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

NCT ID: NCT03488771

Last Updated: 2018-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-05

Study Completion Date

2018-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Transplant Infection Kidney Transplant Rejection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Kidney transplant recipients without clinical/laboratory/biopsy signs of infection or graft rejection

No interventions assigned to this group

Infection

Kidney transplant recipients presenting with clinical or laboratory signs of infection (bacterial or viral)

No interventions assigned to this group

Rejection

Kidney transplant recipients presenting with clinical, laboratory or biopsy signs of graft rejection.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Kidney/Liver kidney/Simultaneous pancreas and kidney transplantation

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Hospital Centre Zagreb

OTHER

Sponsor Role collaborator

Clinical Hospital Merkur

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Hospital Merkur

Zagreb, HR, Croatia

Site Status RECRUITING

Countries

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Croatia

Central Contacts

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Ivan Margeta, MD

Role: CONTACT

+385921384970

Facility Contacts

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Mladen Knotek, MD

Role: primary

385994888231

Other Identifiers

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CHMerkurQFM

Identifier Type: -

Identifier Source: org_study_id

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