TransplantationNCT00170170
Risk Factors for Cytomegalovirus Disease in Solid Organ Transplantation
An observational study of Transplantation and Infection, run by Mayo Clinic at 1 site in United States.
Trial summary
This study will investigate the clinical variables that may be used to predict who among the solid organ transplant recipients will develop cytomegalovirus (CMV) disease after completing antiviral prophylaxis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplantation, Infection, Cytomegalovirus Infections
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Jun 2007
- 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: Recipients of liver, kidney, pancreas, heart or lung transplantation
Who may be able to join
- Recipients of liver, kidney, pancreas, heart or lung transplantation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Predictors of Late-onset CMV Disease in Solid Organ Transplant Recipients: A Strategy to Improve the Benefits and Reduce the Risks of Anti-CMV Prophylaxis
This study will investigate the clinical variables that may be used to predict who among the solid organ transplant recipients will develop cytomegalovirus (CMV) disease after completing antiviral prophylaxis.
Read the detailed description
This study will investigate the clinical and laboratory variables that may be used to predict who among the solid organ transplant recipients will develop CMV disease after completing antiviral prophylaxis. This is a retrospective study of patients seen at the Mayo Clinic during the past five years.
- Conditions
- Transplantation, Infection, Cytomegalovirus Infections
- Keywords
- cytomegalovirus
- Medical subject headings
- Infections, Cytomegalovirus Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransplantationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Investigators
- Raymund R. Razonable, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170170
- Sponsor's protocol ID
- 2275-04
- Other IDs
- VAL101
- Status last verified
- Feb 2010
- First submitted
- 13 Sep 2005
- Last updated
- 2 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Predictors of Late-onset CMV Disease in Solid Organ Transplant Recipients: A Strategy to Improve the Benefits and Reduce the Risks of Anti-CMV Prophylaxis
- ClinicalTrials.gov ID
- NCT00170170
- Acronym / sponsor ID
- 2275-04
- Conditions
- Transplantation, Infection, Cytomegalovirus Infections
- Keywords
- cytomegalovirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Nov 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 15 Sep 2005 (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 will investigate the clinical variables that may be used to predict who among the solid organ transplant recipients will develop cytomegalovirus (CMV) disease after completing antiviral prophylaxis.
Detailed description
This study will investigate the clinical and laboratory variables that may be used to predict who among the solid organ transplant recipients will develop CMV disease after completing antiviral prophylaxis. This is a retrospective study of patients seen at the Mayo Clinic during the past five years.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recipients of liver, kidney, pancreas, heart or lung transplantation
Key inclusion criteria (1 listed)
- Recipients of liver, kidney, pancreas, heart or lung transplantation
Key exclusion criteria (0 listed)
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
Not reported in the source record.
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 2 Feb 2010.
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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.
Raymund R. Razonable, M.D. principal investigator
Mayo Clinic
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 Transplantation and Infection, run by Mayo Clinic 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 1 inclusion and 0 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 2 Feb 2010. 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.
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 2 Feb 2010.