CytomegalovirusCMValueNCT02083042
Clinical Validation of Lophius Biosciences Kit T-Track® CMV in Kidney Transplant Recipients
An observational study of Cytomegalovirus and Kidney Transplantation, run by Lophius Biosciences GmbH at 1 site in Germany.
Trial summary
This study aims to validate whether Lophius Biosciences Kit T-Track® CMV is suitable to assess the functionality of CMV-specific cell-mediated immunity (CMI) and to determine a protective cut-off value for CMV reactivations/disease in kidney transplant recipients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cytomegalovirus, Kidney Transplantation, CMV Specific Immune Response
- How many people
- 97 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2013to Dec 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Kidney transplant recipients of intermediate risk groups for CMV serostatus (D+/R+; D-/R+), and scheduled for the preemptive antiviral strategy
Who may be able to join
- Patient receiving a kidney graft
- Recipient being CMV-seropositive prior transplantation and receiving a graft from either a CMV-seropositive or from a seronegative donor (intermediate risk groups, D+/R+; D-/R+,)
- Patient scheduled to follow the preemptive antiviral strategy with oral valganciclovir or intravenous ganciclovir after transplantation
- Patient receiving the standard triple immunosuppressive regimen (CNI, MMF/MPA or mTOR inhibitors, steroids), with or without induction therapy (except ATG) as start therapy after transplantation
- Male or female patient at least 18 years of age
- Written informed consent
Who cannot join
- Patient is scheduled for the optional visit 1, but requires ongoing treatment with a systemic immunosuppressive drug already prior to kidney transplantation (except induction therapy other than ATG)
- Patient receiving ATG as induction therapy
- 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 before transplantation that could interfere with the study objectives
- Patient is unable to comply with the visit schedule in the protocol
- Patient has any form of substance abuse, psychiatric disorder or condition that, in the opinion of the investigator may invalidate communication with the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Validation of Lophius Biosciences Kit T-Track® CMV to Assess the Functionality of CMV-specific Cell-mediated Immunity (CMI) and Its Suitability to Determine a Protective Cut-off Value for CMV Reactivations/Disease in Kidney Transplant Recipients
This study aims to validate whether Lophius Biosciences Kit T-Track® CMV is suitable to assess the functionality of CMV-specific cell-mediated immunity (CMI) and to determine a protective cut-off value for CMV reactivations/disease in kidney transplant recipients.
Lophius kit T-Track® CMV represents a highly standardized and sensitive diagnostic tool to assess the functionality of a network of clinically relevant CMV-reactive effector cells. It is based on the stimulation of peripheral blood mononuclear cells (PBMC) with urea-formulated immunodominant CMV proteins, pp65 and IE-1, and the subsequent quantification of CMV-specific CMI (spot forming colonies) using a highly sensitive IFN-γ ELISpot.
Read the detailed description
Severe clinical complications including acute rejection and opportunistic infections in solid organ transplantation (SOT) are mainly caused by inadequate impairment of cell-mediated immunity (CMI) by immunosuppressive therapy. In particular CMV is responsible for increased morbidity and mortality revealing the need for either prophylactic or preemptive antiviral treatment. Recipients with negative CMV serology (R-) receiving a graft from a seropositive donor (D+) are at highest risk of developing CMV-associated complications. Therefore, these patients usually receive antiviral prophylaxis whereas patients at intermediate risk (D+/R+ or D-/R+) are treated either prophylactically or preemptively. Although prophylaxis is efficient, it is also accompanied by harmful side effects and high costs. Thus, there is a need for a personalized antiviral as well as immunosuppressive therapy to optimally treat the patient and to improve long-term patient and graft survival. The detection of a protective threshold of functional CMV-reactive cells may help to predict the onset of viral complications, thereby minimizing harmful side effects. Currently available tools to measure CMV-specific cellular immunity reveal striking limitations including a lack of standardization necessitating a commercially available standardized test system. The Lophius kit T-Track® CMV represents a highly standardized and sensitive diagnostic tool to assess the functionality of a network of clinically relevant CMV-reactive effector cells. It is based on the stimulation of peripheral blood mononuclear cells (PBMC) with urea-formulated immunodominant CMV proteins, pp65 and IE-1, and the subsequent quantification of CMV-specific CMI (spot forming colonies) using a highly sensitive IFN-γ ELISpot. This study aims to assess the suitability of the Lophius Biosciences kit T-Track® CMV to determine the CMV-specific CMI in renal transplant recipients scheduled for a preemptive antiviral treatment strategy. Furthermore, it will be investigated if the results obtained with T-Track® CMV are suitable to define a cut-off value of CMV-specific CMI mediating protection from CMV reactivations and related complications. Moreover, possible associations between CMV-specific CMI measured with T-Track® CMV and clinical complications including acute rejection episodes and opportunistic infections will be analyzed as well as the influence of the immunosuppressive treatment and the patient's HLA type on viral immunity.
- Keywords
- CMV, T-Track CMV, kidney transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of changes in pp65 and/or IE-1 specific CMI applying T-Track® CMV
Measured: before Tx, week 3,6,9,12,15,18 and 21 after Tx and unscheduled visits in case of suspicion of CMV related complications; individual observation period 6 months
Secondary outcomes (1)
Changes in CMV viral load measured by CMV-PCR or pp65 antigenemia test
Measured: week 3,6,9,12,15,18,21 after Tx and in case of CMV complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startAug 2013
- Primary completionOct 2015
- Study completionDec 2015
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 CytomegalovirusStudies 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
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lophius Biosciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083042
- Sponsor's protocol ID
- LB-A2(Urea-CMV)
- Acronym
- CMValue
- Status last verified
- Feb 2016
- First submitted
- 23 Feb 2014
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Banas B, Steubl D, Renders L, Chittka D, Banas MC, Wekerle T, Koch M, Witzke O, Muhlfeld A, Sommerer C, Habicht A, Hugo C, Hunig T, Lindemann M, Schmidt T, Rascle A, Barabas S, Deml L, Wagner R, Kramer BK, Kruger B. Clinical validation of a novel enzyme-linked immunosorbent spot assay-based in vitro diagnostic assay to monitor cytomegalovirus-specific cell-mediated immunity in kidney transplant recipients: a multicenter, longitudinal, prospective, observational study. Transpl Int. 2018 Apr;31(4):436-450. doi: 10.1111/tri.13110. Epub 2018 Jan 16.
PubMed 29284181
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of Lophius Biosciences Kit T-Track® CMV to Assess the Functionality of CMV-specific Cell-mediated Immunity (CMI) and Its Suitability to Determine a Protective Cut-off Value for CMV Reactivations/Disease in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT02083042
- Acronym / sponsor ID
- CMValue / LB-A2(Urea-CMV)
- Keywords
- CMV, T-Track CMV, kidney transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Lophius Biosciences GmbHIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Mar 2014 (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.
This study aims to validate whether Lophius Biosciences Kit T-Track® CMV is suitable to assess the functionality of CMV-specific cell-mediated immunity (CMI) and to determine a protective cut-off value for CMV reactivations/disease in kidney transplant recipients.
Lophius kit T-Track® CMV represents a highly standardized and sensitive diagnostic tool to assess the functionality of a network of clinically relevant CMV-reactive effector cells. It is based on the stimulation of peripheral blood mononuclear cells (PBMC) with urea-formulated immunodominant CMV proteins, pp65 and IE-1, and the subsequent quantification of CMV-specific CMI (spot forming colonies) using a highly sensitive IFN-γ ELISpot.
