Back to resultsA Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation
Primary Purpose
Cytomegalovirus Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Valganciclovir CMV Prophylaxis
Valganciclovir (Pre-emptive CMV Therapy)
Ganciclovir
Sponsored by
About this trial
This is an interventional prevention trial for Cytomegalovirus Infections
Eligibility Criteria
Inclusion Criteria:
- primary or secondary renal allograft within preceding 14 days;
- IgG seropositive for CMV;
- receiving immunosuppressive therapy.
Exclusion Criteria:
- active CMV infection;
- current/history of malignancy;
- acute steroid resistant rejection episode since transplantation.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Valganciclovir Cytomegalovirus (CMV) Prophylaxis
Pre-emptive CMV Therapy
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants With Active Cytomegalovirus (CMV) Infection Within 12 Months
Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Percentage of Participants With CMV Disease Within 12 Months Including CMV Syndrome and Tissue Invasive Disease
CMV disease comprises the two components of CMV syndrome as well as CMV tissue invasive disease. CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced >50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN). CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid [DNA] by immunostaining or hybridization, respectively), cerebral spinal fluid [CSF]) and/or relevant symptoms or signs of organ dysfunction.
Urine Proteomic Pattern at Month 12
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. Urine proteomic pattern was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Percentage of Participants With Graft Loss at Month 84
Secondary Outcome Measures
Percentage of Participants With CMV Syndrome Within 12 Months
CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced >50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN).
Percentage of Participants With CMV Tissue Invasive Disease Within 12 Months
CMV tissue invasive disease was defined as viremia: PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid [DNA] by immunostaining or hybridization, respectively), cerebral spinal fluid [CSF]) and/or relevant symptoms or signs of organ dysfunction.
Time to Occurrence of First Viremia Within 12 Months
Viremia was defined as plasma PCR ≥ 400 copies/ml.
Viral Burden at Viremia
Time-weighted area under the curve (AUC) of the polymerase chain reaction (PCR). Viremia was defined as plasma PCR ≥ 400 copies/ml.
Creatinine Clearance at Month 12
Creatinine clearance was estimated using the Cockcroft-Gault formula.
Percentage of Participants With at Least One Treated and Biopsy-Proven Acute Rejection Episode Within 12 Months
Days of Hospitalization
Relationship Between Proteomics Pattern and Graft Survival
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of CKD273, CMV, and nephropathy was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Relationship Between Proteomics Pattern and Participant Survival
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of CKD273, CMV, and nephropathy was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Proteomics Parameter: CKD273
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of CKD273 was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Proteomics Parameter: CMV
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of CMV was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Proteomics Parameter: Nephropathy
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of nephropathy was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Percentage of Participants Surviving at Month 12
Percentage of Participants With Graft Survival at Month 12
Percentage of Participants With Leukopenia Within 12 Months
Leukopenia: white blood cell (WBC) of < 3,500/microlitre (μL) and < 1,000/μL
Percentage of Participants With Neutropenia Within 12 Months
Neutropenia: absolute neutrophil count (ANC) < 750/μL within 12 months.
Percentage of Participants With Any Opportunistic Infection Within 12 Months
Percentage of Participants With Post-Transplant Diabetes Mellitus
Percentage of Participants With Active CMV Infections Not Responding to Valganciclovir or IV Ganciclovir Treatment
Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84
Viremia (active CMV Infection) was defined as PCR ≥ 400 copies/ml.
Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84
CMV disease comprises the two components of CMV syndrome as well as CMV tissue invasive disease. CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced >50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN). CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid [DNA] by immunostaining or hybridization, respectively), cerebral spinal fluid [CSF]) and/or relevant symptoms or signs of organ dysfunction.
Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84
CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced >50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN).
Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84
CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid [DNA] by immunostaining or hybridization, respectively), cerebral spinal fluid [CSF]) and/or relevant symptoms or signs of organ dysfunction.
Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84
Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84
CMV disease comprises the two components of CMV syndrome as well as CMV tissue invasive disease. CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced >50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN). CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid [DNA] by immunostaining or hybridization, respectively), cerebral spinal fluid [CSF]) and/or relevant symptoms or signs of organ dysfunction.
Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84
Number of Participants Who Died From Months 24 to Month 84
Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84
Number of Participants Who Had Lost Their Transplant up to Month 84
Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84
Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84
Kaplan-Meier Estimate of the Percentage of Participants (With Versus Without Active CMV Infection) on Valganciclovir CMV Prophylaxis With First Occurrence of Graft Loss at Month 84
An analysis for the time to first occurrence of graft loss within month 84 (by means of Kaplan-Meier analysis) was done for all patients who suffered at least once from acute CMV infection (CMV viremia) during this study versus all patients who did not suffer from acute CMV infection (CMV viremia) during the study. Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Kaplan-Meier Estimate of the Percentage of Participants (With Versus Without Active CMV Infection) on Pre-emptive CMV Therapy With First Occurrence of Graft Loss at Month 84
An analysis for the time to first occurrence of graft loss within month 84 (by means of Kaplan-Meier analysis) was done for all patients who suffered at least once from acute CMV infection (CMV viremia) during this study versus all patients who did not suffer from acute CMV infection (CMV viremia) during the study. Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Number of Participants Who Had Lost Their Transplant or Died up to Month 84
Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
Creatinine Clearance at Month 24 and Every 12 Months up to Month 84
Creatinine Clearance estimated by Cockcroft-Gault formula.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00372229
Brief Title
A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation
Official Title
A Randomized Trial Comparing Valcyte CMV Prophylaxis Versus Pre-emptive Therapy After Renal Transplantation Using Proteomics for Monitoring of Graft Alteration
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This 2 arm study will compare the efficacy of 100 days of Valcyte (900mg po daily) prophylaxis with that of no prophylaxis, under the condition of pre-emptive therapy of active CMV infection, in CMV positive renal transplant recipients. The influence of the two prevention concepts on the occurrence of direct and indirect effects of active CMV infections will be compared. The anticipated time on study treatment is 3 months-1 year, and the target sample size is 100-500 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
299 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Valganciclovir Cytomegalovirus (CMV) Prophylaxis
Arm Type
Experimental
Arm Title
Pre-emptive CMV Therapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Valganciclovir CMV Prophylaxis
Other Intervention Name(s)
Valcyte
Intervention Description
900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
Intervention Type
Drug
Intervention Name(s)
Valganciclovir (Pre-emptive CMV Therapy)
Other Intervention Name(s)
Valcyte
Intervention Description
If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function. If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
Intervention Type
Drug
Intervention Name(s)
Ganciclovir
Intervention Description
If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
Primary Outcome Measure Information:
Title
Percentage of Participants With Active Cytomegalovirus (CMV) Infection Within 12 Months
Description
Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Time Frame
Up to 12 months
Title
Percentage of Participants With CMV Disease Within 12 Months Including CMV Syndrome and Tissue Invasive Disease
Description
CMV disease comprises the two components of CMV syndrome as well as CMV tissue invasive disease. CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced >50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN). CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid [DNA] by immunostaining or hybridization, respectively), cerebral spinal fluid [CSF]) and/or relevant symptoms or signs of organ dysfunction.
Time Frame
Up to 12 months
Title
Urine Proteomic Pattern at Month 12
Description
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. Urine proteomic pattern was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Time Frame
Up to 12 months
Title
Percentage of Participants With Graft Loss at Month 84
Time Frame
Up to 84 months
Secondary Outcome Measure Information:
Title
Percentage of Participants With CMV Syndrome Within 12 Months
Description
CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced >50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN).
Time Frame
Up to 12 months
Title
Percentage of Participants With CMV Tissue Invasive Disease Within 12 Months
Description
CMV tissue invasive disease was defined as viremia: PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid [DNA] by immunostaining or hybridization, respectively), cerebral spinal fluid [CSF]) and/or relevant symptoms or signs of organ dysfunction.
