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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03488771
Other study ID # CHMerkurQFM
Secondary ID
Status Recruiting
Phase
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
Health authority
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:

Study Design


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)
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