Liver DiseaseNCT01764581
Randomized Controlled Trial of ImmuKnow in Liver Transplantation
A study testing Tacrolimus regulation according to ImmuKnow values in people with Liver Disease, run by University of Bologna.
Trial summary
ImmuKnow detects cell-mediated immunity in solid-organ transplant recipients undergoing immunosuppressive therapy. Increasing ImmuKnow values indicate a decrease of immunosuppression and decreasing ImmuKnow values suggest an increase of immunosuppression. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Disease
- What is being tested?
- Tacrolimus regulation according to ImmuKnow values
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Mar 2012
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- consecutive adult liver transplant recipients at our center;
- patients not entered into other studies;
- provided consent.
Who cannot join
- available follow-up;
- consent removed.
About this study
Official title: Randomized Controlled Interventional Trial of Immunosuppression Modification Based on the Cylex™ ImmuKnow® Assay in Adult Liver Transplant Recipients
ImmuKnow detects cell-mediated immunity in solid-organ transplant recipients undergoing immunosuppressive therapy. Increasing ImmuKnow values indicate a decrease of immunosuppression and decreasing ImmuKnow values suggest an increase of immunosuppression. The test measures the amount of ATP produced in CD4+ lymphocytes as a biomarker of lymphocyte activation. This study uses the ImmuKnow assay to proactively adjust immunosuppressive therapy in adult liver transplant recipients to reduce the risk of adverse events
Read the detailed description
We performed a randomized prospective interventional trial where the Interventional group had immunosuppression modified according to ImmuKnow values. Immunosuppression was decreased by 25% if ImmuKnow values were less than 130 ng/mL ATP. Similarly, immunosuppression was increased by 25% if ImmuKnow values were greater than 450 ng/mL ATP. Immunosuppression of the Control group was managed by the Standard of Care at our institution. ImmuKnow was performed before liver transplant, after surgery and at each clinic visit with the approximate schedule: day 1; weekly, weeks 1-4; week 6; week 8; monthly, months 3-6; and months 9 and 12. ImmuKnow testing was repeated within 7 days of a suspected/confirmed rejection or infection and again within 1 week of resolution.
- Conditions
- Liver Disease
- Being tested
- Tacrolimus regulation according to ImmuKnow values
- Keywords
- immune monitoring, immune cell function ImmuKnow, randomized controlled trial, immunosuppression management, infection, rejection, liver transplantation, Cylex
- Medical subject headings
- Liver Diseases, Infections, Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus regulation according to ImmuKnow valuesProcedure or surgery
Also called Prograf
Tacrolimus dose was reduced by 25% when ImmuKnow values were below 130 ng/mL ATP and increased by 25% when ImmuKnow values exceeded 450 ng/mL. Further reductions or increases were made after serial measures until ImmuKnow values stabilized between 130 and 450 ng/mL ATP. The values of 130 and 450 ng/mL ATP were previously documented as thresholds for risks of infection and rejection, respectively with a value of 280 ng/mL corresponding with the greatest negative predictive value for either event
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus dose regulation | Experimental | Tacrolimus dose was reduced by 25% when ImmuKnow values were below 130 ng/mL ATP and increased by 25% when ImmuKnow values exceeded 450 ng/mL. Receives: Procedure: Tacrolimus regulation according to ImmuKnow values |
| Control | No intervention | immunosuppressive therapy is managed either by standard practice at our center (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of adverse events
Comparison of adverse events consisting of allograft rejection, severe infections, graft loss and death between the Control and Interventional groups
Measured: 12 months posttransplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startJul 2008
- Primary completionOct 2010
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Ravaioli, University of Bologna
- Investigators
- Antonio Daniele Pinna, MD, Study director, Department of General Surgery and Transplantation; S.Orsola-Malpighi Hospital, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764581
- Sponsor's protocol ID
- BolognaCylex01
- Status last verified
- Oct 2010
- First submitted
- 2 Jan 2013
- Last updated
- 9 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ravaioli M, Neri F, Lazzarotto T, Bertuzzo VR, Di Gioia P, Stacchini G, Morelli MC, Ercolani G, Cescon M, Chiereghin A, Del Gaudio M, Cucchetti A, Pinna AD. Immunosuppression Modifications Based on an Immune Response Assay: Results of a Randomized, Controlled Trial. Transplantation. 2015 Aug;99(8):1625-32. doi: 10.1097/TP.0000000000000650.
