Phase 3
N=299
A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation
Cytomegalovirus Infections
Bottom Line
View on ClinicalTrials.gov: NCT00372229 ↗Enrolled (actual)
299
Serious AEs
63.6%
Results posted
Mar 2020
Primary outcome: Primary: Percentage of Participants With Active Cytomegalovirus (CMV) Infection Within 12 Months — 14.1; 42.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Valganciclovir CMV Prophylaxis (Drug); Valganciclovir (Pre-emptive CMV Therapy) (Drug); Ganciclovir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Active Cytomegalovirus (CMV) Infection Within 12 Months |
14.1; 42.6 | — |
| PRIMARY Percentage of Participants With CMV Disease Within 12 Months Including CMV Syndrome and Tissue Invasive Disease |
5.6; 16.9 | — |
| PRIMARY Urine Proteomic Pattern at Month 12 |
-0.1057; 0.1452 | 0.1739 |
| PRIMARY Percentage of Participants With Graft Loss at Month 84 |
7.43; 8.61 | — |
| SECONDARY Percentage of Participants With CMV Syndrome Within 12 Months |
5.6; 14.6 | — |
| SECONDARY Percentage of Participants With CMV Tissue Invasive Disease Within 12 Months |
3.3; 3.6 | — |
| SECONDARY Time to Occurrence of First Viremia Within 12 Months |
NA; NA | — |
| SECONDARY Viral Burden at Viremia |
5309.83; 3765.8 | — |
| SECONDARY Creatinine Clearance at Month 12 |
61.1; 61.3 | — |
| SECONDARY Percentage of Participants With at Least One Treated and Biopsy-Proven Acute Rejection Episode Within 12 Months |
18.2; 13.2 | — |
| SECONDARY Days of Hospitalization |
26.5; 32 | — |
| SECONDARY Relationship Between Proteomics Pattern and Graft Survival |
0.400; 0.800; 0.371; 0.379; 0.500; 0.258 | — |
| SECONDARY Relationship Between Proteomics Pattern and Participant Survival |
0.400; 0.500; 0.371; 0.393; 0.700; 0.500 | — |
| SECONDARY Proteomics Parameter: CKD273 |
0.372; 0.394; 0.258; 0.295; 0.276; 0.326 | — |
| SECONDARY Proteomics Parameter: CMV |
-0.004; -0.018; 0.036; -0.05; -0.073; -0.068 | — |
| SECONDARY Proteomics Parameter: Nephropathy |
0.102; 0.122; -0.05; 0.001; 0.019; 0.102 | — |
| SECONDARY Percentage of Participants Surviving at Month 12 |
98; 98.7 | — |
| SECONDARY Percentage of Participants With Graft Survival at Month 12 |
98.6; 96.0 | — |
| SECONDARY Percentage of Participants With Leukopenia Within 12 Months |
35.1; 26.5 | — |
| SECONDARY Percentage of Participants With Neutropenia Within 12 Months |
16.9; 12.6 | — |
| SECONDARY Percentage of Participants With Any Opportunistic Infection Within 12 Months |
31.1; 37.7 | — |
| SECONDARY Percentage of Participants With Post-Transplant Diabetes Mellitus |
2.7; 1.3; 3.4; 0.7 | — |
| SECONDARY Percentage of Participants With Active CMV Infections Not Responding to Valganciclovir or IV Ganciclovir Treatment |
11.8; 18.3 | — |
| SECONDARY Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84 |
16; 59; 16; 59; 16; 59 | — |
| SECONDARY Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84 |
7; 23; 7; 23; 7; 23 | — |
| SECONDARY Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84 |
7; 20; 7; 20; 7; 20 | — |
| SECONDARY Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84 |
4; 5; 4; 5; 4; 5 | — |
| SECONDARY Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84 |
16; 59; 16; 59; 16; 59 | — |
| SECONDARY Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84 |
7; 23; 7; 23; 7; 23 | — |
| SECONDARY Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84 |
97.97; 94.70; 95.95; 94.04; 94.59; 93.38 | — |
| SECONDARY Number of Participants Who Died From Months 24 to Month 84 |
3; 8; 6; 9; 8; 10 | — |
| SECONDARY Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84 |
97.30; 94.70; 97.30; 93.38; 96.62; 93.38 | — |
| SECONDARY Number of Participants Who Had Lost Their Transplant up to Month 84 |
4; 8; 4; 10; 5; 10 | — |
| SECONDARY Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84 |
0; 5; 0; 7; 0; 7 | — |
| SECONDARY Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84 |
4; 3; 4; 3; 5; 3 | — |
| 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 |
8.3; 11.5 | — |
| 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 |
17.9; 5.8 | — |
| SECONDARY Number of Participants Who Had Lost Their Transplant or Died up to Month 84 |
7; 15; 9; 18; 12; 19 | — |
| SECONDARY Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84 |
95.27; 90.07; 93.92; 88.08; 91.89; 87.42 | — |
| 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 |
26; 27; 65; 52; 15; 13 | — |
| 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 |
39; 48; 20; 27; 42; 51 | — |
| SECONDARY Creatinine Clearance at Month 24 and Every 12 Months up to Month 84 |
63.2; 62.9; 63.9; 64.5; 63.1; 62.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- primary or secondary renal allograft within preceding 14 days;
- IgG seropositive for CMV;
- receiving immunosuppressive therapy.
Exclusion Criteria
- active CMV infection;
- current/history of malignancy;
- acute steroid resistant rejection episode since transplantation.
Data sourced from ClinicalTrials.gov (NCT00372229). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.