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Trial record 52 of 101 for:    Valcyte

(Val)Ganciclovir TDM in Transplant Recipients

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ClinicalTrials.gov Identifier: NCT03698435
Recruitment Status : Recruiting
First Posted : October 8, 2018
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
Jan-Willem C Alffenaar, University Medical Center Groningen

Brief Summary:
The aim of this study is to gain more insight into therapeutic drug monitoring and thus the pharmacodynamics and pharmacokinetics of ganciclovir, in the context of prophylaxis and treatment of CMV infections, in order to provide the patient with an adequate dose.

Condition or disease Intervention/treatment
Cytomegalovirus Infections Drug: Ganciclovir Drug: Valganciclovir

Detailed Description:

Patients undergoing solid organ or stem cell transplantation are at risk of developing cytomegalovirus (CMV) infection or reactivation. The risk of CMV infection / reactivation and its severity depends on the CMV serostatus of donor and recipient. Valganciclovir (oral pro-drug of ganciclovir) prophylaxis is used to postpone CMV infection or reactivation to a later point in the post-transplantation.

CMV infection/reactivation does not always lead to clinical disease. Valganciclovir (oral) can be used when CMV DNA is detected in the blood, but patient has no or few complaints. However, in case of severe symptoms such as colitis, nephritis, hepatitis, pneumonitis, uveitis or encephalitis (active CMV disease) then ganciclovir is indicated intravenously. In clinical recovery treatment is often completed with valganciclovir.

It is important that the ganciclovir level is adequate, because too high level can lead to side effects such as cytopenia and a too low level can lead to treatment failure and resistance development. There are different dosing schedules mentioned in different sources. These schemes are based on dated literature.

The aim of (val)ganciclovir therapeutic drug monitoring (TDM) is to gain more insight into the pharmacodynamics and pharmacokinetics of ganciclovir, in the context of prophylaxis and treatment of CMV infections, in order to provide the patient with an adequate dose.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: (Val)Ganciclovir Therapeutic Drug Monitoring in Transplant Recipients
Actual Study Start Date : May 25, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019


Group/Cohort Intervention/treatment
Prophylaxis
Patients who receive (val)ganciclovir for prophylaxis of cytomegalovirus
Drug: Ganciclovir
Intravenous ganciclovir + TDM
Other Name: Cymevene

Drug: Valganciclovir
Oral valganciclovir + TDM
Other Name: Valcyte

Treatment
Patients who receive (val)ganciclovir for treatment of cytomegalovirus
Drug: Ganciclovir
Intravenous ganciclovir + TDM
Other Name: Cymevene

Drug: Valganciclovir
Oral valganciclovir + TDM
Other Name: Valcyte




Primary Outcome Measures :
  1. Failure of CMV treatment (with valganciclovir and ganciclovir) using viral load measurements and determining mutations in CMV kinase gene UL97 and DNA polymerase gene UL54 [ Time Frame: 12 months after transplantation ]
    How many days to the development of failure of treatment? Failure of treatment is defined by increased viral load (measured in serum, whole blood, plasma in copies per mL and/or viral resistance (change of ganciclovir treatment to foscarnet treatment as a consequence, resistance is determined by resistance testing determining CMV kinase gene UL97 and DNA polymerase gene UL54 for mutations) or death due to CMV.


Secondary Outcome Measures :
  1. Breakthrough CMV infection during CMV prophylaxis with valganciclovir [ Time Frame: 12 months after transplantation ]
    Breakthrough CMV infection during prophylaxis with valganciclovir, time (days) to development of breakthrough CMV infection during prophylaxis

  2. Therapeutic window [ Time Frame: 12 months after transplantation ]
    How many levels are in and out of the therapeutic window (how many low and high levels)?

  3. Successful treatment while receiving (val)ganciclovir determined by two consequtive negative viral loads [ Time Frame: 12 months after transplantation ]
    The proportion of patients from CMV treatment group who have a successful CMV treatment, successful CMV treatment is defined by viral load <100 copies/mL (measured twice in a row).

  4. (Val)ganciclovir for treatment outcomes (1) [ Time Frame: 12 months after transplantation ]
    The proportion of patients from CMV treatment group who are under-dosed

  5. (Val)ganciclovir for treatment outcomes (2) [ Time Frame: 12 months after transplantation ]
    The proportion of patients from CMV treatment group who develop resistance to ganciclovir

  6. Factors that can influence trough concentrations of (val)ganciclovir (1) [ Time Frame: 12 months after transplantation ]
    Does the type of transplanted organ (liver, lungs, kidney, heart, stem cell transplant) cause high or low (val)ganciclovir trough concentrations (mg/L)? Defined therapeutic window for prophylaxis is 1-2 mg/L and for therapy is 2-4 mg/L. Number of levels which are out of the therapeutic window for different transplants.

  7. Factors that can influence trough concentrations of (val)ganciclovir (2) [ Time Frame: 12 months after transplantation ]
    Does the underlying disease for transplantation cause high or low (val)ganciclovir trough concentrations (mg/L)? Defined therapeutic window for prophylaxis is 1-2 mg/L and for therapy is 2-4 mg/L. Number of levels which are out of the therapeutic window for different underlying diseases.

  8. Factors that can influence trough concentrations of (val)ganciclovir (3) [ Time Frame: 12 months after transplantation ]
    Does dose reduction for renal failure cause increase or decrease in (val)ganciclovir trough concentrations (mg/L)? Number of levels which are out of the therapeutic window after dose reduction.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing solid organ or stem cell transplantation are at risk of developing cytomegalovirus (CMV) infection or reactivation. Valganciclovir (oral pro-drug of ganciclovir) prophylaxis is used to postpone CMV infection or reactivation to a later point in the post-transplantation.
Criteria

Inclusion Criteria:

  • Must receive ganciclovir intravenously or valganciclovir orally as routine care
  • Must have received a solid organ or stem cell transplant
  • Must be be 18 years or older

Exclusion Criteria:

There are no exclusion criteria.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03698435


Contacts
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Contact: Anne-Grete Märtson, MSc +37253325121 a.martson@umcg.nl
Contact: Marjolein Knoester, MD +31503613480 m.knoester@umcg.nl

Locations
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Netherlands
UMCG Recruiting
Groningen, Netherlands
Contact: JWC Alffenaar, PhD         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: Jan-Willem Alffenaar, PhD University Medical Center Groningen

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Responsible Party: Jan-Willem C Alffenaar, Principal Investigator, Clinical pharmacologist, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03698435     History of Changes
Other Study ID Numbers: 201800021
First Posted: October 8, 2018    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jan-Willem C Alffenaar, University Medical Center Groningen:
ganciclovir
valganciclovir
therapeutic drug monitoring
pharmacokinetics

Additional relevant MeSH terms:
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Valganciclovir
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Ganciclovir
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action