Cytomegalovirus Infections
Conditions
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.
Interventions
900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
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.
DRUGGanciclovir
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.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Active Cytomegalovirus (CMV) Infection Within 12 Months | Up to 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 | Up to 12 months | 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 | Up to 12 months | 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 | Up to 84 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Creatinine Clearance at Month 12 | Up to 12 months | 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 | Up to 12 months | — |
| Days of Hospitalization | Up to 12 months | — |
| Relationship Between Proteomics Pattern and Graft Survival | Up to 12 months | 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 | Up to 12 months | 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 | Up to 12 months | 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 | Up to 12 months | 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 | Up to 12 months | 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 | Up to 12 months | — |
| Percentage of Participants With Graft Survival at Month 12 | Up to 12 months | — |
| Percentage of Participants With Leukopenia Within 12 Months | Up to 12 months | Leukopenia: white blood cell (WBC) of \< 3,500/microlitre (μL) and \< 1,000/μL |
| Percentage of Participants With Neutropenia Within 12 Months | Up to 12 months | Neutropenia: absolute neutrophil count (ANC) \< 750/μL within 12 months. |
| Percentage of Participants With Any Opportunistic Infection Within 12 Months | Up to 12 months | — |
| Percentage of Participants With Post-Transplant Diabetes Mellitus | Up to 12 months | — |
| Percentage of Participants With Active CMV Infections Not Responding to Valganciclovir or IV Ganciclovir Treatment | Up to 12 months | 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 | From Month 24 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 | From Month 24 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 | From Month 24 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 | From Month 24 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 | From Month 24 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 | From Month 24 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 | From Month 24 to Month 84 | — |
| Number of Participants Who Died From Months 24 to Month 84 | From Month 24 to Month 84 | — |
| Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84 | From Month 24 to Month 84 | — |
| Number of Participants Who Had Lost Their Transplant up to Month 84 | From Month 24 to Month 84 | — |
| Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84 | From Month 24 to Month 84 | — |
| Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84 | From Month 24 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 | Up to 84 months | 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 | Up to 84 months | 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 | From Month 24 to Month 84 | — |
| Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84 | From Month 24 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 | From Month 24 to Month 84 | — |
| Percentage of Participants With CMV Syndrome Within 12 Months | Up to 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). |
| Creatinine Clearance at Month 24 and Every 12 Months up to Month 84 | From Month 24 to Month 84 | Creatinine Clearance estimated by Cockcroft-Gault formula. |
| Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | From Month 24 to Month 84 | — |
| Percentage of Participants With CMV Tissue Invasive Disease Within 12 Months | Up to 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 | Up to 12 months | Viremia was defined as plasma PCR ≥ 400 copies/ml. |
| Viral Burden at Viremia | Up to 12 months | Time-weighted area under the curve (AUC) of the polymerase chain reaction (PCR). Viremia was defined as plasma PCR ≥ 400 copies/ml. |
Countries
Austria, Germany
Participant flow
Pre-assignment details
342 participants were screened, and 43 participants were not randomized. Central randomization stratified by study center and by induction immunosuppression with polyclonal antibodies, such as such as antithymocyte globuline (ATG), anti-lymphocyte globulin (ALG), or Muromonab-CD3 was performed.
Participants by arm
| Arm | Count |
|---|---|
| Valganciclovir CMV Prophylaxis Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation. | 148 |
| Pre-emptive CMV Therapy Valganciclovir (Pre-emptive CMV Therapy): 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.
Ganciclovir: 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. | 151 |
| Total | 299 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow-Up Phase | Administrative | 1 | 0 |
| Follow-Up Phase | Adverse event/intercurrent illness | 1 | 0 |
| Follow-Up Phase | Consent withdrawn | 13 | 19 |
| Follow-Up Phase | Death | 9 | 12 |
| Follow-Up Phase | Graft loss | 8 | 7 |
| Follow-Up Phase | Lost to Follow-up | 12 | 10 |
| Follow-Up Phase | Reason not specified | 2 | 3 |
| Follow-Up Phase | Refused treatment/did not cooperate | 0 | 1 |
| Study Phase | Consent withdrawn | 16 | 14 |
| Study Phase | Death | 3 | 2 |
| Study Phase | Graft loss | 0 | 3 |
| Study Phase | Lost to Follow-up | 3 | 3 |
| Study Phase | Protocol Violation | 3 | 4 |
| Study Phase | Reason not specified | 3 | 2 |
| Study Phase | Refused treatment/did not cooperate | 3 | 1 |
Baseline characteristics
| Characteristic | Valganciclovir CMV Prophylaxis | Pre-emptive CMV Therapy | Total |
|---|---|---|---|
| Age, Continuous | 51.18 years STANDARD_DEVIATION 13.463 | 54.24 years STANDARD_DEVIATION 11.906 | 52.73 years STANDARD_DEVIATION 12.771 |
| Sex: Female, Male Female | 45 Participants | 55 Participants | 100 Participants |
| Sex: Female, Male Male | 103 Participants | 96 Participants | 199 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 139 / 148 | 140 / 151 |
| serious Total, serious adverse events | 94 / 148 | 96 / 151 |
Outcome results
Primary
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).
Time frame: Up to 12 months
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valganciclovir CMV Prophylaxis | Percentage of Participants With Active Cytomegalovirus (CMV) Infection Within 12 Months | 14.1 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With Active Cytomegalovirus (CMV) Infection Within 12 Months | 42.6 percentage of participants |
96% CI: [-39.7, -17.3]
Primary
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.
