CMV Viral Loads in Seropositive Renal Transplant RecipientsNCT02061215
Study of CMV in Kidney Transplant Recipients
An observational study of CMV Viral Loads in Seropositive Renal Transplant Recipients, run by University of Nebraska at 1 site in United States.
Trial summary
Using novel CYTOF technology to measure a wide array of innate and adaptive cell proportions and cytokine levels, we plan a pilot study in old (>/=60 years) and young (20-40 years) renal transplant recipients who are cytomegalovirus (CMV) seropositive (regardless of donor serology). Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- CMV Viral Loads in Seropositive Renal Transplant Recipients
- What is being tested?
- CMV viral load
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 14 Jul 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recipients of renal transplants at the University of Nebraska Medical Center
Who may be able to join
- Adults young age 20-40 years and old >/= 60 years
- Anticipate renal transplant within 2 weeks
- CMV sero-positive renal transplant recipients
- HLA type of A1, A2, B7 of recipient
Who cannot join
- Pediatric recipients
- Multi-organ transplant recipients
- Highly sensitized (antigen level) recipients
- Prior organ transplant recipients
- Patients who do not wish to participate in study, or who cannot consent to research
- Patients with active CMV infection
- Seronegative
- HLA Type of organ recipient not corresponding to A1,A2, B7
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Effects of Age on Immune Risk Profile in CMV Seropositive Kidney Transplant Recipients After Release From CMV Prophylaxis
Using novel CYTOF technology to measure a wide array of innate and adaptive cell proportions and cytokine levels, we plan a pilot study in old (>/=60 years) and young (20-40 years) renal transplant recipients who are cytomegalovirus (CMV) seropositive (regardless of donor serology). Viral load measurements will be performed at baseline prior to transplant (within 1 week),and then at 3, 7 and 10 months after transplant. It is expected that the patient will receive anti-CMV prophylaxis until 6 months post-transplant, so the latter two time points will reflect responses after "release" from antiviral suppression. Each patient will serve as their own control, with comparisons made between measurements at baseline and then at each timepoint. In addition, clinical data will be collected at the time points indicated, particularly renal function and the presence/absence of acute rejection.
Read the detailed description
Using novel CYTOF technology to measure a wide array of innate and adaptive cell proportions and cytokine levels, we plan a pilot study in old (>/=60 years) and young (20-40 years) renal transplant recipients who are CMV seropositive (regardless of donor serology). Viral load measurements will be performed at baseline prior to transplant (within 1 week),and then at 3, 7 and 10 months after transplant. It is expected that the patient will receive anti-CMV prophylaxis until 6 months post-transplant, so the latter two time points will reflect responses after "release" from antiviral suppression. Each patient will serve as their own control, with comparisons made between measurements at baseline and then at each timepoint.
Blood from 10 patients in each age group will be studied, to collect virologic and immune response data:
- CYTOF (broad array of measurements)
- Tetramer assays (requires recipient HLA type of A1, A2, B7)
- CMV viral load PCR
- Response to pneumococcal antigens and inactivated influenza virus
In addition, clinical data will be collected at the time points indicated,particularly renal function and the presence/absence of acute rejection.
- Being tested
- CMV viral load
- Keywords
- CYTOF, CMV, PCR, HLA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMV viral loadOther
| Study group | Role | What they receive |
|---|---|---|
| recipients aged 20-40 | CMV viral load Receives: Other: CMV viral load | |
| recipients older than 60 | CMV viral load Receives: Other: CMV viral load |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMV viral loads in younger seropositive kidney transplant recipients before transplant, during treatment and after therapy
CMV viral loads in younger (age 20-40) seropositive kidney transplant recipients before renal transplant, during treatment with anti-viral therapy, and after release from therapy
Measured: 1 year
CMV viral loads in older seropositive kidney transplant recipients before transplant, during treatment and after therapy
CMV viral loads in older (age >/= 60) seropositive kidney transplant recipients before renal transplant, during treatment with anti-viral therapy, and after release from therapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startApr 2014
- Primary completion14 Jul 2015
- Study completion14 Jul 2015
Why it stopped: PI halted study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMV Viral Loads in Seropositive Renal Transplant RecipientsStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Maskin, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061215
- Sponsor's protocol ID
- 0742-13-EP
- Status last verified
- Oct 2024
- First submitted
- 7 Feb 2014
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Age on Immune Risk Profile in CMV Seropositive Kidney Transplant Recipients After Release From CMV Prophylaxis
- ClinicalTrials.gov ID
- NCT02061215
- Acronym / sponsor ID
- 0742-13-EP
- Keywords
- CYTOF, CMV, PCR, HLA
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI halted study
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 14 Jul 2015 (actual)
- Study completion
- 14 Jul 2015 (actual)
- First posted
- 12 Feb 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.
