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A Study That Will Look at the Impact of Immunosuppression on Antibody Production in Kidney Transplant Recipients.

NCT ID: NCT00275717

Last Updated: 2010-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2010-12-31

Brief Summary

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This study is being done to collect blood and bone marrow samples for biologic studies of antibody producing cells. Donor specific antibodies can cause damage to the kidneys after they are transplanted. The study will look at the impact of immunosuppression on antibody production by antibody producing cells.

Detailed Description

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Bone marrow and blood samples from both non-sensitized kidney transplant recipients and sensitized kidney transplant recipients will be collected. The samples will be used to compare the effect immunosuppression has on the antibody producing cells from both of these kinds of transplant recipients. Bone marrow will be collected from sensitized kidney transplant recipients before desensitization therapy prior to transplantation and at the time of kidney transplant surgery. Non-sensitized patients will have bone marrow collected only at the time of kidney transplant surgery. Blood will be collected at the same time point that the marrow is collected in both kinds of patients.

Conditions

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Kidney Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Participants must be between the ages of 18 and 70 years of age and undergoing a kidney transplant.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Principal Investigators

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Mark D. Stegall, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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374-05

Identifier Type: -

Identifier Source: org_study_id