Awaiting Organ TransplantViracorCMINCT01558037
Cell Mediated Immunity With Risk of Cytomegalovirus (CMV) in Solid Organ Transplant Recipients
An observational study of Awaiting Organ Transplant and Infection in Solid Organ Transplant Recipients, run by Michael Ison at 1 site in United States.
Trial summary
Cytomegalovirus (CMV) is a common infection with 60-90% of all adults worldwide having evidence of having the infection at sometime in their life. Patients who have undergone transplantation are at risk at developing CMV, especially those patients who do not have antibodies to CMV pre-transplant, but received an organ… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Awaiting Organ Transplant, Infection in Solid Organ Transplant Recipients
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Mar 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: The main study will recruit adult solid organ transplant recipients at Northwestern Memorial Hospital who are CMV donor positive, recipient negative (D+/R-) and SOT recipients at NMH who are CMV recipient positive, irrespective of donor status (D±/R+). A sub-study of this study will enroll up to 50 adult SOT recipients who have quantifiable CMV DNA by PCR and require CMV antiviral therapy, irrespective of their participation in the main study. Patients will be identified prior to transplantation as part of the pre-transplant evaluation process and will be consented either pre-transplant or on the first post-operative day in which they can provide written consent.
Who may be able to join
- Main Study Subjects will be recruited if they are listed for a SOT (liver, liver-kidney, kidney, kidney-pancreas, cardiac). At the time of transplant, consented patients will have an immediate pre-transplant blood draw for baseline labs subsequent labs will only be drawn if the donor/recipient CMV serostatus is CMV D+/R- (up to a maximum of 50 subjects) or D+/R+ or D-/R+ (up to a maximum of 50 subjects). Subjects must be ≥ 18 years of age, be consentable, and agree to have laboratory and clinical follow-up at Northwestern.
- CMV Replication Substudy
- Subjects will be recruited if they have undergone SOT, are found to have a positive CMV QnPCR (> 600 copies/mL) and will be subsequently treated for CMV infection with either intravenous ganciclovir or oral valganciclovir therapy at the discretion of the treating provider. Subjects must be ≥ 18 years of age, able to give consent, and agree to have laboratory and clinical follow-up at Northwestern.
Who cannot join
- Subjects will be excluded if they have had a previous history of CMV infection after SOT prior to enrollment (a prior episode of CMV infection or replication prior to the onset of the current episode). Subjects will also be excluded if the subject cannot give informed consent or if the subject is not able to comply with follow-up testing and/or treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: A Study to Correlate CMV-Specific Cell Mediated Immunity With Risk of CMV Disease and With Clinical Response to Therapy Following Solid Organ Transplantation
Cytomegalovirus (CMV) is a common infection with 60-90% of all adults worldwide having evidence of having the infection at sometime in their life. Patients who have undergone transplantation are at risk at developing CMV, especially those patients who do not have antibodies to CMV pre-transplant, but received an organ from a recipient who has antibodies to CMV. Usually the disease CMV causes is mild and sometimes patients are not even aware they have the infection without tests to detect the virus. CMV can less commonly cause serious infections that affect many parts of the body including the intestines, liver, or lungs. In rare cases CMV infection in transplant patients can cause death.
All patients who receive a transplant are monitored for CMV infection. The purpose of this study is to determine if there is a way the investigators can determine in advance which patients are at greatest risk of CMV infection. Specifically, this study will analyze the immune system of transplant patients to determine if there are specific elements of the immune system that 1) helps protect the body against CMV infection, and 2) helps the body combat CMV once it is infected. Identifying these specific elements of the immune system could improve the physician's ability to monitor the SOT patients for CMV infection, and to help treat CMV in those patients that become infected.
Read the detailed description
Our hypothesis is that the degree of CMV cell-mediated immune (CMI) response correlates inversely with the risk of development of CMV replication and correlates with the response to initial therapy and risk of relapse after onset of replication. The primary aim of this study is to determine an association between CMV CMI response and both the risk of CMV infection and the degree of initial CMV viremia and rate of viremia clearance with standard CMV therapy. The first secondary aim is to determine an association between CMV QnPCR, CMV microRNA expression, TLR2 expression, and CMV-specific CMI and the risk of relapse of CMV disease after initial treatment. The second secondary aim is to determine an association between CMV QnPCR, CMV microRNA expression, TLR2 expression, and CMV-specific CMI collected at CMV infection and the following prospective data: Development of CMV end organ disease, resolution of symptoms of CMV infection, other non-CMV infections after initial CMV infection, graft rejection, recurrent or resistant CMV infection, and other markers of immune function. The third secondary aim is to determine an association between CMV QnPCR, CMV microRNA expression, TLR2 expression, and CMV-specific CMI response collected at CMV infection in solid-organ transplant (SOT) recipients and the following retrospective data: Type of SOT, CMV donor/recipient status, type and degree of immunosuppression, type and length of CMV prophylaxis, prior graft rejection and infections (non-CMV).
