Renal Failure Chronic Requiring DialysisNCT02630537
Validation of Lophius Kits T-Track® CMV and T-Track® EBV in Hemodialysis Patients
An observational study of Renal Failure Chronic Requiring Dialysis, run by Lophius Biosciences GmbH.
Trial summary
Cell-mediated immunity (CMI) and in particular T cells play a critical role in the rejection of transplanted organs. Thus, in transplant recipients a life-long and individualized immunosuppressive medication is required to avoid graft rejection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure Chronic Requiring Dialysis
- How many people
- 133 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Sep 2012
- 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: Patient being hemodialysis-dependent due to end-stage kidney disease
Who may be able to join
- Patient being hemodialysis-dependent due to end-stage kidney disease
- Male or female patient at least 18 years of age
- Written informed consent
Who cannot join
- Patient requires ongoing dosing with a systemic immunosuppressive drug
- Patient has received immunosuppressive therapy within the last three month
- Patient is known to be positive for HIV or suffering from chronic hepatitis infections
- Patient has significant uncontrolled concomitant infections or other unstable medical conditions that could interfere with the study objectives
- Patient has any form of substance abuse, psychiatric disorder or condition that, in the opinion of the investigator may invalidate communication with the investigator
About this study
Official title: Clinical Validation of Lophius Kits T-Track® CMV and T-Track® EBV to Assess the Functionality of Cell-mediated Immunity (CMI) in Hemodialysis Patients
Cell-mediated immunity (CMI) and in particular T cells play a critical role in the rejection of transplanted organs. Thus, in transplant recipients a life-long and individualized immunosuppressive medication is required to avoid graft rejection. However, a too weak suppression of CMI causes acute and chronic graft damage leading to transplant loss, whereas a too potent suppression of CMI supports opportunistic infections and reactivation of persistent viruses.
One of the biggest challenges in the field of transplantation is to provide a personalized immunosuppressive and antiviral therapy based on reliable assessment and monitoring of CMI. This could lead to a reduction of graft rejections and virus reactivations in transplant recipients.
Read more
With the development of both assays T-Track® CMV and T-Track® EBV, Lophius Biosciences GmbH has implemented its novel proprietary T-activation technology for an improved assessment of the functionality of CMI in cytomegalovirus (CMV)- and/or Epstein-Barr virus (EBV)-seropositive individuals. In contrast to other existing systems the Lophius assays open up the opportunity to characterize the functionality of CMI as an entire network.
The planned clinical multicenter study aims to verify the suitability of the two assays for a reliable assessment of the functionality of CMI.
Hemodialysis patients have been identified as an appropriate patient cohort for investigating the clinical sensitivity of the Lophius assays as these patients closely resemble kidney transplant recipients prior to an immunosuppressive therapy.
The determination of the functional CMI in the course of an immunosuppressive treatment may in future enable physicians to optimize the individual immunosuppressive and antiviral therapy in transplant recipients to reduce the risk of rejection as well as virus reactivations and associated diseases.
- Conditions
- Renal Failure Chronic Requiring Dialysis
- Keywords
- Cytomegalovirus, Epstein- Barr virus, Cell-mediated immunity, T-Track® CMV, T-Track® EBV, hemodialysis, ELISpot
- Medical subject headings
- Epstein-Barr Virus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of CMV or EBV seropositive hemodialysis patients showing significant numbers of functional CMV or EBV-protein-reactive blood leucocytes applying T-Track® CMV or T-Track® EBV
Determination of the clinical sensitivity of T-Track® CMV and T-Track® EBV. T-Track® assays are based on the stimulation of peripheral blood mononuclear cells (PBMC) with preselected immunodominant T-activated proteins derived from the human Cytomegalovirus (CMV) and the Epstein-Barr-Virus (EBV) and the subsequent quantification of IFN-gamma producing blood leucocytes (Lophius biomarker for assessing the functionality of CMI) applying ELISpot technology.
Measured: 1 day
Secondary outcomes (1)
Percentage of CMV or EBV seropositive hemodialysis patients showing significant numbers of functional CMV or EBV-protein-reactive blood leucocytes applying EBV and CMV peptide-loaded Pro5® Pentamers and the Quantiferon® CMV assay
The comparison of the suitability of T-Track® CMV and T-Track® EBV to EBV and CMV peptide-loaded Pro5® Pentamers and the Quantiferon® CMV assay (commercially available competing products)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startOct 2011
- Primary completionSep 2012
- Study completionSep 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 Renal Failure Chronic Requiring DialysisStudies 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
- Cross-sectional
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lophius Biosciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernhard Banas, Prof., Principal investigator, University Hospital Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630537
- Sponsor's protocol ID
- LB-A1 (UREA-CMV-EBV)
- Status last verified
- Dec 2015
- First submitted
- 7 Dec 2015
- Last updated
- 15 Dec 2015
- Results posted
- No
Publications
Banas B, Boger CA, Luckhoff G, Kruger B, Barabas S, Batzilla J, Schemmerer M, Kostler J, Bendfeldt H, Rascle A, Wagner R, Deml L, Leicht J, Kramer BK. Validation of T-Track(R) CMV to assess the functionality of cytomegalovirus-reactive cell-mediated immunity in hemodialysis patients. BMC Immunol. 2017 Mar 7;18(1):15. doi: 10.1186/s12865-017-0194-z.
