NCT00677482

Brief Summary

Cytomegalovirus (CMV) is the most common viral infection 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. The purpose of this study is to assess how the virus interacts with the patient's immune system, so that in the future it may be possible to develop better ways to prevent and treat the virus infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

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

Study Start

First participant enrolled

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2008

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2013

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2015

Enrollment Period

4.3 years

First QC Date

May 12, 2008

Last Update Submit

May 26, 2022

Conditions

Keywords

liver transplantlung transplantkidney transplantheart transplantCMV microRNA

Study Arms (1)

1

Solid organ transplant recipients with both asymptomatic CMV viremia, and symptomatic CMV disease are eligible for inclusion in the study. THis includes liver, kidney, heart, pancreas, lung, intestinal and combined transplant recipients.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Solid organ tranplant recipients with both asymptomatic CMV viremia and symptomatic CMV disease are eligible for inclusion in the study. This include liver, kidney, heart, pancreas, lung, intestinal and combined transplant recipients.

You may qualify if:

  • Age \>=18 years
  • Solid Organ Transplant Recipients
  • Documented CMV disease or asymptomatic CMV viremia

You may not qualify if:

  • Unable to comply with protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G-2E1, Canada

Location

Related Publications (5)

  • Gandhi MK, Khanna R. Human cytomegalovirus: clinical aspects, immune regulation, and emerging treatments. Lancet Infect Dis. 2004 Dec;4(12):725-38. doi: 10.1016/S1473-3099(04)01202-2.

    PMID: 15567122BACKGROUND
  • Preiksaitis JK, Brennan DC, Fishman J, Allen U. Canadian society of transplantation consensus workshop on cytomegalovirus management in solid organ transplantation final report. Am J Transplant. 2005 Feb;5(2):218-27. doi: 10.1111/j.1600-6143.2004.00692.x.

    PMID: 15643981BACKGROUND
  • Humar A, Kumar D, Boivin G, Caliendo AM. Cytomegalovirus (CMV) virus load kinetics to predict recurrent disease in solid-organ transplant patients with CMV disease. J Infect Dis. 2002 Sep 15;186(6):829-33. doi: 10.1086/342601. Epub 2002 Aug 28.

    PMID: 12198618BACKGROUND
  • Rasmussen L. Molecular pathogenesis of human cytomegalovirus infection. Transpl Infect Dis. 1999 Jun;1(2):127-34. doi: 10.1034/j.1399-3062.1999.010206.x.

    PMID: 11428980BACKGROUND
  • Tomasec P, Wang EC, Davison AJ, Vojtesek B, Armstrong M, Griffin C, McSharry BP, Morris RJ, Llewellyn-Lacey S, Rickards C, Nomoto A, Sinzger C, Wilkinson GW. Downregulation of natural killer cell-activating ligand CD155 by human cytomegalovirus UL141. Nat Immunol. 2005 Feb;6(2):181-8. doi: 10.1038/ni1156. Epub 2005 Jan 9.

    PMID: 15640804BACKGROUND

Study Officials

  • Atul Humar, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2008

First Posted

May 14, 2008

Study Start

April 1, 2008

Primary Completion

July 27, 2012

Study Completion

September 23, 2013

Last Updated

June 1, 2022

Record last verified: 2015-05

Locations