Phase 3
N=326
IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients
Cytomegalovirus Infections
Bottom Line
View on ClinicalTrials.gov: NCT00294515 ↗Enrolled (actual)
326
Serious AEs
53.8%
Results posted
Jul 2010
Primary outcome: Primary: Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant — 43.6; 23.9 Percentage of patients — p=<=0.0002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Valganciclovir (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant |
43.6; 23.9 | <=0.0002 sig |
| SECONDARY Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant |
36.2; 10.3 | <0.0001 sig |
| SECONDARY Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant |
43.6; 22.6 | 0.0001 sig |
| SECONDARY Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant |
47.9; 34.2 | 0.0126 sig |
| SECONDARY Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant |
48.5; 34.2 | 0.0100 sig |
Summary
This study will determine the relative efficacy and safety of up to 100 days Valcyte prophylaxis relative to up to 200 days Valcyte prophylaxis when given for the prevention of CMV disease in high-risk (D+/R-) kidney allograft recipients. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Eligibility Criteria
Inclusion Criteria
- ≥ 16 years of age
- CMV seronegative recipient of primary or secondary renal allograft from a living or cadaveric seropositive donor
- Adequate hematological and renal function
- Patients and partners must agree to maintain effective birth control for 90 days following cessation of study medication
Exclusion Criteria
- CMV disease, or receipt of anti-CMV therapy within 30 days prior to screening
- Multi-organ transplant recipient
- Hepatitis B, hepatitis C or HIV positive
- Women who are pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT00294515). 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.