Protective Immunity Project 01

NCT00788021 | Completed DMC

• 2 other identifiers: IRB00000709PIP-01
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation; Immunity; Immunosuppression

Keywords

Transplant; Immunity; Immunosuppression

Outcome Measures

Primary Outcomes (3)

• To determine the effects of chronic immunosuppressive therapies on adaptive immunity

  2 years

• To determine the effects of chronic immunosuppressive therapies on innate immunity, dendritic cell phenotype and function and TLR signaling

  2 years

• To define the transcriptional signatures associated with specific immunosuppressive regimens

  2 years

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing deceased or living donor renal transplant

You may qualify if:

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

You may not qualify if:

• Patients with any prior organ transplant or multi-organ transplant recipients
• 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.
• 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.
• Patients with history of malignancy in the last 5 years (except successfully treated localized non-melanotic skin cancer)
• Patients with severe anemia (hemoglobin \< 8 g/dL), leukopenia (WBC \< 3000/mm3). -

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, serum, PBMCs

Study Officials

• Christian P. Larsen, MD, DPhil

  Emory University

  PRINCIPAL INVESTIGATOR

• Kenneth E. Kokko, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Dept of Surgery

Study Record Dates

• First Submitted: November 7, 2008
• First Posted: November 10, 2008
• Study Start: September 1, 2006
• Primary Completion: January 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

US (1)