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El ensayo clínico NCT06958796 (SHIELD) para Citomegalovirus, Trasplante de órganos, Trasplante Renal; Complicaciones, Trasplante de Hígado; Complicaciones, Simultaneous Liver-Kidney Transplantation; Complications está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV) (SHIELD) Fase IV 80 Preventivo
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT06958796 (SHIELD) está diseñado para estudiar la prevención de Citomegalovirus, Trasplante de órganos, Trasplante Renal; Complicaciones, Trasplante de Hígado; Complicaciones, Simultaneous Liver-Kidney Transplantation; Complications. Es un estudio intervencionista de Fase IV. Su estado actual es: reclutando. El estudio se inició el 27 de noviembre de 2025, con el objetivo de reclutar a 80 participantes. Dirigido por Camille N. Kotton, MD, se espera que finalice el 31 de mayo de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 22 de diciembre de 2025.
Resumen
This study is being done to find out if administering CytoGam® after the end of standardly prescribed preventive antiviral treatment can help transplant recipients with a high risk for developing late CMV disease after a liver and/or kidney transplant.
Descripción detallada
This research study is being done to find out if administering CytoGam® after the end of standardly prescribed preventive antiviral treatment can help people with a high risk for developing late CMV disease post-transplant.
Cytomegalovirus (CMV) is a very common virus and in the same family as the viruses that cause herpes, chickenpox, and mononucleosis. Most people become infected with the virus when they come in d...
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Exploratory Use of CMV Immunoglobulin in High Risk (D+R-) Transplant Recipients at the End of Antiviral Prophylaxis to Decrease the Risk of Late CMV Infection
Condiciones médicas
CitomegalovirusTrasplante de órganosTrasplante Renal; ComplicacionesTrasplante de Hígado; ComplicacionesSimultaneous Liver-Kidney Transplantation; ComplicationsPublicaciones
Artículos científicos y trabajos de investigación publicados sobre este estudio clínico:Otros ID del estudio
- SHIELD
- 2024P003592
Número del NCT
Inicio del estudio (real)
2025-11-27
Última actualización
2025-12-22
Fecha de finalización (estimada)
2028-05-31
Inscripción (prevista)
80
Tipo de estudio
Intervencionista
FASE
Fase IV
Estado general
Reclutando
Palabras clave
cytomegalovirus
valganciclovir
organ transplant
immunoglobulin
CMV
High Risk CMV
valganciclovir
organ transplant
immunoglobulin
CMV
High Risk CMV
Objetivo principal
Prevención
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalArm A: CytoGam® Participants assigned to receive CytoGam® will receive an infusion once a month for three months at their study site. The infusion will be completed over an average of about 4 hours; these three visits will last about 5 hours. During these study staff will review concomitant medications and adverse events. Participants will be asked to have blood taken at infusion visits and 2 weeks after an infusion visit to check t...Mostrar más | Cytomegalovirus Immune Globulin Intravenous (Human) monthly for three months The interventional arm will receive Cytomegalovirus Immune Globulin Intravenous (Human) monthly for three months as (150 mg/kg) for 3 consecutive months (Days 0, 28 and 56 +/- 3 days). The non-interventional arm will not receive any intervention. |
Sin intervenciónArm B: Standard of Care Participants assigned to Arm B, will be asked to complete a telephone call visit once a month. During these visits, a member of study staff will review concomitant medications and adverse events. Participants will be asked to have their blood taken every two weeks to check the level of CMV DNA. | N/A |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Number of Participants with Late Clinically Significant CMV Disease | Comparison between treatment groups of number of participants with a blood CMV viral load \>1000 IU/ml at any point during the treatment phase through end of study | Treatment Phase (Day 0) through End of Study (Day 168) |
Number of Participants with Adverse Events Related to CMV | Congregate data of all Adverse Events (including Serious Adverse Events) will be compared between treatment arms. The number and percent of CMV related AEs will be summarized by:
Organ system impacted Relationship to CMV Severity Deaths
Those leading to:
1. Initiation of CMV treatment
2. Hospitalization due to CMV | Events starting after or increasing in severity following initiation of the Treatment Phase (Day 0) through end of study (Day 168) |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Peak CMV DNA Levels | Comparison of peak CMV DNA levels (DNAemia/viremia) between treatment groups using either the Wilcoxon rank-sum test or Student's t-test, depending on the distribution of the data; DNA tests will be completed every 2 weeks throughout the trial and reported in IU/ml | From Enrollment, through the Treatment Phase (Day 0) until the end of study (Day 168) |
Change in CMV DNA Levels Across Study Groups | Trend the change and differences in CMV viral loads over time between groups using a mixed-effects model with biweekly CMV DNA test results | From Enrollment, through the Treatment Phase (Day 0) until the end of study (Day 168) |
Time to First Detectable CMV DNAemia | Time to onset of CMV DNAemia/viremia summarized by treatment group measured by week of onset after day 0 (end of valganciclovir prophylaxis) | Treatment Phase (Day 0) through End of Study (Day 168) |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- High risk pretransplant CMV donor seropositive/recipient seronegative (D+R-) kidney, liver, or simultaneous liver-kidney (SLK) transplant recipients
- Able to do routine blood testing (normal care for transplant recipients)
- Written informed consent obtained from the subject before any trial-related procedures
- Be ≥18 years and ≤75 years of age at time of consent
- Any pre-transplant CMV serologic combinations besides CMV D+/R-
- Multi organ transplants (other than simultaneous liver-kidney transplant (SLK) recipients) or prior history of bone marrow or stem cell transplant
- Lung, heart, small bowel, pancreas, or other non-kidney or non-liver transplant recipients
- Transplant recipients treated for rejection within three months before the end of valganciclovir prophylaxis
- Participation in another interventional clinical trial at time of consent or within 30 days prior to study consent
- Transplant recipients with eGFR <30 ml/min/1.73m2 (as they theoretically could be at higher risk for renal impairment with CMV immunoglobulin), poor transplant organ function (i.e. LFTs > twice the upper limit of normal in liver recipients), or who are on dialysis, or plasmapheresis, or who are relisted for transplant, or who might otherwise at risk of complications at the discretion of the local site investigator.
- Those with a history of severe reaction to CMV immunoglobulin (e.g. CytoGam® or similar) or other human immunoglobulin preparations
- Individuals with a history of selective immunoglobulin A deficiency will be excluded, as they may produce antibodies against immunoglobulin A, leading to potential anaphylactic reactions upon receiving blood products containing immunoglobulin A, such as CMV immunoglobulin (e.g. CytoGam® or similar)
- Any history of acute myocardial infarction (within 12 months of screening), clinically significant arrythmia, or clinically significant ECG abnormality in the opinion of the investigator at time of screening
- History of active or latent tuberculosis (except those who have completed a documented regimen for latent TB treatment) or severe pulmonary disease \[e.g., severe pulmonary hypertension (WHO class IV)\] that in the opinion of the investigator that may preclude their ability to safely tolerate study infusions
- Any history of neurodegenerative disease, including dementia, or stroke with substantial residual disability (modified Rankin score ≥ 3)
- Pregnant or nursing (lactating) women confirmed by human chorionic gonadotropin (hCG) laboratory test.
- Women of childbearing potential unless using a highly effective method of contraception during dosing and for 24 weeks after study treatment. Medically acceptable birth control (contraceptives) includes but are not limited to: surgical sterilization (such as hysterectomy or "tubes tied"), approved hormonal contraceptives (such as birth control pills, patch or ring; Depo-Provera, Depo-Lupron, lmplanon), barrier methods (such as condom or diaphragm), an intrauterine device (IUD), abstinence from sex.
- Any significant history of any treatment nonadherence or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
- Subjects who have any of the following laboratory values: eGFR <30 ml/min/1.73m2 ; Hemoglobin <8.0 g/dL; Platelets <50,000 cells/uL; Absolute neutrophil count <1,000 cells/uL; Total bilirubin >2.5 x upper limit of normal; Alanine aminotransferase (ALT) >5 x upper limit of normal; Aspartate aminotransferase (AST)] >5 x upper limit of normal; CMV IgG negative in donor or positive in recipient
Camille N. Kotton, MD- Centro Médico Suroccidental de la Universidad de Texas
Parte responsable del estudio
Camille N. Kotton, MD, Investigador-patrocinador, Camille N. Kotton, MD, Clinical Director of Transplant Infectious Disease, Massachusetts General Hospital
Contactos centrales del estudio
Contacto: Amelia Stocking, BS, 617-643-4087, [email protected]
Contacto: Camille Kotton, MD, 6177240084, [email protected]
2 Centros del estudio en 1 países
Massachusetts
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
MGH Abdominal Transplant Unit, Contacto, 617-643-4087, [email protected]
Camille Kotton, MD, Investigador principal
Reclutando
Texas
University of Texas Southwestern, Dallas, Texas, 75390, United States
Jarrett Hubbard, BA, Contacto, 214-648-3111, [email protected]
David Wojciechowski, DO, Contacto, (214) 648-3111, [email protected]
David Wojciechowski, DO, Investigador principal
Reclutando