Time frame: Up to 12 months
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valganciclovir CMV Prophylaxis | Percentage of Participants With CMV Disease Within 12 Months Including CMV Syndrome and Tissue Invasive Disease | 5.6 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With CMV Disease Within 12 Months Including CMV Syndrome and Tissue Invasive Disease | 16.9 percentage of participants |
96% CI: [-19.2, -3.4]
Primary
Percentage of Participants With Graft Loss at Month 84
Time frame: Up to 84 months
Population: The intent-to-treat (ITT) population included all randomized participants. Descriptive analysis only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valganciclovir CMV Prophylaxis | Percentage of Participants With Graft Loss at Month 84 | 7.43 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With Graft Loss at Month 84 | 8.61 percentage of participants |
Primary
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.
Time frame: Up to 12 months
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Urine Proteomic Pattern at Month 12 | -0.1057 units on a scale | Standard Error 0.1538 |
| Pre-emptive CMV Therapy | Urine Proteomic Pattern at Month 12 | 0.1452 units on a scale | Standard Error 0.1006 |
p-value: 0.173999% CI: [-0.2271, 0.7289]F-test
Secondary
Creatinine Clearance at Month 12
Creatinine clearance was estimated using the Cockcroft-Gault formula.
Time frame: Up to 12 months
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Creatinine Clearance at Month 12 | 61.1 millilitre(s)/minute | Standard Deviation 23.3 |
| Pre-emptive CMV Therapy | Creatinine Clearance at Month 12 | 61.3 millilitre(s)/minute | Standard Deviation 22.24 |
Secondary
Creatinine Clearance at Month 24 and Every 12 Months up to Month 84
Creatinine Clearance estimated by Cockcroft-Gault formula.
Time frame: From Month 24 to Month 84
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Creatinine Clearance at Month 24 and Every 12 Months up to Month 84 | 24 months | 63.2 millimiters/minute | Standard Deviation 23.85 |
| Valganciclovir CMV Prophylaxis | Creatinine Clearance at Month 24 and Every 12 Months up to Month 84 | 36 months | 63.9 millimiters/minute | Standard Deviation 24.14 |
| Valganciclovir CMV Prophylaxis | Creatinine Clearance at Month 24 and Every 12 Months up to Month 84 | 48 months | 63.1 millimiters/minute | Standard Deviation 23.81 |
| Valganciclovir CMV Prophylaxis | Creatinine Clearance at Month 24 and Every 12 Months up to Month 84 | 60 months | 62.2 millimiters/minute | Standard Deviation 22.58 |
| Valganciclovir CMV Prophylaxis | Creatinine Clearance at Month 24 and Every 12 Months up to Month 84 | 72 months | 63.3 millimiters/minute | Standard Deviation 28.98 |
| Valganciclovir CMV Prophylaxis | Creatinine Clearance at Month 24 and Every 12 Months up to Month 84 | 84 months | 59.5 millimiters/minute | Standard Deviation 26.76 |
| Pre-emptive CMV Therapy | Creatinine Clearance at Month 24 and Every 12 Months up to Month 84 | 48 months | 62.6 millimiters/minute | Standard Deviation 24.63 |
| Pre-emptive CMV Therapy | Creatinine Clearance at Month 24 and Every 12 Months up to Month 84 | 24 months | 62.9 millimiters/minute | Standard Deviation 25.01 |
| Pre-emptive CMV Therapy | Creatinine Clearance at Month 24 and Every 12 Months up to Month 84 | 72 months | 64.7 millimiters/minute | Standard Deviation 27.25 |
| Pre-emptive CMV Therapy | Creatinine Clearance at Month 24 and Every 12 Months up to Month 84 | 84 months | 60.8 millimiters/minute | Standard Deviation 25.39 |
| Pre-emptive CMV Therapy | Creatinine Clearance at Month 24 and Every 12 Months up to Month 84 | 36 months | 64.5 millimiters/minute | Standard Deviation 25.33 |
| Pre-emptive CMV Therapy | Creatinine Clearance at Month 24 and Every 12 Months up to Month 84 | 60 months | 64.9 millimiters/minute | Standard Deviation 27.85 |
Secondary
Days of Hospitalization
Time frame: Up to 12 months
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Valganciclovir CMV Prophylaxis | Days of Hospitalization | 26.5 days |
| Pre-emptive CMV Therapy | Days of Hospitalization | 32 days |
Secondary
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).
Time frame: Up to 84 months
Population: The intent-to-treat (ITT) population included all randomized participants. Only participants in the Pre-emptive CMV Therapy arm (separated based on their active CMV infection status at Month 84) were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valganciclovir CMV Prophylaxis | 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 | 17.9 percentage of participants |
| Pre-emptive CMV Therapy | 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 | 5.8 percentage of participants |
95% CI: [-0.1, 24.2]
Secondary
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).
