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Completed

NCT Number: NCT01446445

Individualization of Ganciclovir and Valganciclovir Doses Using Bayesian Prediction in Renal Transplant Patients.

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 curve (AUC), in renal transplant patients receiving oral VGCV or intravenous GCV for CMV prophylaxis or treatment. The initial doses will be calculated according to population pharmacokinetic model. Subsequent doses will be adjusted according to plasma GCV concentrations, using the Bayesian approach. This method of dose adjustments could lead to increase the percentage of patients achieving a therapeutic exposure.

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Key information

Conditions

Infection in Solid Organ Transplant Recipients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nephrology Department- Hospital Universitari Bellvtge

L'Hospitalet de Llobregat, Barcelona, 08028, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ganciclovir/ Valganciclovir according to SPC

Drug

Doses according to Summaries of Product Characteristics (SPC)

Other names: Cymevene and Valcyte doses calculated according to SPC

Ganciclovir/ Valganciclovir according to PK model

Drug

Doses according to population pharmacokinetic model

Other names: Cymevene and Valcyte doses calculated according to PK model

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. CMV viral load measured by quantitative polymerase chain reaction (PCR)

    Time frame: Change from baseline to day 60 of study entry

    CMV viral load will be correlated with the exposure to ganciclovir during treatment period, in both interventions.

  3. CMV viral load measured by quantitative polymerase chain reaction (PCR)

    Time frame: Change from baseline to day 90 of study entry

    CMV viral load will be correlated with the exposure to ganciclovir during treatment period, in both interventions.

  4. 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.

    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.

  5. T-cell immune response against CMV infection measured by Enzyme-linked immunosorbent spot (ELISPOT)

    Time frame: Change from baseline to day 20 of treatment

    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.

Sponsors and collaborators

Lead sponsor

Nuria Lloberas

Other

Collaborators

  • Ministerio de Sanidad, Servicios Sociales e Igualdad

Registry information

Official study title

Individualization of Ganciclovir and Valganciclovir Doses in Renal Transplant Patients for Prophylaxis or Treatment of Cytomegalovirus(CMV)Infection Using Bayesian Prediction.

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 5, 2011
Registry last updated
Mar 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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