(Val)Ganciclovir TDM in Transplant Recipients

NCT ID: NCT03698435

Last Updated: 2019-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-25
• Study Completion Date: 2019-12-31

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.

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.

Conditions

Cytomegalovirus Infections

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Prophylaxis

Patients who receive (val)ganciclovir for prophylaxis of cytomegalovirus

Ganciclovir

Intervention Type: DRUG

Intravenous ganciclovir + TDM

Valganciclovir

Intervention Type: DRUG

Oral valganciclovir + TDM

Treatment

Patients who receive (val)ganciclovir for treatment of cytomegalovirus

Ganciclovir

Intervention Type: DRUG

Intravenous ganciclovir + TDM

Valganciclovir

Intervention Type: DRUG

Oral valganciclovir + TDM

Interventions

Ganciclovir

Intravenous ganciclovir + TDM

Intervention Type: DRUG

Valganciclovir

Oral valganciclovir + TDM

Intervention Type: DRUG

Other Intervention Names

Cymevene; Valcyte

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Jan-Willem C Alffenaar

Principal Investigator, Clinical pharmacologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan-Willem Alffenaar, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

UMCG

Groningen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Anne-Grete Märtson, MSc

Role: CONTACT

a.martson@umcg.nl

+37253325121

Marjolein Knoester, MD

Role: CONTACT

m.knoester@umcg.nl

+31503613480

Facility Contacts

JWC Alffenaar, PhD

Role: primary

Other Identifiers

201800021

Identifier Type: -

Identifier Source: org_study_id