Time Frame
Up to 12 months
Title
Time to Occurrence of First Viremia Within 12 Months
Description
Viremia was defined as plasma PCR ≥ 400 copies/ml.
Time Frame
Up to 12 months
Title
Viral Burden at Viremia
Description
Time-weighted area under the curve (AUC) of the polymerase chain reaction (PCR). Viremia was defined as plasma PCR ≥ 400 copies/ml.
Time Frame
Up to 12 months
Title
Creatinine Clearance at Month 12
Description
Creatinine clearance was estimated using the Cockcroft-Gault formula.
Time Frame
Up to 12 months
Title
Percentage of Participants With at Least One Treated and Biopsy-Proven Acute Rejection Episode Within 12 Months
Time Frame
Up to 12 months
Title
Days of Hospitalization
Time Frame
Up to 12 months
Title
Relationship Between Proteomics Pattern and Graft Survival
Description
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of CKD273, CMV, and nephropathy was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Time Frame
Up to 12 months
Title
Relationship Between Proteomics Pattern and Participant Survival
Description
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of CKD273, CMV, and nephropathy was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Time Frame
Up to 12 months
Title
Proteomics Parameter: CKD273
Description
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of CKD273 was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Time Frame
Up to 12 months
Title
Proteomics Parameter: CMV
Description
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of CMV was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Time Frame
Up to 12 months
Title
Proteomics Parameter: Nephropathy
Description
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of nephropathy was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Time Frame
Up to 12 months
Title
Percentage of Participants Surviving at Month 12
Time Frame
Up to 12 months
Title
Percentage of Participants With Graft Survival at Month 12
Time Frame
Up to 12 months
Title
Percentage of Participants With Leukopenia Within 12 Months
Description
Leukopenia: white blood cell (WBC) of < 3,500/microlitre (μL) and < 1,000/μL
Time Frame
Up to 12 months
Title
Percentage of Participants With Neutropenia Within 12 Months
Description
Neutropenia: absolute neutrophil count (ANC) < 750/μL within 12 months.
Time Frame
Up to 12 months
Title
Percentage of Participants With Any Opportunistic Infection Within 12 Months
Time Frame
Up to 12 months
Title
Percentage of Participants With Post-Transplant Diabetes Mellitus
Time Frame
Up to 12 months
Title
Percentage of Participants With Active CMV Infections Not Responding to Valganciclovir or IV Ganciclovir Treatment
Description
Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Time Frame
Up to 12 months
Title
Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84
Description
Viremia (active CMV Infection) was defined as PCR ≥ 400 copies/ml.
Time Frame
From Month 24 to Month 84
Title
Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84
Description
CMV disease comprises the two components of CMV syndrome as well as CMV tissue invasive disease. CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced >50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN). CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid [DNA] by immunostaining or hybridization, respectively), cerebral spinal fluid [CSF]) and/or relevant symptoms or signs of organ dysfunction.
Time Frame
From Month 24 to Month 84
Title
Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84
Description
CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced >50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN).
Time Frame
From Month 24 to Month 84
Title
Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84
Description
CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid [DNA] by immunostaining or hybridization, respectively), cerebral spinal fluid [CSF]) and/or relevant symptoms or signs of organ dysfunction.
Time Frame
From Month 24 to Month 84
Title
Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84
Description
Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Time Frame
From Month 24 to Month 84
Title
Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84
Description
CMV disease comprises the two components of CMV syndrome as well as CMV tissue invasive disease. CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced >50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN). CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid [DNA] by immunostaining or hybridization, respectively), cerebral spinal fluid [CSF]) and/or relevant symptoms or signs of organ dysfunction.
