Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Kidney Transplant Recipients

Kidney Transplantation Recipients Clinical Trial

— ACE-KT  

Official title:

Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Kidney Transplant Recipients (ACE-KT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025335
• Other study ID #: 2013-1040
• Secondary ID: 2013-1040
• Status: Completed
• Phase: N/A
• First received: December 16, 2013
• Last updated: September 24, 2015
• Start date: March 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

CMV is one of the most important opportunistic infection in transplant recipients. In South Korea, more than 95% of adults reveal sero-positivity for CMV IgG. Until now, sero-positivity for CMV IgG before solid organ transplantation is a laboratory test of choice to stratify the risk of CMV reactivation after solid organ transplantation. Theoretically, CMV-specific cell-mediate immune response before solid organ transplantation will further categorize the patients into high or low risk of CMV development after solid organ transplantation. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in kidney transplant candidates to predict the development of CMV infection after kidney transplantation.

Description:

Between Mar 2014 and Mar 2015, all patients admitted in the kidney transplant unit will be enrolled in this study. All patients will receive CMV-specific ELISPOT assay and be prospectively followed for the development of CMV infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 90 Years

Eligibility

Inclusion Criteria:

• age 16 or more

• agree with written informed consent

Exclusion Criteria:

• donor CMV IgG (+) and recipient CMV IgG (-)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cytomegalovirus Infections
• Kidney Transplantation Recipients

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CMV infection	CMV infection is defined as follows.; CMV viremia: CMV antigenemia or CMV quantitative PCR (+); CMV disease: CMV syndrome or tissue-invasive CMV disease i) CMV syndrome: ? CMV viremia ? temperature > 38 without other cause ? WBC < 4000, atypical lymphocyte > 3%, transaminase elevation, platelet < 100,000/mm ii) tissue-invasive CMV disease: evidence of CMV in histopathologic specimen (inclusion body or viral antigen in biopsy or bronchoalveolar lavage fluid)	6 months after transplantation	No
Secondary	mortality		6 months after transplantation	No
Secondary	rejection		6 months after transplantation	No
Secondary	graft loss		6 months after transplantation	No