NCT00788021

Completed

Protective Immunity Project 01

Emory University Source

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Other study identifiers

Sponsor study identifier

IRB00000709

Secondary identifiers

PIP-01

OTHER · Other

Study Type

observational

Actual enrollment (reported)

124

Locations

1 country

Sites

1

Timeline

Study Start

September 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2011

Actual (reported)

Study Completion

October 2011

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 124 participants
Study completion date: October 2011
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2006
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
November 7, 2008
Actual (reported)
First Posted
November 10, 2008
Actual (reported)
Primary Completion
January 2011
Actual (reported)
Study Completion
October 2011
Actual (reported)

Last Updated: November 25, 2013
Status Verified: November 2013
Last Update Submitted: November 21, 2013

Conditions

Immunity Immunosuppression Kidney Transplantation

Keywords

TransplantImmunityImmunosuppression

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

Age18 Years - 59 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

Sampling MethodNon-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

Sponsors & Collaborators

Emory University
Otherlead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

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

Enrollment

124 participants (actual enrollment reported by the registry).

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 2006

Date type not reported

This date has not been verified as actual or estimated.

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Phase 4Unknown

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Completed

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HLA-Identical Sibling Renal Transplant Tolerance

Not ApplicableCompleted

NCT00240994

Safety in Immunomodulatory Functions of Alemtuzumab (Campath) in Pediatric Kidney Transplantation Recipients

Phase 2Completed

NCT01733056

Immune Response to Vaccination in Patients Receiving Single Drug Immunosuppression

Not ApplicableCompleted

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). -

Contact the study team to confirm eligibility.

Primary Completion

January 2011

Actual (reported)

Study Completion

October 2011

Actual (reported)

Last Updated

November 25, 2013

Record last verified: 2013-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00788021
Data provider: ClinicalTrials.gov
Source updated: 2013-11-25
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:43 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (3)

Tacrolimus

Sirolimus

Healthy controls

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations