Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT06001320
Status:
RECRUITING
Last Update Posted:
2025-10-08
First Post:
2023-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000588473', 'term': 'letermovir'}, {'id': 'D055991', 'term': 'Health Records, Personal'}], 'ancestors': [{'id': 'D008499', 'term': 'Medical Records'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Interventional, Historical Controlled, Single Center Open Label Pilot Study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-06', 'studyFirstSubmitDate': '2023-07-18', 'studyFirstSubmitQcDate': '2023-08-14', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of cytomegalovirus viremia (defined as CMV PCR > 137 units/ml) or symptomatic disease in AA kidney transplant recipients', 'timeFrame': 'up to one year after transplantation', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Incidence of Leukopenia (defined as WBC < 2.5 x 103 cells/mm3 beyond the first 2 weeks of transplantation, while on pharmacologic CMV prophylaxis)', 'timeFrame': 'From 2 weeks up to 26 weeks post-transplant', 'description': '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'}, {'measure': 'Impact of Pharmacological Prophylaxis on CMV T-Cell immunity up to 1 year post-transplant', 'timeFrame': 'up to 1 Year post-transplant', 'description': 'CMV T-cell immunity assay, assessed up to 1 year post-transplant. At 12, 26 and 52 weeks post-transplant'}, {'measure': 'Incidence of acute kidney allograft rejection up to one year after transplantation', 'timeFrame': 'up to 1 Year post-transplant', 'description': 'acute kidney allograft rejection up to one year after transplantation'}, {'measure': 'Impact of Pharmacologic CMV Prophylaxis on Mycophenolate dosage up to 6 months post-transplant', 'timeFrame': 'Up to 6 months post-transplant', 'description': "Changes in mycophenolate dosage (assessed by review of patient's chart) up to 6 months post-transplant"}, {'measure': 'Incidence of de novo donor specific antibody formation up to 1 year after transplant', 'timeFrame': 'up to 1 Year post-transplant', 'description': 'de novo donor specific antibody formation up to one year after transplantation'}, {'measure': 'Tolerability of Letermovir in AA kidney transplant recipients up to 6 months post-transplant using a tolerability assessment questionnaire', 'timeFrame': 'up to 6 months post-transplant', 'description': '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).'}, {'measure': 'Correlation between CYP3A5*1 and its impact on tacrolimus metabolism and incidence of kidney allograft rejection up to 1 year post-transplant', 'timeFrame': 'up to 1 Year post-transplant', 'description': 'correlation between CYP3A5\\*1 and tacrolimus metabolism and incidence of kidney allograft rejection up to one year after transplantation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Transplant; Complications', 'CMV']}, 'descriptionModule': {'briefSummary': 'This study is being done to compare the effectiveness of de novo Letermovir versus valganciclovir in preventing the development of cytomegalovirus viremia or symptomatic disease in African American kidney transplant recipients within the first year after transplantation.\n\nThere are two arms in the study:\n\nArm 1: Prophylaxis: This group includes freshly transplanted high risk (CMV D+/R-) African American Kidney recipients who will be on prophylactic Letermovir for 6 month.\n\nArm 2: Prophylaxis: This group includes high-risk African American kidney transplant recipients who had already completed the 6 month prophylactic course with the standard of care Valganciclovir.', 'detailedDescription': "Valganciclovir (VGC) is the drug of choice for CMV prophylaxis. Although effective in preventing CMV infections, VGC is commonly associated with profound bone marrow suppression, specifically leukopenia which increases patients' vulnerability to other infections. Moreover, kidney transplant recipients often receive lymphocytic antibody therapy for induction immunosuppression, which further exacerbates the risk of leukopenia in the first 3-6 months after transplantation. The high leukopenia burden makes management of immunosuppression in the post-transplant setting more complex, often necessitating reduction in immunosuppressive agents that increases risk of allograft rejection.\n\nPrimary Objective: this study is being done to compare the effectiveness of de novo Letermovir versus the standard of care valganciclovir in preventing the development of cytomegalovirus viremia (defined as CMV PCR \\> 137 units/ml) or symptomatic disease in AA kidney transplant recipients within the first year after transplantation.\n\nSecondary Objectives: included leukopenia incidence, acute rejection rates, breakthrough CMV rates, mycophenolate dose adjustments, donor-specific antibody formation, and tolerability.\n\nTo compare these these two groups the study uses\n\n* Intervention Letermovir: Recipients in this group will be on prophylactic Letermovir 480mg once a day pill started within the first 5 days of post-transplant up until 6 months post-transplant. Given Letermovir has no activity against herpes viruses, solid organ transplant recipients are at risk of herpes simplex viruses. Participants enrolled in this study group will also receive prophylactic acyclovir 400mg twice daily for the duration of their Letermovir treatment. Both Letermovir and study mandated medication (Acyclovir) are already approved for use by the FDA.\n* Intervention Valganciclovir- In this group recipients who have historically received the standard of care prophylactic valganciclovir will be assessed retrospectively. Valganciclovir is 450mg once a day pill started with in the first 10 days post-transplant or at the time of discharge after kidney transplant and taken up until 6 month post-transplant. This historical control study group will include high-risk African American kidney transplant recipients identified from prior research studies who were cared for with Valganciclovir in the 5 years prior to the enrollment start for the study group.\n\nOutcomes of these two groups will be compared in 1:1 fashion. The study 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.\n\nStrategy 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Historical Control group:\n\nInclusion Criteria\n\n1. Kidney transplant recipients\n2. Male or female age ≥ 18 years old\n3. African American race\n4. CMV high risk (D+/R-)\n5. received valganciclovir for CMV prophylaxis\n\nHistorical Control group:\n\nExclusion\n\n1. Re-transplantation\n2. Panel of reactive antibody ≥80% at the time of transplant\n3. Positive cytotoxic cross match at the time of transplant\n\nExperimental Group Inclusion Criteria\n\n1. Kidney transplant recipients\n2. Male or female age ≥ 18 years old\n3. African American race\n4. CMV high risk (D+/R-)\n5. Ability to provide informed consent before any trial related activities\n\nExclusion Criteria\n\n1. Re-transplantation\n2. Panel of reactive antibody ≥80% at the time of transplant\n3. Positive cytotoxic cross match at the time of transplant\n4. Pregnancy and Breastfeeding\n5. Prisoners\n6. Patients with hypersensitivity to acyclovir, valacyclovir or any of its components\n7. Patients with hypersensitivity to Letermovir or any of its components\n8. 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.'}, 'identificationModule': {'nctId': 'NCT06001320', 'briefTitle': 'De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'HM20027540'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Letermovir group (study group)', 'description': 'Letermovir 480 mg once daily', 'interventionNames': ['Drug: Letermovir 480 mg once daily']}, {'type': 'OTHER', 'label': 'Historical Control study group', 'description': 'Historically matched AA kidney transplant recipients who received the standard of care 450mg once a day valganciclovir prophylaxis', 'interventionNames': ['Other: Historical/Control']}], 'interventions': [{'name': 'Letermovir 480 mg once daily', 'type': 'DRUG', 'description': '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 30 AA patients over a 12-month period into the Letermovir group and compare outcomes to a historical group of 30 AA kidney transplant recipients who have received valganciclovir prophylaxis (1:1 fashion), for a total of 60 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.', 'armGroupLabels': ['Letermovir group (study group)']}, {'name': 'Historical/Control', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Historical Control study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23219', 'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lauren K Wallace, MS', 'role': 'CONTACT', 'email': 'cctrctgov@vcu.edu'}, {'name': 'Gaurav Gupta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Idris Yakubu, Pharm.D', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'VCU Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'centralContacts': [{'name': 'Idris Yakubu, PharmD', 'role': 'CONTACT', 'email': 'idris.yakubu@vcuhealth.org', 'phone': '804-828-6286'}, {'name': 'Gelila Abebe', 'role': 'CONTACT', 'email': 'gelila.abebe@vcuhealth.org'}], 'overallOfficials': [{'name': 'Gaurav Gupta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}