- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03488771
Evaluation of Cell-mediated Immune Response by QuantiFERON Monitor® Assay in Kidney Transplant Recipients
April 4, 2018 updated by: Clinical Hospital Merkur
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.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ivan Margeta, MD
- Phone Number: +385921384970
- Email: ivan.margeta@kb-merkur.hr
Study Locations
-
-
HR
-
Zagreb, HR, Croatia, 10000
- Recruiting
- Clinical Hospital Merkur
-
Contact:
- Mladen Knotek, MD
- Phone Number: 385994888231
- Email: mladen.knotek1@zg.t-com.hr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Kidney transplant recipients
Description
Inclusion Criteria:
- Kidney/Liver kidney/Simultaneous pancreas and kidney transplantation
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infection
Time Frame: throughout the study period (Kidney transplant recipients from 1 day date of tx to 15 years after tx)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rejection
Time Frame: throughout the study period (Kidney transplant recipients from 1 day date of tx to 15 years after tx)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 5, 2017
Primary Completion (Anticipated)
June 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
March 22, 2018
First Submitted That Met QC Criteria
April 4, 2018
First Posted (Actual)
April 5, 2018
Study Record Updates
Last Update Posted (Actual)
April 5, 2018
Last Update Submitted That Met QC Criteria
April 4, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHMerkurQFM
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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