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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00275717
Recruitment Status : Completed
First Posted : January 12, 2006
Last Update Posted : December 22, 2010
Genzyme, a Sanofi Company
Information provided by:
Mayo Clinic

Brief Summary:
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.

Condition or disease
Kidney Transplant

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects of Thymoglobulin on Antibody Screening Cells.
Study Start Date : March 2005
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Three groups will be studied:

  1. Non-sensitized renal allograft candidates prior to any therapy;
  2. High DSA recipients--Recipients with a positive T or B cell cytotoxicity crossmatch or a B cell flow cytometric crossmatch assay with a channel shift >350 at baseline against their living donor at baseline and
  3. Low DSA recipients—recipients with a negative T and B cell cytotoxicity assay, but a positive T or B cell flow cytometric crossmatch with a B cell channel shift <350.
Participants must be between the ages of 18 and 70 years of age and undergoing a kidney transplant.

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 identifier (NCT number): NCT00275717

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Genzyme, a Sanofi Company
Principal Investigator: Mark D. Stegall, M.D. Mayo Clinic

Responsible Party: Mark D. Stegall, MD, Mayo Clinic Identifier: NCT00275717     History of Changes
Other Study ID Numbers: 374-05
First Posted: January 12, 2006    Key Record Dates
Last Update Posted: December 22, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs