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| Name | Class |
|---|---|
| CSL Behring | INDUSTRY |
The purpose of the study is to assess the incidence and severity of late Cytomegalovirus (CMV) disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and 200 days and after 200 days post-transplant in patients treated with valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant versus valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valcyte | Active Comparator | valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant |
|
| Valcyte then Cytogam | Active Comparator | valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valganciclovir | Drug | Valcyte per package insert guidelines for 200 days post transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Late CMV Disease | Number of any clinically significant late CMV disease, defined as CMV syndrome or tissue-invasive disease occurring after the first 200 days post transplant | after 200 days post-transplant until 2 years post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Early CMV Infection | 100 days | |
| Number of Patients With Cell Mediated Immunity | Positive CMV quantiferon at last follow-up | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39807668 | Derived | Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Valcyte | valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant Valganciclovir: Valcyte per package insert guidelines for 200 days post transplant |
| FG001 | Valcyte Then Cytogam | valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection CMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant Valganciclovir: valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Valcyte - Kidney Transplant | Subjects who received a kidney transplant and assigned to the Valcyte only Treatment arm. |
| BG001 | Valcyte Then Cytogam - Kidney Transplant | Subjects who received a kidney transplant and assigned to the Valcyte then CytogamTreatment arm. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Late CMV Disease | Number of any clinically significant late CMV disease, defined as CMV syndrome or tissue-invasive disease occurring after the first 200 days post transplant | Posted | Count of Participants | Participants | after 200 days post-transplant until 2 years post-transplant |
|
up to 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Valcyte | valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant Valganciclovir: Valcyte per package insert guidelines for 200 days post transplant |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CMV disease | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Fleming | Medical University of South Carolina | 843-792-0312 | fleminj@musc.edu |
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| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077562 | Valganciclovir |
| C045781 | cytomegalovirus-specific hyperimmune globulin |
| ID | Term |
|---|---|
| D015774 | Ganciclovir |
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 |
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| CMV hyperimmune globulin | Biological | 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant |
|
|
| Valganciclovir | Drug | valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant |
|
|
| Renal Function | Renal function will be assessed by an estimated creatinine clearance utilizing the abbreviated Modification of Diet in Renal Disease (MDRD) equation at 6, 12, and 24 months after transplant | 6, 12, and 24 months after transplant |
| Number of Participants With Acute Cellular and/or Antibody Mediated Rejection | 2 years |
| Number of Participants With Opportunistic Infections | 2 years |
| Number of Participants With Asymptomatic CMV Viremia | 2 years |
| Number of Participants With CMV Seroconversions | 2 years |
| BG002 | Valcyte - Liver Transplant | Subjects who received a liver transplant and assigned to the Valcyte only Treatment arm. |
| BG003 | Valcyte Then Cytogam - Liver Transplant | Subjects who received a liver transplant and assigned to the Valcyte then Cytogam Treatment arm. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Retransplant | Count of Participants | Participants |
|
| Weight (kg) | Mean | Standard Deviation | kg |
|
| Pre-emptive | Pre-Emptive applies only to kidney transplant patients. Pre-emptive values were obtained by counting the number of patients who were not on dialysis prior to their kidney transplant. | Count of Participants | Participants |
|
|
|
| Secondary | Number of Patients With Early CMV Infection | Posted | Count of Participants | Participants | 100 days |
|
|
|
| Secondary | Number of Patients With Cell Mediated Immunity | Positive CMV quantiferon at last follow-up | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Renal Function | Renal function will be assessed by an estimated creatinine clearance utilizing the abbreviated Modification of Diet in Renal Disease (MDRD) equation at 6, 12, and 24 months after transplant | Posted | Mean | Full Range | mL/min/1.73m^2 | 6, 12, and 24 months after transplant |
|
|
|
| Secondary | Number of Participants With Acute Cellular and/or Antibody Mediated Rejection | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Number of Participants With Opportunistic Infections | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Number of Participants With Asymptomatic CMV Viremia | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Number of Participants With CMV Seroconversions | Posted | Count of Participants | Participants | 2 years |
|
|
|
| 1 |
| 20 |
| 4 |
| 20 |
| 16 |
| 20 |
| EG001 | Valcyte Then Cytogam | valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection CMV hyperimmune globulin: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant Valganciclovir: valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant | 0 | 20 | 4 | 20 | 20 | 20 |
| Graft loss | Renal and urinary disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| BK infection | Renal and urinary disorders | Systematic Assessment |
|
| Candidiasis | Infections and infestations | Systematic Assessment |
|
| Acute rejection | Renal and urinary disorders | Systematic Assessment |
|
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| Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| GFR at 2 years |
|