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

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00275717
First received: January 10, 2006
Last updated: December 20, 2010
Last verified: December 2010
  Purpose

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 Phase
Kidney Transplant
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects of Thymoglobulin on Antibody Screening Cells.

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Enrollment: 60
Study Start Date: March 2005
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275717

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

No publications provided

Responsible Party: Mark D. Stegall, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00275717     History of Changes
Other Study ID Numbers: 374-05
Study First Received: January 10, 2006
Last Updated: December 20, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014