- Keywords
- transplant, solid organ transplant, kidney transplant, liver transplant, pancreas transplant, heart transplant, CMV, Cytomegalovirus
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 |
|---|---|---|
| Main study | Main study patients are enrolled before or at time of solid organ transplant. Qualifying subjects either have tested positive for Cytomegalovirus or have a donor who has tested positive for Cytomegalovirus. | |
| Sub study | Subjects are enrolled to this arm who have begun replicating Cytomegalovirus post transplant. These subjects may or may not have been on the main study arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of CMV Cell-Mediated Immune Response
Association between CMV CMI response and both the risk of CMV infection and the degree of initial CMV viremia and rate of viremia clearance with standard CMV therapy
Measured: For 8 months after transplant or 4 months after clearance of CMV
Secondary outcomes (1)
Assessment of CMV QnPCR, CMV microRNA expression, TLR2 expression, and CMV-specific CMI
Association between CMV QnPCR, CMV microRNA expression, TLR2 expression, and CMV-specific CMI collected at CMV infection and the following prospective data:
- Development of CMV end organ disease
- Resolution of symptoms of CMV infection
- Other non-CMV infections after initial CMV infection
- Graft rejection
- Recurrent or resistant CMV infection
- Other markers of immune function
- Type of SOT
- CMV donor/recipient status
- Type and degree of immunosuppression
- Type and length of CMV prophylaxis
- Prior graft rejection and infections (non-CMV)
Measured: For 8 months after transplant or 4 months after clearance of CMV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startApr 2010
- Primary completionDec 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Awaiting Organ TransplantStudies 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
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Ison
- Sponsor type
- University, hospital or other
- Collaborators
- ViraCor Laboratories
- Responsible party
- Sponsor-investigator, Michael Ison, Northwestern University
- Investigators
- Michael G Ison, MD,MS, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558037
- Sponsor's protocol ID
- NU-ViraCor 001
- Acronym
- ViracorCMI
- Status last verified
- Apr 2013
- First submitted
- 14 Mar 2012
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Correlate CMV-Specific Cell Mediated Immunity With Risk of CMV Disease and With Clinical Response to Therapy Following Solid Organ Transplantation
- ClinicalTrials.gov ID
- NCT01558037
- Acronym / sponsor ID
- ViracorCMI / NU-ViraCor 001
- Keywords
- transplant, solid organ transplant, kidney transplant, liver transplant, pancreas transplant, heart transplant, CMV, Cytomegalovirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Michael IsonUniversity, hospital or other
- Collaborators
- ViraCor Laboratories
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 20 Mar 2012 (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.
Cytomegalovirus (CMV) is a common infection with 60-90% of all adults worldwide having evidence of having the infection at sometime in their life. Patients who have undergone transplantation are at risk at developing CMV, especially those patients who do not have antibodies to CMV pre-transplant, but received an organ from a recipient who has antibodies to CMV. Usually the disease CMV causes is mild and sometimes patients are not even aware they have the infection without tests to detect the virus. CMV can less commonly cause serious infections that affect many parts of the body including the intestines, liver, or lungs. In rare cases CMV infection in transplant patients can cause death.
All patients who receive a transplant are monitored for CMV infection. The purpose of this study is to determine if there is a way the investigators can determine in advance which patients are at greatest risk of CMV infection. Specifically, this study will analyze the immune system of transplant patients to determine if there are specific elements of the immune system that 1) helps protect the body against CMV infection, and 2) helps the body combat CMV once it is infected. Identifying these specific elements of the immune system could improve the physician's ability to monitor the SOT patients for CMV infection, and to help treat CMV in those patients that become infected.