PubMed 25757214
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Interventional Trial of Immunosuppression Modification Based on the Cylex™ ImmuKnow® Assay in Adult Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT01764581
- Acronym / sponsor ID
- BolognaCylex01
- Conditions
- Liver Disease
- Keywords
- immune monitoring, immune cell function ImmuKnow, randomized controlled trial, immunosuppression management, infection, rejection, liver transplantation, Cylex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 9 Jan 2013 (estimated)
- 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.
ImmuKnow detects cell-mediated immunity in solid-organ transplant recipients undergoing immunosuppressive therapy. Increasing ImmuKnow values indicate a decrease of immunosuppression and decreasing ImmuKnow values suggest an increase of immunosuppression. The test measures the amount of ATP produced in CD4+ lymphocytes as a biomarker of lymphocyte activation. This study uses the ImmuKnow assay to proactively adjust immunosuppressive therapy in adult liver transplant recipients to reduce the risk of adverse events
Detailed description
We performed a randomized prospective interventional trial where the Interventional group had immunosuppression modified according to ImmuKnow values. Immunosuppression was decreased by 25% if ImmuKnow values were less than 130 ng/mL ATP. Similarly, immunosuppression was increased by 25% if ImmuKnow values were greater than 450 ng/mL ATP. Immunosuppression of the Control group was managed by the Standard of Care at our institution. ImmuKnow was performed before liver transplant, after surgery and at each clinic visit with the approximate schedule: day 1; weekly, weeks 1-4; week 6; week 8; monthly, months 3-6; and months 9 and 12. ImmuKnow testing was repeated within 7 days of a suspected/confirmed rejection or infection and again within 1 week of resolution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus dose regulation | Experimental | Procedure: Tacrolimus regulation according to ImmuKnow valuesTacrolimus dose was reduced by 25% when ImmuKnow values were below 130 ng/mL ATP and increased by 25% when ImmuKnow values exceeded 450 ng/mL. |
| Control | No intervention | –immunosuppressive therapy is managed either by standard practice at our center (Control) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- consecutive adult liver transplant recipients at our center;
- patients not entered into other studies;
- provided consent.
Key exclusion criteria (2 listed)
- available follow-up;
- consent removed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tacrolimus regulation according to ImmuKnow valuesAlso: PrografTacrolimus dose was reduced by 25% when ImmuKnow values were below 130 ng/mL ATP and increased by 25% when ImmuKnow values exceeded 450 ng/mL. Further reductions or increases were made after serial measures until ImmuKnow values stabilized between 130 and 450 ng/mL ATP. The values of 130 and 450 ng/mL ATP were previously documented as thresholds for risks of infection and rejection, respectively with a value of 280 ng/mL corresponding with the greatest negative predictive value for either event | Procedure or surgery | Tacrolimus dose regulation |
Primary outcome
Comparison of adverse events
Time frame: 12 months posttransplant
Comparison of adverse events consisting of allograft rejection, severe infections, graft loss and death between the Control and Interventional groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2013.
- Derived from this study: PubMed 25757214Ravaioli M, Neri F, Lazzarotto T, Bertuzzo VR, Di Gioia P, Stacchini G, Morelli MC, Ercolani G, Cescon M, Chiereghin A, Del Gaudio M, Cucchetti A, Pinna AD. Immunosuppression Modifications Based on an Immune Response Assay: Results of a Randomized, Controlled Trial. Transplantation. 2015 Aug;99(8):1625-32. doi: 10.1097/TP.0000000000000650.
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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.
Antonio Daniele Pinna, MD study director
Department of General Surgery and Transplantation; S.Orsola-Malpighi Hospital, University of Bologna
Questions about this trial
What is this clinical trial studying?
A study testing Tacrolimus regulation according to ImmuKnow values in people with Liver Disease, run by University of Bologna.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 9 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of adverse events (time frame: 12 months posttransplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01764581, which also lists 1 linked publication.
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 9 Jan 2013.