Evaluation of Cell-mediated Immune Response by QuantiFERON Monitor® Assay in Kidney Transplant Recipients

Kidney Transplant Rejection Clinical Trial

Official title:

Evaluation of Cell-mediated Immune Response by QuantiFERON Monitor® Assay in Kidney Transplant Recipients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03488771
• Other study ID #: CHMerkurQFM
• Status: Recruiting
• First received: March 22, 2018
• Last updated: April 4, 2018
• Start date: March 5, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: April 2018
• Source: Clinical Hospital Merkur
• Contact: Ivan Margeta, MD
• Phone: +385921384970
• Email: ivan.margeta[@]kb-merkur.hr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

All kidney transplant recipients require immunosuppression, the net level of which is difficult to assess. Current practice in assessing immune reactivity is to monitor levels of some immunosuppressive drugs. QuantiFERON Monitor® (QFM) is an in vitro diagnostic test that detects interferon-γ (IFN-γ) release in peripheral blood. Its clinical utility in assessment of the net state of immunosuppression in kidney transplant recipients has not been well studied. The aim of our study is to evaluate the discriminating value of QFM testing results for infection and rejection in a single-centre cohort of kidney transplant recipients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Kidney/Liver kidney/Simultaneous pancreas and kidney transplantation

Exclusion Criteria:

Related Conditions & MeSH terms

• Kidney Transplant Infection
• Kidney Transplant Rejection

Locations

Country	Name	City	State
Croatia	Clinical Hospital Merkur	Zagreb	HR

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Hospital Merkur	Clinical Hospital Centre Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection	Interferon gamma level in patients with infection	throughout the study period (Kidney transplant recipients from 1 day date of tx to 15 years after tx)
Secondary	Rejection	Interferon gamma levels in patients with rejection	throughout the study period (Kidney transplant recipients from 1 day date of tx to 15 years after tx)