- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01446445
Individualization of Ganciclovir and Valganciclovir Doses Using Bayesian Prediction in Renal Transplant Patients.
Individualization of Ganciclovir and Valganciclovir Doses in Renal Transplant Patients for Prophylaxis or Treatment of Cytomegalovirus(CMV)Infection Using Bayesian Prediction.
Study Overview
Status
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 model developed by our group, less than 16% of patients treated achieve the therapeutic goal of AUC (40 to 50 mcg • h / L) after drug dosing according to summary of product characteristics (SPC). Especially, patients with impaired renal function values (creatinine clearance (CrC)l <30 ml / min) or high (CrCl> 70 ml / min) would be overdosed and underdosed, respectively, with the risk of more adverse effects or therapeutic failure.
Therefore, the individualization of the dosage of GCV, can contribute greatly to achieve optimal exposure to the drug in transplant patients, especially in the cases of extreme values of renal function (CrCl decreased and high). As a consequence, minimize adverse effects, ensure greater efficiency in the target population and reduce associated costs.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, Spain, 08028
- Nephrology Department- Hospital Universitari Bellvtge
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1.A (Prophylaxis-SPC)
Prophylaxis for CMV infection and Ganciclovir/ Valganciclovir doses according to summaries of product characteristics (SPC).
|
Doses according to Summaries of Product Characteristics (SPC)
Other Names:
|
Experimental: 1.B (Prophylaxis- PK model)
Prophylaxis for CMV infection and Ganciclovir/Valganciclovir doses according to pharmacokinetic model.
|
Doses according to population pharmacokinetic model
Other Names:
|
Active Comparator: 2.A (Treatment-SPC)
Treatment for CMV infection/disease and Ganciclovir/ Valganciclovir doses according to summaries of product characteristics (SPC).
|
Doses according to Summaries of Product Characteristics (SPC)
Other Names:
|
Experimental: 2.B (Treatment-PK model)
Treatment for CMV infection/disease and Ganciclovir/Valganciclovir doses according to pharmacokinetic model
|
Doses according to population pharmacokinetic model
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the concentration time curve (AUC)of ganciclovir in steady state
Time Frame: Change from baseline to the end of the treatment, with an expected average of treatment of 4 weeks in treatment and 90 days in prophylaxis patients.
|
Values of AUC of ganciclovir achieved with each intervention, that is, ganciclovir and valganciclovir dose adjustment according to SPC(specific product characteristics) or PK (pharmacokinetic) model. In each intervention: after starting treatment, change in route of administration, change in renal clearance >10 mL/min and end of treatment blood sampling for pharmacokinetic analysis will be performed in order to calculate AUC. |
Change from baseline to the end of the treatment, with an expected average of treatment of 4 weeks in treatment and 90 days in prophylaxis patients.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CMV viral load measured by quantitative polymerase chain reaction (PCR)
Time Frame: Change from baseline to day 30 of study entry
|
CMV viral load will be correlated with the exposure to ganciclovir during treatment period, in both interventions.
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Change from baseline to day 30 of study entry
|
CMV viral load measured by quantitative polymerase chain reaction (PCR)
Time Frame: Change from baseline to day 60 of study entry
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CMV viral load will be correlated with the exposure to ganciclovir during treatment period, in both interventions.
|
Change from baseline to day 60 of study entry
|
CMV viral load measured by quantitative polymerase chain reaction (PCR)
Time Frame: Change from baseline to day 90 of study entry
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CMV viral load will be correlated with the exposure to ganciclovir during treatment period, in both interventions.
|
Change from baseline to day 90 of study entry
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T-cell immune response against CMV infection measured by Enzyme-linked immunosorbent spot (ELISPOT)
Time Frame: Change from day 40 of treatment to day 20 after end of treatment.
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In prophylaxis patients(arm 1.A and 1.B): ELISPOT assay will be performed to assess the immune response to CMV viral infection on day 40 of initial dose and on day 20 after end of prophylactic therapy.
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Change from day 40 of treatment to day 20 after end of treatment.
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T-cell immune response against CMV infection measured by Enzyme-linked immunosorbent spot (ELISPOT)
Time Frame: Change from baseline to day 20 of treatment
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In treatment patients(arm 2.A and 2.B): ELISPOT assay will be performed to assess the immune response to CMV viral infection at baseline, day 10 and 20 of treatment.
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Change from baseline to day 20 of treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nuria Lloberas, Ph.D, Nephrology Department-Hospital Universitari Bellvitge
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCV2010
- 2010-021433-32 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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