Using novel CYTOF technology to measure a wide array of innate and adaptive cell proportions and cytokine levels, we plan a pilot study in old (>/=60 years) and young (20-40 years) renal transplant recipients who are cytomegalovirus (CMV) seropositive (regardless of donor serology). Viral load measurements will be performed at baseline prior to transplant (within 1 week),and then at 3, 7 and 10 months after transplant. It is expected that the patient will receive anti-CMV prophylaxis until 6 months post-transplant, so the latter two time points will reflect responses after "release" from antiviral suppression. Each patient will serve as their own control, with comparisons made between measurements at baseline and then at each timepoint. In addition, clinical data will be collected at the time points indicated, particularly renal function and the presence/absence of acute rejection.
Detailed description
Using novel CYTOF technology to measure a wide array of innate and adaptive cell proportions and cytokine levels, we plan a pilot study in old (>/=60 years) and young (20-40 years) renal transplant recipients who are CMV seropositive (regardless of donor serology). Viral load measurements will be performed at baseline prior to transplant (within 1 week),and then at 3, 7 and 10 months after transplant. It is expected that the patient will receive anti-CMV prophylaxis until 6 months post-transplant, so the latter two time points will reflect responses after "release" from antiviral suppression. Each patient will serve as their own control, with comparisons made between measurements at baseline and then at each timepoint.
Blood from 10 patients in each age group will be studied, to collect virologic and immune response data:
- CYTOF (broad array of measurements)
- Tetramer assays (requires recipient HLA type of A1, A2, B7)
- CMV viral load PCR
- Response to pneumococcal antigens and inactivated influenza virus
In addition, clinical data will be collected at the time points indicated,particularly renal function and the presence/absence of acute rejection.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| recipients aged 20-40 | – | Other: CMV viral loadCMV viral load |
| recipients older than 60 | – | Other: CMV viral loadCMV viral load |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recipients of renal transplants at the University of Nebraska Medical Center
Key inclusion criteria (4 listed)
- Adults young age 20-40 years and old >/= 60 years
- Anticipate renal transplant within 2 weeks
- CMV sero-positive renal transplant recipients
- HLA type of A1, A2, B7 of recipient
Key exclusion criteria (8 listed)
- Pediatric recipients
- Multi-organ transplant recipients
- Highly sensitized (antigen level) recipients
- Prior organ transplant recipients
- Patients who do not wish to participate in study, or who cannot consent to research
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 |
|---|---|---|
| CMV viral load | Other | recipients aged 20-40, recipients older than 60 |
Primary outcome
CMV viral loads in younger seropositive kidney transplant recipients before transplant, during treatment and after therapy
Time frame: 1 year
CMV viral loads in younger (age 20-40) seropositive kidney transplant recipients before renal transplant, during treatment with anti-viral therapy, and after release from therapy
CMV viral loads in older seropositive kidney transplant recipients before transplant, during treatment and after therapy
Time frame: 1 year
CMV viral loads in older (age >/= 60) seropositive kidney transplant recipients before renal transplant, during treatment with anti-viral therapy, and after release from therapy
Results and safety
The study was stopped early (reason given: PI halted study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
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.
Alexander Maskin, MD principal investigator
University of Nebraska
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 CMV Viral Loads in Seropositive Renal Transplant Recipients, run by University of Nebraska 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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 17 Oct 2024. 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 was stopped early (reason given: PI halted study). Results are not available in the source record.
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?
CMV viral loads in younger seropositive kidney transplant recipients before transplant, during treatment and after therapy (time frame: 1 year). The study lists 2 primary outcomes in all. 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 17 Oct 2024.