NCT01446445

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 5, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

2.7 years

First QC Date

September 19, 2011

Last Update Submit

March 25, 2015

Conditions

Infection in Solid Organ Transplant Recipients

Keywords

Cytomegalovirusrenal transplant

Outcome Measures

Primary Outcomes (1)

  • Area under the concentration time curve (AUC)of ganciclovir in steady state

    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 Outcomes (5)

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

    Change from baseline to day 30 of study entry

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

    Change from baseline to day 60 of study entry

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

    Change from baseline to day 90 of study entry

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

    Change from day 40 of treatment to day 20 after end of treatment.

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

    Change from baseline to day 20 of treatment

Study Arms (4)

1.A (Prophylaxis-SPC)

ACTIVE COMPARATOR

Prophylaxis for CMV infection and Ganciclovir/ Valganciclovir doses according to summaries of product characteristics (SPC).

Drug: Ganciclovir/ Valganciclovir according to SPC

1.B (Prophylaxis- PK model)

EXPERIMENTAL

Prophylaxis for CMV infection and Ganciclovir/Valganciclovir doses according to pharmacokinetic model.

Drug: Ganciclovir/ Valganciclovir according to PK model

2.A (Treatment-SPC)

ACTIVE COMPARATOR

Treatment for CMV infection/disease and Ganciclovir/ Valganciclovir doses according to summaries of product characteristics (SPC).

Drug: Ganciclovir/ Valganciclovir according to SPC

2.B (Treatment-PK model)

EXPERIMENTAL

Treatment for CMV infection/disease and Ganciclovir/Valganciclovir doses according to pharmacokinetic model

Drug: Ganciclovir/ Valganciclovir according to PK model

Interventions

Ganciclovir/ Valganciclovir according to SPCDRUG

Doses according to Summaries of Product Characteristics (SPC)

Also known as: Cymevene and Valcyte doses calculated according to SPC
1.A (Prophylaxis-SPC)2.A (Treatment-SPC)
Ganciclovir/ Valganciclovir according to PK modelDRUG

Doses according to population pharmacokinetic model

Also known as: Cymevene and Valcyte doses calculated according to PK model
1.B (Prophylaxis- PK model)2.B (Treatment-PK model)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nephrology Department- Hospital Universitari Bellvtge

L'Hospitalet de Llobregat, Barcelona, 08028, Spain

Location

Related Publications (3)

  • Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4.

    PMID: 39807668DERIVED

  • Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.

    PMID: 38700045DERIVED

  • Padulles A, Colom H, Bestard O, Melilli E, Sabe N, Rigo R, Niubo J, Torras J, Llado L, Manito N, Caldes A, Cruzado JM, Grinyo JM, Lloberas N. Contribution of Population Pharmacokinetics to Dose Optimization of Ganciclovir-Valganciclovir in Solid-Organ Transplant Patients. Antimicrob Agents Chemother. 2016 Mar 25;60(4):1992-2002. doi: 10.1128/AAC.02130-15. Print 2016 Apr.

    PMID: 26824942DERIVED

MeSH Terms

Interventions

Ganciclovir

Intervention Hierarchy (Ancestors)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Nuria Lloberas, Ph.D

    Nephrology Department-Hospital Universitari Bellvitge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Investigator of Nephrology Department

Study Record Dates

First Submitted

September 19, 2011

First Posted

October 5, 2011

Study Start

December 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

March 27, 2015

Record last verified: 2015-03

Locations

ES(1)