Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
97 participants
OBSERVATIONAL
2006-11-30
2011-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Previous research has shown that adult kidney transplant patients are not able to form as much of these protective antibodies as compared to healthy volunteers. Research has also suggested that different immunosuppressive medicines may have different effects on antibody formation. In this study, we hope to evaluate these differences in more detail.
In recent years, increasingly effective, but also increasingly complex, immunosuppressive regimens have been developed, however, there has been little detailed systematic study of the immune changes that occur in response to vaccination with these newer immunosuppressive regimens.Current policies on vaccination of transplant recipients are generic and continue to be based on old concepts rather than on any new understanding of the effects of these newer therapies on the immune system.
We hope to improve our understanding of the effects of the immunosuppressive regimens in use today (calcineurin-inhibitor, or CNI, and sirolimus-based regimens) on immune response to flu vaccine. Such knowledge will be critical to helping clinicians develop strategies for getting desirable immune responses while not causing rejection.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
tacrolimus
Recipients of primary deceased or living donor renal transplant maintained on immunosuppressive regimen utilizing tacrolimus
No interventions assigned to this group
sirolimus
Recipients of primary deceased or living donor renal transplant maintained on immunosuppressive regimen utilizing sirolimus
No interventions assigned to this group
Healthy controls
Age, gender- and race-matched individuals, not on immunosuppressive medications
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Greater than six months post deceased or living donor renal transplant
3. Patients capable of understanding the purposes and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study.
4. Patients with no known contraindications to flu vaccine (e.g. egg allergy, prior serious adverse reaction to flu vaccine, current febrile illness, marked leukopenia (WBC \< 2500 cells/ml)
5. Women of childbearing potential must have a negative serum pregnancy test within 7 days of study enrollment and must not be breast-feeding.
Exclusion Criteria
18 Years
59 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Emory University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Christian P Larsen, MD, PhD
Chairman, Dept. of Surgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christian P. Larsen, MD, DPhil
Role: PRINCIPAL_INVESTIGATOR
Emory University
Kenneth E Kokko, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Emory University
Atlanta, Georgia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PIP-02
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00024793
Identifier Type: -
Identifier Source: org_study_id