Time frame: Up to 84 months
Population: The intent-to-treat (ITT) population included all randomized participants. Only participants in the Valganciclovir CMV Prophylaxis arm (separated based on their active CMV infection status at Month 84) were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valganciclovir CMV Prophylaxis | 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 | 8.3 percentage of participants |
| Pre-emptive CMV Therapy | 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 | 11.5 percentage of participants |
95% CI: [-20.2, 13.9]
Secondary
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
Population: The intent-to-treat (ITT) population included all randomized participants. The number analyzed in the table indicates the number of participants with at least one rejection episode at each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 48 months: CMV Negative Donor | 21 graft rejections |
| Valganciclovir CMV Prophylaxis | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 24 months: CMV Positive Donor | 39 graft rejections |
| Valganciclovir CMV Prophylaxis | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 60 months: CMV Positive Donor | 46 graft rejections |
| Valganciclovir CMV Prophylaxis | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 48 months: CMV Positive Donor | 45 graft rejections |
| Valganciclovir CMV Prophylaxis | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 60 months: CMV Negative Donor | 21 graft rejections |
| Valganciclovir CMV Prophylaxis | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 24 months: CMV Negative Donor | 20 graft rejections |
| Valganciclovir CMV Prophylaxis | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 72 months: CMV Positive Donor | 48 graft rejections |
| Valganciclovir CMV Prophylaxis | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 36 months: CMV Negative Donor | 20 graft rejections |
| Valganciclovir CMV Prophylaxis | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 72 months: CMV Negative Donor | 21 graft rejections |
| Valganciclovir CMV Prophylaxis | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 36 months: CMV Positive Donor | 42 graft rejections |
| Valganciclovir CMV Prophylaxis | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 84 months: CMV Negative Donor | 21 graft rejections |
| Valganciclovir CMV Prophylaxis | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 84 months: CMV Positive Donor | 48 graft rejections |
| Pre-emptive CMV Therapy | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 84 months: CMV Negative Donor | 31 graft rejections |
| Pre-emptive CMV Therapy | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 36 months: CMV Negative Donor | 28 graft rejections |
| Pre-emptive CMV Therapy | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 72 months: CMV Negative Donor | 29 graft rejections |
| Pre-emptive CMV Therapy | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 24 months: CMV Positive Donor | 48 graft rejections |
| Pre-emptive CMV Therapy | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 24 months: CMV Negative Donor | 27 graft rejections |
| Pre-emptive CMV Therapy | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 48 months: CMV Positive Donor | 51 graft rejections |
| Pre-emptive CMV Therapy | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 48 months: CMV Negative Donor | 28 graft rejections |
| Pre-emptive CMV Therapy | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 60 months: CMV Positive Donor | 52 graft rejections |
| Pre-emptive CMV Therapy | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 60 months: CMV Negative Donor | 29 graft rejections |
| Pre-emptive CMV Therapy | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 72 months: CMV Positive Donor | 53 graft rejections |
| Pre-emptive CMV Therapy | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 84 months: CMV Positive Donor | 53 graft rejections |
| Pre-emptive CMV Therapy | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 36 months: CMV Positive Donor | 51 graft rejections |
Secondary
Number of Participants Who Died From Months 24 to Month 84
Time frame: From Month 24 to Month 84
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Number of Participants Who Died From Months 24 to Month 84 | 48 months | 8 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants Who Died From Months 24 to Month 84 | 24 months | 3 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants Who Died From Months 24 to Month 84 | 36 months | 6 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants Who Died From Months 24 to Month 84 | 60 months | 11 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants Who Died From Months 24 to Month 84 | 72 months | 14 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants Who Died From Months 24 to Month 84 | 84 months | 14 Participants |
| Pre-emptive CMV Therapy | Number of Participants Who Died From Months 24 to Month 84 | 72 months | 16 Participants |
| Pre-emptive CMV Therapy | Number of Participants Who Died From Months 24 to Month 84 | 60 months | 12 Participants |
| Pre-emptive CMV Therapy | Number of Participants Who Died From Months 24 to Month 84 | 24 months | 8 Participants |
| Pre-emptive CMV Therapy | Number of Participants Who Died From Months 24 to Month 84 | 84 months | 17 Participants |
| Pre-emptive CMV Therapy | Number of Participants Who Died From Months 24 to Month 84 | 36 months | 9 Participants |
| Pre-emptive CMV Therapy | Number of Participants Who Died From Months 24 to Month 84 | 48 months | 10 Participants |
Secondary
Number of Participants Who Had Lost Their Transplant or Died up to Month 84
Time frame: From Month 24 to Month 84
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Number of Participants Who Had Lost Their Transplant or Died up to Month 84 | 24 months | 7 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants Who Had Lost Their Transplant or Died up to Month 84 | 36 months | 9 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants Who Had Lost Their Transplant or Died up to Month 84 | 48 months | 12 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants Who Had Lost Their Transplant or Died up to Month 84 | 60 months | 16 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants Who Had Lost Their Transplant or Died up to Month 84 | 72 months | 21 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants Who Had Lost Their Transplant or Died up to Month 84 | 84 months | 24 Participants |
| Pre-emptive CMV Therapy | Number of Participants Who Had Lost Their Transplant or Died up to Month 84 | 72 months | 28 Participants |
| Pre-emptive CMV Therapy | Number of Participants Who Had Lost Their Transplant or Died up to Month 84 | 24 months | 15 Participants |
| Pre-emptive CMV Therapy | Number of Participants Who Had Lost Their Transplant or Died up to Month 84 | 60 months | 23 Participants |
| Pre-emptive CMV Therapy | Number of Participants Who Had Lost Their Transplant or Died up to Month 84 | 36 months | 18 Participants |
| Pre-emptive CMV Therapy | Number of Participants Who Had Lost Their Transplant or Died up to Month 84 | 84 months | 29 Participants |
| Pre-emptive CMV Therapy | Number of Participants Who Had Lost Their Transplant or Died up to Month 84 | 48 months | 19 Participants |
Secondary
Number of Participants Who Had Lost Their Transplant up to Month 84
Time frame: From Month 24 to Month 84
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Number of Participants Who Had Lost Their Transplant up to Month 84 | 72 months | 8 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants Who Had Lost Their Transplant up to Month 84 | 60 months | 6 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants Who Had Lost Their Transplant up to Month 84 | 36 months | 4 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants Who Had Lost Their Transplant up to Month 84 | 84 months | 11 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants Who Had Lost Their Transplant up to Month 84 | 48 months | 5 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants Who Had Lost Their Transplant up to Month 84 | 24 months | 4 Participants |
| Pre-emptive CMV Therapy | Number of Participants Who Had Lost Their Transplant up to Month 84 | 48 months | 10 Participants |
| Pre-emptive CMV Therapy | Number of Participants Who Had Lost Their Transplant up to Month 84 | 60 months | 12 Participants |
| Pre-emptive CMV Therapy | Number of Participants Who Had Lost Their Transplant up to Month 84 | 72 months | 13 Participants |
| Pre-emptive CMV Therapy | Number of Participants Who Had Lost Their Transplant up to Month 84 | 84 months | 13 Participants |
| Pre-emptive CMV Therapy | Number of Participants Who Had Lost Their Transplant up to Month 84 | 24 months | 8 Participants |
| Pre-emptive CMV Therapy | Number of Participants Who Had Lost Their Transplant up to Month 84 | 36 months | 10 Participants |
Secondary
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).
