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Pharmacokinetics of Valganciclovir in Kidney Transplant Recipients
NCT00034385Phase 4
Key facts
- Status
- Completed
- Start
- Apr 2002
- Primary completion
- Jan 2007
- Countries
- 1
- Sponsor
- National Institutes of Health
- Modality
- Small Molecules
- Drugs
- valganciclovir
- Conditions
- cytomegalovirus infection (CMV)
01
Overview
Phase 4, open-label, single-arm trial of valganciclovir in cytomegalovirus infection (CMV), sponsored by National Institutes of Health. Primary endpoint: Area Under the Curve at 24 hours. Started Apr 2002; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Sequential Dosing
Patients receive IV ganciclovir, then high-dose valganciclovir, then low-dose valganciclovir, then oral ganciclovir sequentially.
03
Endpoints
Primary
Area Under the Curve
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