TransplantNCT00436384
Cell Mediated Immunity and the Prediction of CMV Infection In Solid Organ Transplant Recipients
An observational study of Transplant, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Cytomegalovirus (CMV) is a common cause of illness in patients who have undergone a transplant. Serious infections due to CMV can affect many parts of the body including the lungs, the gut, and the liver. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant
- What is being tested?
- Monitoring-blood samples drawn for CMV testing
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2005to Mar 2008
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients who fulfill the following criteria are eligible for inclusion.
- CMV D+/R- liver, kidney and heart recipient
- CMV R+ liver,kidney and heart recipients who have received thymoglobulin induction therapy.
- D+/R- and R+ lung transplant recipients.
- Able to give written informed consent
- Are willing and able to comply with the protocol
- Age >=18 years
Who cannot join
- Patient unwilling or unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Cytomegalovirus (CMV) is a common cause of illness in patients who have undergone a transplant. Serious infections due to CMV can affect many parts of the body including the lungs, the gut, and the liver. Since transplant recipients are at risk for CMV or have evidence of infection with CMV, they are given an antiviral drug (usually ganciclovir or valganciclovir). Despite this, there are a chance that CMV infection may cause problems in the future. The purpose of this study is to assess how well patients'immune systems responds to the CMV virus, so that in the future it may be possible to predict which patients are at highest risk of CMV.
- Conditions
- Transplant
- Being tested
- Monitoring-blood samples drawn for CMV testing
- Keywords
- liver transplant, lung transplant, kidney transplant, heart transplant, CMV CMI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring-blood samples drawn for CMV testingProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startNov 2005
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransplantStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Investigators
- Atul Humar, MD, Principal investigator, University Health Network, TorontoDeepali Kumar, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436384
- Sponsor's protocol ID
- 05-0265-AE
- Status last verified
- Feb 2007
- First submitted
- 15 Feb 2007
- Last updated
- 16 Apr 2008
- Results posted
- No