Time frame: From Month 24 to Month 84
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84 | 24 months | 16 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84 | 36 months | 16 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84 | 48 months | 16 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84 | 60 months | 16 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84 | 72 months | 17 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84 | 84 months | 17 Participants |
| Pre-emptive CMV Therapy | Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84 | 72 months | 60 Participants |
| Pre-emptive CMV Therapy | Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84 | 24 months | 59 Participants |
| Pre-emptive CMV Therapy | Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84 | 60 months | 59 Participants |
| Pre-emptive CMV Therapy | Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84 | 36 months | 59 Participants |
| Pre-emptive CMV Therapy | Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84 | 84 months | 60 Participants |
| Pre-emptive CMV Therapy | Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84 | 48 months | 59 Participants |
Secondary
Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84
Time frame: From Month 24 to Month 84
Population: The intent-to-treat (ITT) population included all randomized participants. Only participants with active CMV infection were included in this analysis; 1 participant in each treatment arm had not developed active CMV infection until Month 72, and thus, they were only included in the number analyzed for results starting from that timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 24 months | 0 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 36 months | 0 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 48 months | 0 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 60 months | 0 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 72 months | 0 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 84 months | 1 Participants |
| Pre-emptive CMV Therapy | Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 72 months | 9 Participants |
| Pre-emptive CMV Therapy | Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 24 months | 5 Participants |
| Pre-emptive CMV Therapy | Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 60 months | 9 Participants |
| Pre-emptive CMV Therapy | Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 36 months | 7 Participants |
| Pre-emptive CMV Therapy | Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 84 months | 9 Participants |
| Pre-emptive CMV Therapy | Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 48 months | 7 Participants |
Secondary
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.
Time frame: From Month 24 to Month 84
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84 | 36 months | 7 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84 | 24 months | 7 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84 | 72 months | 7 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84 | 48 months | 7 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84 | 84 months | 7 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84 | 60 months | 7 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84 | 84 months | 24 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84 | 24 months | 23 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84 | 36 months | 23 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84 | 48 months | 23 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84 | 60 months | 24 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84 | 72 months | 24 Participants |
Secondary
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.
Time frame: From Month 24 to Month 84
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 24 months | 7 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 36 months | 7 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 48 months | 7 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 60 months | 7 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 72 months | 7 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 84 months | 7 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 72 months | 24 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 24 months | 23 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 60 months | 24 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 36 months | 23 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 84 months | 24 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 48 months | 23 Participants |
Secondary
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).
Time frame: From Month 24 to Month 84
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84 | 24 months | 7 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84 | 36 months | 7 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84 | 48 months | 7 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84 | 60 months | 7 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84 | 72 months | 7 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84 | 84 months | 7 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84 | 72 months | 21 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84 | 24 months | 20 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84 | 60 months | 21 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84 | 36 months | 20 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84 | 84 months | 21 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84 | 48 months | 20 Participants |
Secondary
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.
Time frame: From Month 24 to Month 84
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 24 months | 4 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 36 months | 4 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 48 months | 4 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 60 months | 4 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 72 months | 4 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 84 months | 4 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 72 months | 5 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 24 months | 5 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 60 months | 5 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 36 months | 5 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 84 months | 5 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 48 months | 5 Participants |
Secondary
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.
Time frame: From Month 24 to Month 84
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84 | 72 months | 17 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84 | 36 months | 16 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84 | 84 months | 17 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84 | 48 months | 16 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84 | 24 months | 16 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84 | 60 months | 16 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84 | 84 months | 60 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84 | 60 months | 59 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84 | 72 months | 60 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84 | 24 months | 59 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84 | 36 months | 59 Participants |
| Pre-emptive CMV Therapy | Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84 | 48 months | 59 Participants |
Secondary
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
