Kidney Transplant InfectionNCT03488771
Evaluation of Cell-mediated Immune Response by QuantiFERON Monitor® Assay in Kidney Transplant Recipients
An observational study of Kidney Transplant Infection and Kidney Transplant Rejection, run by Clinical Hospital Merkur at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Infection, Kidney Transplant Rejection
- How many people
- 150 participants
- Where
- 1 siteCroatia
- Study dates
- 5 Mar 2017to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Kidney transplant recipients
Who may be able to join
- Kidney/Liver kidney/Simultaneous pancreas and kidney transplantation
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Clinical Hospital Merkur
Zagreb, HR, 10000
Mladen Knotek, MD, 385994888231, mladen.knotek1@zg.t-com.hr
About this study
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.
- Keywords
- kidney transplantation, rejection, infection, immunosuppression
- Medical subject headings
- Rejection, Psychology, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Infection
Interferon gamma level in patients with infection
Measured: throughout the study period (Kidney transplant recipients from 1 day date of tx to 15 years after tx)
Secondary outcomes (1)
Rejection
Interferon gamma levels in patients with rejection
Measured: throughout the study period (Kidney transplant recipients from 1 day date of tx to 15 years after tx)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start5 Mar 2017
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Merkur
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Hospital Centre Zagreb
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488771
- Sponsor's protocol ID
- CHMerkurQFM
- Status last verified
- Apr 2018
- First submitted
- 22 Mar 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cell-mediated Immune Response by QuantiFERON Monitor® Assay in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT03488771
- Acronym / sponsor ID
- CHMerkurQFM
- Keywords
- kidney transplantation, rejection, infection, immunosuppression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Clinical Hospital MerkurUniversity, hospital or other
- Collaborators
- Clinical Hospital Centre Zagreb
- Study start
- 5 Mar 2017 (actual)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant recipients
Key inclusion criteria (1 listed)
- Kidney/Liver kidney/Simultaneous pancreas and kidney transplantation
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Rejection
Time frame: throughout the study period (Kidney transplant recipients from 1 day date of tx to 15 years after tx)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Infection and Kidney Transplant Rejection, run by Clinical Hospital Merkur at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ivan Margeta, MD (+385921384970, ivan.margeta@kb-merkur.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection (time frame: throughout the study period (Kidney transplant recipients from 1 day date of tx to 15 years after tx)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.