Low-risk renal transplant patients
Conditions
Brief summary
Efficacy: proportion of patients with CMV disease (incidence) at 6 and 12 months after transplantation., Safety: proportion of patients with different degrees of neutropenia at 6 and 12 months after transplantation.
Detailed description
Safety: number of days with valganciclovir (at 6 and 12 months post-transplant) and proportion of patients with adverse events occurring at a frequency >10% (at 6 months post-transplant)., Efficacy/safety: CMV disease/neutropenia combination assessed at 6 and 12 months using DOOR ("Desirability of Outcome Ranking"). The best outcome is no CMV disease/replication without neutropenia (<1500 mm³), while the worst is CMV disease/replication with neutropenia. DOOR ranks patient outcomes and estimates the probability of a better result in one group. A >50% probability, with 95% confidence intervals excluding 50%, indicates a significantly better outcome.
Interventions
DRUGGanciclovir Accord 500 mg polvo para concentrado para solución para perfusión EFG
DRUGValganciclovir Normon 450 mg comprimidos recubiertos con película EFG
Sponsors
Fundacion Para La Investigacion Biomedica De Cordoba
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: proportion of patients with CMV disease (incidence) at 6 and 12 months after transplantation., Safety: proportion of patients with different degrees of neutropenia at 6 and 12 months after transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: number of days with valganciclovir (at 6 and 12 months post-transplant) and proportion of patients with adverse events occurring at a frequency >10% (at 6 months post-transplant)., Efficacy/safety: CMV disease/neutropenia combination assessed at 6 and 12 months using DOOR ("Desirability of Outcome Ranking"). The best outcome is no CMV disease/replication without neutropenia (<1500 mm³), while the worst is CMV disease/replication with neutropenia. DOOR ranks patient outcomes and estimates the probability of a better result in one group. A >50% probability, with 95% confidence intervals excluding 50%, indicates a significantly better outcome. | — |
Countries
Spain
Outcome results
None listed