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Valganciclovir CMV Prophylaxis | 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 | 36 months: CMV Positive Donor | No Rejections | 64 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 36 months: CMV Negative Donor | At Least One Rejection | 15 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 24 months: CMV Positive Donor | At Least One Rejection | 26 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 24 months: CMV Positive Donor | No Rejections | 65 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 24 months: CMV Negative Donor | At Least One Rejection | 15 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 24 months: CMV Negative Donor | No Rejections | 42 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 36 months: CMV Positive Donor | At Least One Rejection | 27 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 36 months: CMV Negative Donor | No Rejections | 42 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 48 months: CMV Positive Donor | At Least One Rejection | 27 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 48 months: CMV Positive Donor | No Rejections | 64 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 48 months: CMV Negative Donor | At Least One Rejection | 15 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 48 months: CMV Negative Donor | No Rejections | 42 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 60 months: CMV Positive Donor | At Least One Rejection | 27 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 60 months: CMV Positive Donor | No Rejections | 64 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 60 months: CMV Negative Donor | At Least One Rejection | 15 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 60 months: CMV Negative Donor | No Rejections | 42 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 72 months: CMV Positive Donor | At Least One Rejection | 28 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 72 months: CMV Positive Donor | No Rejections | 63 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 72 months: CMV Negative Donor | At Least One Rejection | 15 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 72 months: CMV Negative Donor | No Rejections | 42 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 84 months: CMV Positive Donor | At Least One Rejection | 28 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 84 months: CMV Positive Donor | No Rejections | 63 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 84 months: CMV Negative Donor | At Least One Rejection | 15 Participants |
| Valganciclovir CMV Prophylaxis | 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 | 84 months: CMV Negative Donor | No Rejections | 42 Participants |
| Pre-emptive CMV Therapy | 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 | 84 months: CMV Negative Donor | At Least One Rejection | 15 Participants |
| Pre-emptive CMV Therapy | 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 | 60 months: CMV Positive Donor | At Least One Rejection | 28 Participants |
| Pre-emptive CMV Therapy | 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 | 72 months: CMV Negative Donor | At Least One Rejection | 15 Participants |
| Pre-emptive CMV Therapy | 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 | 24 months: CMV Positive Donor | At Least One Rejection | 27 Participants |
| Pre-emptive CMV Therapy | 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 | 60 months: CMV Positive Donor | No Rejections | 51 Participants |
| Pre-emptive CMV Therapy | 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 | 24 months: CMV Positive Donor | No Rejections | 52 Participants |
| Pre-emptive CMV Therapy | 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 | 84 months: CMV Positive Donor | No Rejections | 51 Participants |
| Pre-emptive CMV Therapy | 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 | 24 months: CMV Negative Donor | At Least One Rejection | 13 Participants |
| Pre-emptive CMV Therapy | 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 | 60 months: CMV Negative Donor | At Least One Rejection | 15 Participants |
| Pre-emptive CMV Therapy | 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 | 24 months: CMV Negative Donor | No Rejections | 59 Participants |
| Pre-emptive CMV Therapy | 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 | 72 months: CMV Negative Donor | No Rejections | 57 Participants |
| Pre-emptive CMV Therapy | 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 | 36 months: CMV Positive Donor | At Least One Rejection | 27 Participants |
| Pre-emptive CMV Therapy | 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 | 36 months: CMV Positive Donor | No Rejections | 52 Participants |
| Pre-emptive CMV Therapy | 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 | 36 months: CMV Negative Donor | At Least One Rejection | 14 Participants |
| Pre-emptive CMV Therapy | 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 | 60 months: CMV Negative Donor | No Rejections | 57 Participants |
| Pre-emptive CMV Therapy | 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 | 36 months: CMV Negative Donor | No Rejections | 58 Participants |
| Pre-emptive CMV Therapy | 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 | 84 months: CMV Negative Donor | No Rejections | 57 Participants |
| Pre-emptive CMV Therapy | 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 | 48 months: CMV Positive Donor | At Least One Rejection | 27 Participants |
| Pre-emptive CMV Therapy | 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 | 72 months: CMV Positive Donor | At Least One Rejection | 28 Participants |
| Pre-emptive CMV Therapy | 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 | 48 months: CMV Positive Donor | No Rejections | 52 Participants |
| Pre-emptive CMV Therapy | 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 | 84 months: CMV Positive Donor | At Least One Rejection | 28 Participants |
| Pre-emptive CMV Therapy | 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 | 48 months: CMV Negative Donor | At Least One Rejection | 14 Participants |
| Pre-emptive CMV Therapy | 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 | 72 months: CMV Positive Donor | No Rejections | 51 Participants |
| Pre-emptive CMV Therapy | 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 | 48 months: CMV Negative Donor | No Rejections | 58 Participants |
Secondary
Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84
Time frame: From Month 24 to Month 84
Population: The intent-to-treat (ITT) population included all randomized participants. Only participants without active CMV infection were included in this analysis; 1 participant in each treatment arm had not developed active CMV infection until Month 72, and thus, they were only included in the number analyzed for results before that timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 24 months | 4 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 36 months | 4 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 48 months | 5 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 60 months | 6 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 72 months | 8 Participants |
| Valganciclovir CMV Prophylaxis | Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 84 months | 10 Participants |
| Pre-emptive CMV Therapy | Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 72 months | 4 Participants |
| Pre-emptive CMV Therapy | Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 24 months | 3 Participants |
| Pre-emptive CMV Therapy | Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 60 months | 3 Participants |
| Pre-emptive CMV Therapy | Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 36 months | 3 Participants |
| Pre-emptive CMV Therapy | Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 84 months | 4 Participants |
| Pre-emptive CMV Therapy | Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 48 months | 3 Participants |
Secondary
Percentage of Participants Surviving at Month 12
Time frame: Up to 12 months
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valganciclovir CMV Prophylaxis | Percentage of Participants Surviving at Month 12 | 98 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants Surviving at Month 12 | 98.7 percentage of participants |
Secondary
Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84
Time frame: From Month 24 to Month 84
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84 | 24 months | 97.97 percentage of participants |
| Valganciclovir CMV Prophylaxis | Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84 | 36 months | 95.95 percentage of participants |
| Valganciclovir CMV Prophylaxis | Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84 | 48 months | 94.59 percentage of participants |
| Valganciclovir CMV Prophylaxis | Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84 | 60 months | 92.57 percentage of participants |
| Valganciclovir CMV Prophylaxis | Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84 | 72 months | 90.54 percentage of participants |
| Valganciclovir CMV Prophylaxis | Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84 | 84 months | 90.54 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84 | 72 months | 89.40 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84 | 24 months | 94.70 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84 | 60 months | 92.05 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84 | 36 months | 94.04 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84 | 84 months | 88.74 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84 | 48 months | 93.38 percentage of participants |
Secondary
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).
