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Protective Immunity Project 01 (PIP-01)

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ClinicalTrials.gov Identifier: NCT00788021
Recruitment Status : Completed
First Posted : November 10, 2008
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Patients who undergo kidney transplant must take medications to prevent organ rejection. There are standard immunosuppressant medications such as prednisone, tacrolimus (Prograf), mycophenolate mofetil(Cellcept) or sirolimus (Rapamune) that are given to patients to prevent rejection. It is well known that patients on immunosuppressant medications are at increased risk from viral infections, such as influenza. However, it is not well understood how immunosuppressive medications may uniquely affect the immune response to infection. This study will determine whether there are unique differences in the effects on the immune system by these different immunosuppressive medications, particularly differences between tacrolimus and sirolimus.

Condition or disease
Kidney Transplantation Immunity Immunosuppression

Detailed Description:
While the benefits of transplantation to society are substantial, the ever-growing population of immunosuppressed recipients poses a unique challenge in development of immunization and containment strategies to protect the population from communicable pathogens and weaponized infectious agents. The immunosuppressive regimens that have allowed the emergence of successful transplant therapy not only inhibit T cell-dependent rejection but also cause systemic immunosuppression, which attenuates the response to vaccines in general and precludes the use of live attenuated vaccines. To date, there has been relatively little detailed systematic study of the immune alterations that accompany either the short- or long-term immunosuppressive regimens used in clinical organ transplantation. Despite the recent development of increasingly effective, but also increasingly complex, regimens using drugs with very distinct molecular targets, current policies on vaccination of transplant recipients are generic and remain based on old concepts rather than on any new understanding of the cellular and molecular effects of these therapies on the human immune system. This proposal seeks to improve our understanding of the biological mechanisms that underlie the distinct immunosuppressive regimens in practice today (calcineurin-inhibitor, or CNI, and sirolimus-based regimens) and in emerging regimens that employ agents with novel mechanisms of action, such as the CD28 costimulation blockers, and/or JAK3 kinase inhibitors. Such knowledge will be critical to strategies for enhancing desirable immune responses while not precipitating rejection.

Study Design

Study Type : Observational
Actual Enrollment : 124 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of the Impact of Chronic Immunosuppressive Regimens on Protective Immunity Over Time in Renal Transplant Recipients
Study Start Date : September 2006
Primary Completion Date : January 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Tacrolimus
Recipients of deceased or living donor renal transplant maintained on immunosuppressive regimen utilizing tacrolimus
Sirolimus
Recipients of deceased or living donor renal transplants maintained on immunosuppressive regimen using sirolimus
Healthy controls
Age, race and gender-matched individuals not on immunosuppressive regimens. Whenever possible an transplant recipient's donor may be recruited to serve as healthy control


Outcome Measures

Primary Outcome Measures :
  1. To determine the effects of chronic immunosuppressive therapies on adaptive immunity [ Time Frame: 2 years ]
  2. To determine the effects of chronic immunosuppressive therapies on innate immunity, dendritic cell phenotype and function and TLR signaling [ Time Frame: 2 years ]
  3. To define the transcriptional signatures associated with specific immunosuppressive regimens [ Time Frame: 2 years ]

Biospecimen Retention:   Samples Without DNA
Whole blood, serum, PBMCs

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing deceased or living donor renal transplant
Criteria

Inclusion Criteria:

  1. Male or female patients between 18 and 59 years of age
  2. 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.
  3. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment and must not be breast-feeding.

Exclusion Criteria:

  1. Patients with any prior organ transplant or multi-organ transplant recipients
  2. Patients that require induction immunosuppression beyond the immunosuppressive regimen proposed in this study. For example, patients that receive anti-lymphocyte antibody therapy or plasmapheresis as a result of pre-formed immunologic reactivity to the transplanted organ.
  3. Patients with evidence of an active systemic infection requiring the continued use of antibiotics, evidence of an HIV infection, or the presence of a chronic active hepatitis B or C.
  4. Patients with history of malignancy in the last 5 years (except successfully treated localized non-melanotic skin cancer)
  5. Patients with severe anemia (hemoglobin < 8 g/dL), leukopenia (WBC < 3000/mm3). -
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00788021


Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Christian P. Larsen, MD, DPhil Emory University
Principal Investigator: Kenneth E. Kokko, MD, PhD Emory University
More Information

Responsible Party: Christian P Larsen, MD, PhD, Chairman, Dept of Surgery, Emory University
ClinicalTrials.gov Identifier: NCT00788021     History of Changes
Other Study ID Numbers: IRB00000709
PIP-01 ( Other Identifier: Other )
First Posted: November 10, 2008    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by Christian P Larsen, MD, PhD, Emory University:
Transplant
Immunity
Immunosuppression

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs