Individualization of Ganciclovir and Valganciclovir Doses Using Bayesian Prediction in Renal Transplant Patients.
Infection in Solid Organ Transplant Recipients
About this trial
This is an interventional treatment trial for Infection in Solid Organ Transplant Recipients focused on measuring Cytomegalovirus, renal transplant
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Nephrology Department- Hospital Universitari Bellvtge
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Active Comparator
Experimental
1.A (Prophylaxis-SPC)
1.B (Prophylaxis- PK model)
2.A (Treatment-SPC)
2.B (Treatment-PK model)
Prophylaxis for CMV infection and Ganciclovir/ Valganciclovir doses according to summaries of product characteristics (SPC).
Prophylaxis for CMV infection and Ganciclovir/Valganciclovir doses according to pharmacokinetic model.
Treatment for CMV infection/disease and Ganciclovir/ Valganciclovir doses according to summaries of product characteristics (SPC).
Treatment for CMV infection/disease and Ganciclovir/Valganciclovir doses according to pharmacokinetic model