Time frame: Up to 12 months
Population: The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valganciclovir CMV Prophylaxis | Percentage of Participants With Active CMV Infections Not Responding to Valganciclovir or IV Ganciclovir Treatment | 11.8 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With Active CMV Infections Not Responding to Valganciclovir or IV Ganciclovir Treatment | 18.3 percentage of participants |
Secondary
Percentage of Participants With Any Opportunistic Infection Within 12 Months
Time frame: Up to 12 months
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valganciclovir CMV Prophylaxis | Percentage of Participants With Any Opportunistic Infection Within 12 Months | 31.1 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With Any Opportunistic Infection Within 12 Months | 37.7 percentage of participants |
Secondary
Percentage of Participants With at Least One Treated and Biopsy-Proven Acute Rejection Episode Within 12 Months
Time frame: Up to 12 months
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valganciclovir CMV Prophylaxis | Percentage of Participants With at Least One Treated and Biopsy-Proven Acute Rejection Episode Within 12 Months | 18.2 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With at Least One Treated and Biopsy-Proven Acute Rejection Episode Within 12 Months | 13.2 percentage of participants |
Secondary
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).
Time frame: Up to 12 months
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valganciclovir CMV Prophylaxis | Percentage of Participants With CMV Syndrome Within 12 Months | 5.6 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With CMV Syndrome Within 12 Months | 14.6 percentage of participants |
Secondary
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 frame: Up to 12 months
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valganciclovir CMV Prophylaxis | Percentage of Participants With CMV Tissue Invasive Disease Within 12 Months | 3.3 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With CMV Tissue Invasive Disease Within 12 Months | 3.6 percentage of participants |
Secondary
Percentage of Participants With Graft Survival at Month 12
Time frame: Up to 12 months
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valganciclovir CMV Prophylaxis | Percentage of Participants With Graft Survival at Month 12 | 98.6 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With Graft Survival at Month 12 | 96.0 percentage of participants |
Secondary
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
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84 | 24 months | 97.30 percentage of participants |
| Valganciclovir CMV Prophylaxis | Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84 | 48 months | 96.62 percentage of participants |
| Valganciclovir CMV Prophylaxis | Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84 | 72 months | 94.59 percentage of participants |
| Valganciclovir CMV Prophylaxis | Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84 | 60 months | 95.95 percentage of participants |
| Valganciclovir CMV Prophylaxis | Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84 | 84 months | 92.57 percentage of participants |
| Valganciclovir CMV Prophylaxis | Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84 | 36 months | 97.30 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84 | 84 months | 91.39 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84 | 60 months | 92.05 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84 | 24 months | 94.70 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84 | 36 months | 93.38 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84 | 72 months | 91.39 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84 | 48 months | 93.38 percentage of participants |
Secondary
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
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84 | 24 months | 95.27 percentage of participants |
| Valganciclovir CMV Prophylaxis | Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84 | 48 months | 91.89 percentage of participants |
| Valganciclovir CMV Prophylaxis | Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84 | 72 months | 85.81 percentage of participants |
| Valganciclovir CMV Prophylaxis | Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84 | 60 months | 89.19 percentage of participants |
| Valganciclovir CMV Prophylaxis | Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84 | 84 months | 83.78 percentage of participants |
| Valganciclovir CMV Prophylaxis | Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84 | 36 months | 93.92 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84 | 84 months | 80.79 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84 | 60 months | 84.77 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84 | 24 months | 90.07 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84 | 36 months | 88.08 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84 | 72 months | 81.46 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84 | 48 months | 87.42 percentage of participants |
Secondary
Percentage of Participants With Leukopenia Within 12 Months
Leukopenia: white blood cell (WBC) of \< 3,500/microlitre (μL) and \< 1,000/μL
Time frame: Up to 12 months
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valganciclovir CMV Prophylaxis | Percentage of Participants With Leukopenia Within 12 Months | 35.1 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With Leukopenia Within 12 Months | 26.5 percentage of participants |
Secondary
Percentage of Participants With Neutropenia Within 12 Months
Neutropenia: absolute neutrophil count (ANC) \< 750/μL within 12 months.
Time frame: Up to 12 months
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valganciclovir CMV Prophylaxis | Percentage of Participants With Neutropenia Within 12 Months | 16.9 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With Neutropenia Within 12 Months | 12.6 percentage of participants |
Secondary
Percentage of Participants With Post-Transplant Diabetes Mellitus
Time frame: Up to 12 months
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Percentage of Participants With Post-Transplant Diabetes Mellitus | Month 6 | 2.7 percentage of participants |
| Valganciclovir CMV Prophylaxis | Percentage of Participants With Post-Transplant Diabetes Mellitus | Month 12 | 3.4 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With Post-Transplant Diabetes Mellitus | Month 6 | 1.3 percentage of participants |
| Pre-emptive CMV Therapy | Percentage of Participants With Post-Transplant Diabetes Mellitus | Month 12 | 0.7 percentage of participants |
Secondary
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.
Time frame: Up to 12 months
Population: The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Proteomics Parameter: CKD273 | Visit 6 (n=113, 114) | 0.372 score on a scale | Standard Deviation 0.3562 |
| Valganciclovir CMV Prophylaxis | Proteomics Parameter: CKD273 | Visit 13 (n=102, 110) | 0.258 score on a scale | Standard Deviation 0.3719 |
| Valganciclovir CMV Prophylaxis | Proteomics Parameter: CKD273 | Visit 15 (n=106, 102) | 0.276 score on a scale | Standard Deviation 0.3824 |
| Pre-emptive CMV Therapy | Proteomics Parameter: CKD273 | Visit 15 (n=106, 102) | 0.326 score on a scale | Standard Deviation 0.3618 |
| Pre-emptive CMV Therapy | Proteomics Parameter: CKD273 | Visit 6 (n=113, 114) | 0.394 score on a scale | Standard Deviation 0.3556 |
| Pre-emptive CMV Therapy | Proteomics Parameter: CKD273 | Visit 13 (n=102, 110) | 0.295 score on a scale | Standard Deviation 0.3637 |
Secondary
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.