Detailed description
Our hypothesis is that the degree of CMV cell-mediated immune (CMI) response correlates inversely with the risk of development of CMV replication and correlates with the response to initial therapy and risk of relapse after onset of replication. The primary aim of this study is to determine an association between CMV CMI response and both the risk of CMV infection and the degree of initial CMV viremia and rate of viremia clearance with standard CMV therapy. The first secondary aim is to determine an association between CMV QnPCR, CMV microRNA expression, TLR2 expression, and CMV-specific CMI and the risk of relapse of CMV disease after initial treatment. The second secondary aim is to determine an association between CMV QnPCR, CMV microRNA expression, TLR2 expression, and CMV-specific CMI collected at CMV infection and the following prospective data: Development of CMV end organ disease, resolution of symptoms of CMV infection, other non-CMV infections after initial CMV infection, graft rejection, recurrent or resistant CMV infection, and other markers of immune function. The third secondary aim is to determine an association between CMV QnPCR, CMV microRNA expression, TLR2 expression, and CMV-specific CMI response collected at CMV infection in solid-organ transplant (SOT) recipients and the following retrospective data: Type of SOT, CMV donor/recipient status, type and degree of immunosuppression, type and length of CMV prophylaxis, prior graft rejection and infections (non-CMV).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main study | – | –Main study patients are enrolled before or at time of solid organ transplant. Qualifying subjects either have tested positive for Cytomegalovirus or have a donor who has tested positive for Cytomegalovirus. |
| Sub study | – | –Subjects are enrolled to this arm who have begun replicating Cytomegalovirus post transplant. These subjects may or may not have been on the main study arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The main study will recruit adult solid organ transplant recipients at Northwestern Memorial Hospital who are CMV donor positive, recipient negative (D+/R-) and SOT recipients at NMH who are CMV recipient positive, irrespective of donor status (D±/R+). A sub-study of this study will enroll up to 50 adult SOT recipients who have quantifiable CMV DNA by PCR and require CMV antiviral therapy, irrespective of their participation in the main study. Patients will be identified prior to transplantation as part of the pre-transplant evaluation process and will be consented either pre-transplant or on the first post-operative day in which they can provide written consent.
Key inclusion criteria (3 listed)
- Main Study Subjects will be recruited if they are listed for a SOT (liver, liver-kidney, kidney, kidney-pancreas, cardiac). At the time of transplant, consented patients will have an immediate pre-transplant blood draw for baseline labs subsequent labs will only be drawn if the donor/recipient CMV serostatus is CMV D+/R- (up to a maximum of 50 subjects) or D+/R+ or D-/R+ (up to a maximum of 50 subjects). Subjects must be ≥ 18 years of age, be consentable, and agree to have laboratory and clinical follow-up at Northwestern.
- CMV Replication Substudy
- Subjects will be recruited if they have undergone SOT, are found to have a positive CMV QnPCR (> 600 copies/mL) and will be subsequently treated for CMV infection with either intravenous ganciclovir or oral valganciclovir therapy at the discretion of the treating provider. Subjects must be ≥ 18 years of age, able to give consent, and agree to have laboratory and clinical follow-up at Northwestern.
Key exclusion criteria (1 listed)
- Subjects will be excluded if they have had a previous history of CMV infection after SOT prior to enrollment (a prior episode of CMV infection or replication prior to the onset of the current episode). Subjects will also be excluded if the subject cannot give informed consent or if the subject is not able to comply with follow-up testing and/or treatment.
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
Assessment of CMV Cell-Mediated Immune Response
Time frame: For 8 months after transplant or 4 months after clearance of CMV
Association between CMV CMI response and both the risk of CMV infection and the degree of initial CMV viremia and rate of viremia clearance with standard CMV therapy
1 secondary outcome
Assessment of CMV QnPCR, CMV microRNA expression, TLR2 expression, and CMV-specific CMI
Time frame: For 8 months after transplant or 4 months after clearance of CMV
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 5 Apr 2013.
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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.
Michael G Ison, MD,MS principal investigator
Northwestern University
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 Awaiting Organ Transplant and Infection in Solid Organ Transplant Recipients, run by Michael Ison at 1 site in United States.
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 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: finished, as of the sponsor's last update on 5 Apr 2013. 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 United States. 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?
Assessment of CMV Cell-Mediated Immune Response (time frame: For 8 months after transplant or 4 months after clearance of CMV). 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 2013.