Status:
COMPLETED
A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Cytomegalovirus Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 p...
Eligibility Criteria
Inclusion
- primary or secondary renal allograft within preceding 14 days;
- IgG seropositive for CMV;
- receiving immunosuppressive therapy.
Exclusion
- active CMV infection;
- current/history of malignancy;
- acute steroid resistant rejection episode since transplantation.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
299 Patients enrolled
Trial Details
Trial ID
NCT00372229
Start Date
May 1 2006
End Date
October 1 2015
Last Update
March 11 2020
Active Locations (24)
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1
Innsbruck, Austria, 6020
2
Vienna, Austria, 1090
3
Aachen, Germany, 52057
4
Berlin, Germany, 12203