Time frame: Up to 12 months
Population: The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Proteomics Parameter: CMV | Visit 6 (n=113, 114) | -0.004 score on a scale | Standard Deviation 0.9504 |
| Valganciclovir CMV Prophylaxis | Proteomics Parameter: CMV | Visit 13 (n=102, 110) | 0.036 score on a scale | Standard Deviation 0.7976 |
| Valganciclovir CMV Prophylaxis | Proteomics Parameter: CMV | Visit 15 (n=106, 102) | -0.073 score on a scale | Standard Deviation 0.6894 |
| Pre-emptive CMV Therapy | Proteomics Parameter: CMV | Visit 6 (n=113, 114) | -0.018 score on a scale | Standard Deviation 0.8927 |
| Pre-emptive CMV Therapy | Proteomics Parameter: CMV | Visit 13 (n=102, 110) | -0.05 score on a scale | Standard Deviation 0.7583 |
| Pre-emptive CMV Therapy | Proteomics Parameter: CMV | Visit 15 (n=106, 102) | -0.068 score on a scale | Standard Deviation 0.7081 |
Secondary
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.
Time frame: Up to 12 months
Population: The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Proteomics Parameter: Nephropathy | Visit 6 (n=113, 114) | 0.102 score on a scale | Standard Deviation 1.1745 |
| Valganciclovir CMV Prophylaxis | Proteomics Parameter: Nephropathy | Visit 13 (n=102, 110) | -0.05 score on a scale | Standard Deviation 1.0624 |
| Valganciclovir CMV Prophylaxis | Proteomics Parameter: Nephropathy | Visit 15 (n=106, 102) | 0.019 score on a scale | Standard Deviation 0.9105 |
| Pre-emptive CMV Therapy | Proteomics Parameter: Nephropathy | Visit 6 (n=113, 114) | 0.122 score on a scale | Standard Deviation 1.0595 |
| Pre-emptive CMV Therapy | Proteomics Parameter: Nephropathy | Visit 13 (n=102, 110) | 0.001 score on a scale | Standard Deviation 1.0826 |
| Pre-emptive CMV Therapy | Proteomics Parameter: Nephropathy | Visit 15 (n=106, 102) | 0.102 score on a scale | Standard Deviation 1.1221 |
Secondary
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.
Time frame: Up to 12 months
Population: The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Graft Survival | CMV:Visit 6: Without Graft Loss (n=112, 110) | 0.000 score on a scale | Standard Deviation 0.9535 |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Graft Survival | CKD273:Visit 6: Without Graft Loss (n=112, 110) | 0.371 score on a scale | Standard Deviation 0.3578 |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Graft Survival | Nephropathy:Visit 15: With Graft Loss (n=2, 0) | 1.350 score on a scale | Standard Deviation 2.8991 |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Graft Survival | CMV:Visit 13: Without Graft Loss (n=102, 109) | 0.036 score on a scale | Standard Deviation 0.7976 |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Graft Survival | CMV:Visit 15: With Graft Loss (n=2, 0) | 0.100 score on a scale | Standard Deviation 0.7071 |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Graft Survival | CMV:Visit 15: Without Graft Loss (n=104, 102) | -0.076 score on a scale | Standard Deviation 0.6922 |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Graft Survival | Nephropathy:Visit15: Without Graft Loss(n=104,102) | -0.007 score on a scale | Standard Deviation 0.8535 |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Graft Survival | Nephropathy:Visit 6: With Graft Loss (n=1, 4) | -0.500 score on a scale | — |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Graft Survival | CKD273:Visit 15: With Graft Loss (n=2, 0) | 0.600 score on a scale | Standard Deviation 0.5657 |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Graft Survival | Nephropathy:Visit 6:Without Graft Loss (n=112,110) | 0.107 score on a scale | Standard Deviation 1.1784 |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Graft Survival | CKD273:Visit 15: Without Graft Loss (n=104, 102) | 0.270 score on a scale | Standard Deviation 0.3793 |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Graft Survival | CKD273:Visit 6: With Graft Loss (n=1, 4) | 0.400 score on a scale | — |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Graft Survival | Nephropathy:Visit 13:Without Graft Loss(n=102,109) | -0.050 score on a scale | Standard Deviation 1.0624 |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Graft Survival | CMV:Visit 6: With Graft Loss (n=1, 4) | -0.500 score on a scale | — |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Graft Survival | CKD273:Visit 13: Without Graft Loss (n=102, 109) | 0.258 score on a scale | Standard Deviation 0.3719 |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Graft Survival | Nephropathy:Visit15: Without Graft Loss(n=104,102) | 0.102 score on a scale | Standard Deviation 1.1221 |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Graft Survival | CMV:Visit 13: Without Graft Loss (n=102, 109) | -0.048 score on a scale | Standard Deviation 0.7614 |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Graft Survival | CKD273:Visit 6: With Graft Loss (n=1, 4) | 0.800 score on a scale | Standard Deviation 0.2944 |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Graft Survival | CKD273:Visit 6: Without Graft Loss (n=112, 110) | 0.379 score on a scale | Standard Deviation 0.3499 |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Graft Survival | CKD273:Visit 13: Without Graft Loss (n=102, 109) | 0.293 score on a scale | Standard Deviation 0.3648 |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Graft Survival | CKD273:Visit 15: Without Graft Loss (n=104, 102) | 0.326 score on a scale | Standard Deviation 0.3618 |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Graft Survival | CMV:Visit 6: With Graft Loss (n=1, 4) | -0.300 score on a scale | Standard Deviation 0.7616 |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Graft Survival | CMV:Visit 6: Without Graft Loss (n=112, 110) | -0.007 score on a scale | Standard Deviation 0.8984 |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Graft Survival | CMV:Visit 13: With Graft Loss (n=0, 1) | -0.300 score on a scale | — |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Graft Survival | CMV:Visit 15: Without Graft Loss (n=104, 102) | -0.068 score on a scale | Standard Deviation 0.7081 |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Graft Survival | Nephropathy:Visit 6: With Graft Loss (n=1, 4) | 1.100 score on a scale | Standard Deviation 0.9933 |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Graft Survival | Nephropathy:Visit 6:Without Graft Loss (n=112,110) | 0.086 score on a scale | Standard Deviation 1.0489 |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Graft Survival | Nephropathy:Visit 13: With Graft Loss (n=0, 1) | -0.800 score on a scale | — |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Graft Survival | Nephropathy:Visit 13:Without Graft Loss(n=102,109) | 0.008 score on a scale | Standard Deviation 1.0848 |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Graft Survival | CKD273:Visit 13: With Graft Loss (n=0, 1) | 0.500 score on a scale | — |
Secondary
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.