Detailed description
Severe clinical complications including acute rejection and opportunistic infections in solid organ transplantation (SOT) are mainly caused by inadequate impairment of cell-mediated immunity (CMI) by immunosuppressive therapy. In particular CMV is responsible for increased morbidity and mortality revealing the need for either prophylactic or preemptive antiviral treatment. Recipients with negative CMV serology (R-) receiving a graft from a seropositive donor (D+) are at highest risk of developing CMV-associated complications. Therefore, these patients usually receive antiviral prophylaxis whereas patients at intermediate risk (D+/R+ or D-/R+) are treated either prophylactically or preemptively. Although prophylaxis is efficient, it is also accompanied by harmful side effects and high costs. Thus, there is a need for a personalized antiviral as well as immunosuppressive therapy to optimally treat the patient and to improve long-term patient and graft survival. The detection of a protective threshold of functional CMV-reactive cells may help to predict the onset of viral complications, thereby minimizing harmful side effects. Currently available tools to measure CMV-specific cellular immunity reveal striking limitations including a lack of standardization necessitating a commercially available standardized test system. The Lophius kit T-Track® CMV represents a highly standardized and sensitive diagnostic tool to assess the functionality of a network of clinically relevant CMV-reactive effector cells. It is based on the stimulation of peripheral blood mononuclear cells (PBMC) with urea-formulated immunodominant CMV proteins, pp65 and IE-1, and the subsequent quantification of CMV-specific CMI (spot forming colonies) using a highly sensitive IFN-γ ELISpot. This study aims to assess the suitability of the Lophius Biosciences kit T-Track® CMV to determine the CMV-specific CMI in renal transplant recipients scheduled for a preemptive antiviral treatment strategy. Furthermore, it will be investigated if the results obtained with T-Track® CMV are suitable to define a cut-off value of CMV-specific CMI mediating protection from CMV reactivations and related complications. Moreover, possible associations between CMV-specific CMI measured with T-Track® CMV and clinical complications including acute rejection episodes and opportunistic infections will be analyzed as well as the influence of the immunosuppressive treatment and the patient's HLA type on viral immunity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Kidney transplant recipients of intermediate risk groups for CMV serostatus (D+/R+; D-/R+), and scheduled for the preemptive antiviral strategy
Key inclusion criteria (6 listed)
- Patient receiving a kidney graft
- Recipient being CMV-seropositive prior transplantation and receiving a graft from either a CMV-seropositive or from a seronegative donor (intermediate risk groups, D+/R+; D-/R+,)
- Patient scheduled to follow the preemptive antiviral strategy with oral valganciclovir or intravenous ganciclovir after transplantation
- Patient receiving the standard triple immunosuppressive regimen (CNI, MMF/MPA or mTOR inhibitors, steroids), with or without induction therapy (except ATG) as start therapy after transplantation
- Male or female patient at least 18 years of age
Key exclusion criteria (6 listed)
- Patient is scheduled for the optional visit 1, but requires ongoing treatment with a systemic immunosuppressive drug already prior to kidney transplantation (except induction therapy other than ATG)
- Patient receiving ATG as induction therapy
- 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 before transplantation that could interfere with the study objectives
- Patient is unable to comply with the visit schedule in the protocol
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
Determination of changes in pp65 and/or IE-1 specific CMI applying T-Track® CMV
Time frame: before Tx, week 3,6,9,12,15,18 and 21 after Tx and unscheduled visits in case of suspicion of CMV related complications; individual observation period 6 months
1 secondary outcome
Changes in CMV viral load measured by CMV-PCR or pp65 antigenemia test
Time frame: week 3,6,9,12,15,18,21 after Tx and in case of CMV complications
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 8 Feb 2016.
- Derived from this study: PubMed 29284181Banas B, Steubl D, Renders L, Chittka D, Banas MC, Wekerle T, Koch M, Witzke O, Muhlfeld A, Sommerer C, Habicht A, Hugo C, Hunig T, Lindemann M, Schmidt T, Rascle A, Barabas S, Deml L, Wagner R, Kramer BK, Kruger B. Clinical validation of a novel enzyme-linked immunosorbent spot assay-based in vitro diagnostic assay to monitor cytomegalovirus-specific cell-mediated immunity in kidney transplant recipients: a multicenter, longitudinal, prospective, observational study. Transpl Int. 2018 Apr;31(4):436-450. doi: 10.1111/tri.13110. Epub 2018 Jan 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cytomegalovirus and Kidney Transplantation, run by Lophius Biosciences GmbH at 1 site in Germany.
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 6 inclusion and 6 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 8 Feb 2016. 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 Germany. 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?
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?
Determination of changes in pp65 and/or IE-1 specific CMI applying T-Track® CMV (time frame: before Tx, week 3,6,9,12,15,18 and 21 after Tx and unscheduled visits in case of suspicion of CMV related complications; individual observation period 6 months). 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 NCT02083042, 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 8 Feb 2016.