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

NCT03488771 | Unknown

• 1 other identifier: CHMerkurQFM
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplant Infection; Kidney Transplant Rejection

Keywords

kidney transplantation; rejection; infection; immunosuppression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rejection

  throughout the study period (Kidney transplant recipients from 1 day date of tx to 15 years after tx)

Study Arms (3)

Control

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

Infection

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

Rejection

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant recipients

You may qualify if:

• Kidney/Liver kidney/Simultaneous pancreas and kidney transplantation

You may not qualify if:

• none

Sponsors & Collaborators

• Clinical Hospital Merkur: lead
• Clinical Hospital Centre Zagreb: collaborator

Study Sites (1)

Clinical Hospital Merkur

Zagreb, HR, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Rejection, Psychology; Infections

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Central Study Contacts

Ivan Margeta, MD

CONTACT

+385921384970; ivan.margeta@kb-merkur.hr

Study Design

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

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 5, 2018
• Study Start: March 5, 2017
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

CR (1)