Status:
COMPLETED
Individualization of Ganciclovir and Valganciclovir Doses Using Bayesian Prediction in Renal Transplant Patients.
Lead Sponsor:
Nuria Lloberas
Collaborating Sponsors:
Ministerio de Sanidad, Servicios Sociales e Igualdad
Conditions:
Infection in Solid Organ Transplant Recipients
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of the present study is to optimize intravenous ganciclovir(GCV) and oral valganciclovir (VGCV)doses, advised by the drug exposure, indicated by the area under the concentration time cur...
Detailed Description
The area under the concentration time curve of serum concentrations of GCV is an indicator of systemic exposure to the drug and is related to the effectiveness and safety. According to the population ...
Eligibility Criteria
Inclusion
- Subjects must be 18 or older, weigh more than 34kg and may be of either sex and race.
- Subjects must be willing to give informed consent (IC) in writing and be able to do and follow the study. If a subject cannot give informed consent in writing , a legal representative could sign in his place.
- Women of childbearing potential should perform a pregnancy test at the time of entry and accept the use of a medically acceptable contraceptive method during the study.
Exclusion
- Creatinine Clearance (CrCl )\<10 mL / min.
- Subjects may not have a history of type I hypersensitivity or idiosyncratic reactions to drugs ganciclovir/valganciclovir
- Pregnancy women.
- Women breast feeding
- Subjects may not present at time of inclusion any clinically significant disease that could interfere with study evaluations.
- Previous participation in another clinical trial sponsored by pharmaceutical industry, in which the promoter and the protocol set which should be the treatment for CMV.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01446445
Start Date
December 1 2011
End Date
August 1 2014
Last Update
March 27 2015
Active Locations (1)
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1
Nephrology Department- Hospital Universitari Bellvtge
L'Hospitalet de Llobregat, Barcelona, Spain, 08028