupta, MD, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20027540
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on CMV
-
St George's, University of LondonSt George's University Hospitals NHS Foundation TrustCompletedCMV | Congenital Cmv | Maternal Infections Affecting Fetus or Newborn | Shedding VirusUnited Kingdom
-
Grupo Espanol de trasplantes hematopoyeticos y...Not yet recruiting
-
QIAGEN Gaithersburg, IncTerminated
-
Medical University of South CarolinaTakedaRecruitingCMV | Transplant ComplicationUnited States
-
Meridian Bioscience, Inc.Completed
-
University Hospital, LimogesUniversity Hospital, LilleCompleted
-
Imperial College LondonWithdrawnAllogeneic Stem Cell Transplantation | CMV Reactivation | Autologous CMV Specific CD8+ T CellsUnited Kingdom
-
Fundación para la Investigación del Hospital Clínico...Completed
-
Hospital Israelita Albert EinsteinRecruiting
Clinical Trials on Letermovir 480 mg once daily
-
Otsuka Pharmaceutical Co., Ltd.Completed
-
Kowa Company, Ltd.Recruiting
-
Kowa Company, Ltd.Completed
-
Inflazyme Pharmaceuticals LtdCompleted
-
Johnson & Johnson Pharmaceutical Research & Development...TerminatedAtopic DermatitisUnited States
-
Kowa Company, Ltd.Completed
-
National Institute of Allergy and Infectious Diseases...Merck Sharp & Dohme LLCCompletedHIV Infections | Cytomegalovirus | CMVUnited States
-
Maruho Co., Ltd.Completed
-
Basilea PharmaceuticaCompletedUrothelial CarcinomaUnited Kingdom, Korea, Republic of, Italy, Canada, France, Spain, Germany, United States, Hungary, Australia, Poland, Switzerland, Czechia, Austria
-
Novartis PharmaceuticalsTerminatedAsthmaGermany, Belgium, South Africa, United States, Russian Federation, France, Slovakia, Spain, Thailand, Czechia, Greece, Argentina, Peru, United Kingdom, Bulgaria, Turkey, Hungary, Vietnam, Philippines, Colombia, Chile