Time Frame
From Month 24 to Month 84
Title
Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84
Time Frame
From Month 24 to Month 84
Title
Number of Participants Who Died From Months 24 to Month 84
Time Frame
From Month 24 to Month 84
Title
Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84
Time Frame
From Month 24 to Month 84
Title
Number of Participants Who Had Lost Their Transplant up to Month 84
Time Frame
From Month 24 to Month 84
Title
Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84
Time Frame
From Month 24 to Month 84
Title
Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84
Time Frame
From Month 24 to Month 84
Title
Kaplan-Meier Estimate of the Percentage of Participants (With Versus Without Active CMV Infection) on Valganciclovir CMV Prophylaxis With First Occurrence of Graft Loss at Month 84
Description
An analysis for the time to first occurrence of graft loss within month 84 (by means of Kaplan-Meier analysis) was done for all patients who suffered at least once from acute CMV infection (CMV viremia) during this study versus all patients who did not suffer from acute CMV infection (CMV viremia) during the study. Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Time Frame
Up to 84 months
Title
Kaplan-Meier Estimate of the Percentage of Participants (With Versus Without Active CMV Infection) on Pre-emptive CMV Therapy With First Occurrence of Graft Loss at Month 84
Description
An analysis for the time to first occurrence of graft loss within month 84 (by means of Kaplan-Meier analysis) was done for all patients who suffered at least once from acute CMV infection (CMV viremia) during this study versus all patients who did not suffer from acute CMV infection (CMV viremia) during the study. Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Time Frame
Up to 84 months
Title
Number of Participants Who Had Lost Their Transplant or Died up to Month 84
Time Frame
From Month 24 to Month 84
Title
Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84
Time Frame
From Month 24 to Month 84
Title
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
Time Frame
From Month 24 to Month 84
Title
Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
Time Frame
From Month 24 to Month 84
Title
Creatinine Clearance at Month 24 and Every 12 Months up to Month 84
Description
Creatinine Clearance estimated by Cockcroft-Gault formula.
Time Frame
From Month 24 to Month 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
primary or secondary renal allograft within preceding 14 days;
IgG seropositive for CMV;
receiving immunosuppressive therapy.
Exclusion Criteria:
active CMV infection;
current/history of malignancy;
acute steroid resistant rejection episode since transplantation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Aachen
ZIP/Postal Code
52057
Country
Germany
City
Berlin
ZIP/Postal Code
12203
Country
Germany
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Bremen
ZIP/Postal Code
28205
Country
Germany
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
City
Essen
ZIP/Postal Code
45122
Country
Germany
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Hann. Münden
ZIP/Postal Code
34346
Country
Germany
City
Hannover
ZIP/Postal Code
30625
Country
Germany
City
Jena
ZIP/Postal Code
07747
Country
Germany
City
Köln
ZIP/Postal Code
50937
Country
Germany
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
City
Lübeck
ZIP/Postal Code
23562
Country
Germany
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
City
München
ZIP/Postal Code
81675
Country
Germany
City
Münster
ZIP/Postal Code
48149
Country
Germany
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
33861738
Citation
Mazzola P, Schaeffeler E, Witzke O, Nitschke M, Kliem V, Zortel M, Wagner EM, Schwab M, Hauser IA. No association of genetic variants in TLR4, TNF-alpha, IL10, IFN-gamma, and IL37 in cytomegalovirus-positive renal allograft recipients with active CMV infection-Subanalysis of the prospective randomised VIPP study. PLoS One. 2021 Apr 16;16(4):e0246118. doi: 10.1371/journal.pone.0246118. eCollection 2021.
Results Reference
derived
PubMed Identifier
29166336
Citation
Witzke O, Nitschke M, Bartels M, Wolters H, Wolf G, Reinke P, Hauser IA, Alshuth U, Kliem V. Valganciclovir Prophylaxis Versus Preemptive Therapy in Cytomegalovirus-Positive Renal Allograft Recipients: Long-term Results After 7 Years of a Randomized Clinical Trial. Transplantation. 2018 May;102(5):876-882. doi: 10.1097/TP.0000000000002024.
Results Reference
derived
Learn more about this trial
A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation
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