PubMed 28270092
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of Lophius Kits T-Track® CMV and T-Track® EBV to Assess the Functionality of Cell-mediated Immunity (CMI) in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT02630537
- Acronym / sponsor ID
- LB-A1 (UREA-CMV-EBV)
- Conditions
- Renal Failure Chronic Requiring Dialysis
- Keywords
- Cytomegalovirus, Epstein- Barr virus, Cell-mediated immunity, T-Track® CMV, T-Track® EBV, hemodialysis, ELISpot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Lophius Biosciences GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 15 Dec 2015 (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.
Cell-mediated immunity (CMI) and in particular T cells play a critical role in the rejection of transplanted organs. Thus, in transplant recipients a life-long and individualized immunosuppressive medication is required to avoid graft rejection. However, a too weak suppression of CMI causes acute and chronic graft damage leading to transplant loss, whereas a too potent suppression of CMI supports opportunistic infections and reactivation of persistent viruses.
One of the biggest challenges in the field of transplantation is to provide a personalized immunosuppressive and antiviral therapy based on reliable assessment and monitoring of CMI. This could lead to a reduction of graft rejections and virus reactivations in transplant recipients.
With the development of both assays T-Track® CMV and T-Track® EBV, Lophius Biosciences GmbH has implemented its novel proprietary T-activation technology for an improved assessment of the functionality of CMI in cytomegalovirus (CMV)- and/or Epstein-Barr virus (EBV)-seropositive individuals. In contrast to other existing systems the Lophius assays open up the opportunity to characterize the functionality of CMI as an entire network.
The planned clinical multicenter study aims to verify the suitability of the two assays for a reliable assessment of the functionality of CMI.
Hemodialysis patients have been identified as an appropriate patient cohort for investigating the clinical sensitivity of the Lophius assays as these patients closely resemble kidney transplant recipients prior to an immunosuppressive therapy.
The determination of the functional CMI in the course of an immunosuppressive treatment may in future enable physicians to optimize the individual immunosuppressive and antiviral therapy in transplant recipients to reduce the risk of rejection as well as virus reactivations and associated diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient being hemodialysis-dependent due to end-stage kidney disease
Key inclusion criteria (3 listed)
- Patient being hemodialysis-dependent due to end-stage kidney disease
- Male or female patient at least 18 years of age
- Written informed consent
Key exclusion criteria (5 listed)
- Patient requires ongoing dosing with a systemic immunosuppressive drug
- Patient has received immunosuppressive therapy within the last three month
- Patient is known to be positive for HIV or suffering from chronic hepatitis infections
- Patient has significant uncontrolled concomitant infections or other unstable medical conditions that could interfere with the study objectives
- Patient has any form of substance abuse, psychiatric disorder or condition that, in the opinion of the investigator may invalidate communication with the investigator
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
Percentage of CMV or EBV seropositive hemodialysis patients showing significant numbers of functional CMV or EBV-protein-reactive blood leucocytes applying T-Track® CMV or T-Track® EBV
Time frame: 1 day
Determination of the clinical sensitivity of T-Track® CMV and T-Track® EBV. T-Track® assays are based on the stimulation of peripheral blood mononuclear cells (PBMC) with preselected immunodominant T-activated proteins derived from the human Cytomegalovirus (CMV) and the Epstein-Barr-Virus (EBV) and the subsequent quantification of IFN-gamma producing blood leucocytes (Lophius biomarker for assessing the functionality of CMI) applying ELISpot technology.
1 secondary outcome
Percentage of CMV or EBV seropositive hemodialysis patients showing significant numbers of functional CMV or EBV-protein-reactive blood leucocytes applying EBV and CMV peptide-loaded Pro5® Pentamers and the Quantiferon® CMV assay
Time frame: 1 day
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 15 Dec 2015.
- Derived from this study: PubMed 28270092Banas B, Boger CA, Luckhoff G, Kruger B, Barabas S, Batzilla J, Schemmerer M, Kostler J, Bendfeldt H, Rascle A, Wagner R, Deml L, Leicht J, Kramer BK. Validation of T-Track(R) CMV to assess the functionality of cytomegalovirus-reactive cell-mediated immunity in hemodialysis patients. BMC Immunol. 2017 Mar 7;18(1):15. doi: 10.1186/s12865-017-0194-z.
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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.
Bernhard Banas, Prof. principal investigator
University Hospital Regensburg
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Failure Chronic Requiring Dialysis, run by Lophius Biosciences GmbH.
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 5 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 15 Dec 2015. 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?
Percentage of CMV or EBV seropositive hemodialysis patients showing significant numbers of functional CMV or EBV-protein-reactive blood leucocytes applying T-Track® CMV or T-Track® EBV (time frame: 1 day). 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 NCT02630537, 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 15 Dec 2015.