Time frame: Up to 12 months
Population: The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Participant Survival | CKD273:Visit 15: Survived (n=106, 102) | 0.276 score on a scale | Standard Deviation 0.3824 |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Participant Survival | CMV:Visit 13: Survived (n=101, 109) | 0.033 score on a scale | Standard Deviation 0.8008 |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Participant Survival | CKD273:Visit 6: Survived (n=111, 113) | 0.371 score on a scale | Standard Deviation 0.3591 |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Participant Survival | CMV:Visit 15: Survived (n=106, 102) | -0.073 score on a scale | Standard Deviation 0.6894 |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Participant Survival | CMV:Visit 6: Did not Survive (n=2, 1) | 1.150 score on a scale | Standard Deviation 1.3435 |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Participant Survival | Nephropathy:Visit 6: Did not Survive (n=2, 1) | 0.150 score on a scale | Standard Deviation 0.0707 |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Participant Survival | CKD273:Visit 13: Survived (n=101, 109) | 0.253 score on a scale | Standard Deviation 0.3711 |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Participant Survival | Nephropathy:Visit 6: Survived (n=111, 113) | 0.101 score on a scale | Standard Deviation 1.1851 |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Participant Survival | CMV:Visit 6: Survived (n=111, 113) | -0.025 score on a scale | Standard Deviation 0.9374 |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Participant Survival | Nephropathy:Visit 13: Did not Survive (n=1, 1) | 1.800 score on a scale | — |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Participant Survival | CKD273:Visit 13: Did not Survive (n=1, 1) | 0.700 score on a scale | — |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Participant Survival | Nephropathy:Visit 13: Survived (n=101, 109) | -0.068 score on a scale | Standard Deviation 1.0514 |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Participant Survival | CMV:Visit 13: Did not Survive (n=1, 1) | 0.400 score on a scale | — |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Participant Survival | Nephropathy:Visit 15: Survived (n=106, 102) | 0.019 score on a scale | Standard Deviation 0.9105 |
| Valganciclovir CMV Prophylaxis | Relationship Between Proteomics Pattern and Participant Survival | CKD273:Visit 6: Did not Survive (n=2, 1) | 0.400 score on a scale | Standard Deviation 0.1414 |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Participant Survival | Nephropathy:Visit 15: Survived (n=106, 102) | 0.102 score on a scale | Standard Deviation 1.1221 |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Participant Survival | CKD273:Visit 6: Did not Survive (n=2, 1) | 0.500 score on a scale | — |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Participant Survival | CKD273:Visit 6: Survived (n=111, 113) | 0.393 score on a scale | Standard Deviation 0.357 |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Participant Survival | CKD273:Visit 13: Did not Survive (n=1, 1) | 0.500 score on a scale | — |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Participant Survival | CKD273:Visit 13: Survived (n=101, 109) | 0.293 score on a scale | Standard Deviation 0.3648 |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Participant Survival | CKD273:Visit 15: Survived (n=106, 102) | 0.326 score on a scale | Standard Deviation 0.3618 |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Participant Survival | CMV:Visit 6: Did not Survive (n=2, 1) | -0.900 score on a scale | — |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Participant Survival | CMV:Visit 6: Survived (n=111, 113) | -0.010 score on a scale | Standard Deviation 0.8927 |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Participant Survival | CMV:Visit 13: Did not Survive (n=1, 1) | -0.300 score on a scale | — |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Participant Survival | CMV:Visit 13: Survived (n=101, 109) | -0.048 score on a scale | Standard Deviation 0.7614 |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Participant Survival | CMV:Visit 15: Survived (n=106, 102) | -0.068 score on a scale | Standard Deviation 0.7081 |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Participant Survival | Nephropathy:Visit 6: Did not Survive (n=2, 1) | -0.100 score on a scale | — |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Participant Survival | Nephropathy:Visit 6: Survived (n=111, 113) | 0.124 score on a scale | Standard Deviation 1.064 |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Participant Survival | Nephropathy:Visit 13: Did not Survive (n=1, 1) | -0.800 score on a scale | — |
| Pre-emptive CMV Therapy | Relationship Between Proteomics Pattern and Participant Survival | Nephropathy:Visit 13: Survived (n=101, 109) | 0.008 score on a scale | Standard Deviation 1.0848 |
Secondary
Time to Occurrence of First Viremia Within 12 Months
Viremia was defined as plasma PCR ≥ 400 copies/ml.
Time frame: Up to 12 months
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Valganciclovir CMV Prophylaxis | Time to Occurrence of First Viremia Within 12 Months | NA days |
| Pre-emptive CMV Therapy | Time to Occurrence of First Viremia Within 12 Months | NA days |
Secondary
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.
Time frame: Up to 12 months
Population: The intent-to-treat (ITT) population included all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Viral Burden at Viremia | 5309.83 copies/ml*days | Standard Deviation 14355.836 |
| Pre-emptive CMV Therapy | Viral Burden at Viremia | 3765.8 copies/ml*days | Standard Deviation 8480.521 |