A Study That Will Look at the Impact of Immunosuppression on Antibody Production in Kidney Transplant Recipients.
This study has been completed.
Genzyme, a Sanofi Company
Information provided by:
First received: January 10, 2006
Last updated: December 20, 2010
Last verified: December 2010
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.
||Observational Model: Cohort
Time Perspective: Prospective
||The Effects of Thymoglobulin on Antibody Screening Cells.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2010 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Three groups will be studied:
- Non-sensitized renal allograft candidates prior to any therapy;
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00275717
|Rochester, Minnesota, United States, 55905 |
Genzyme, a Sanofi Company
||Mark D. Stegall, M.D.
No publications provided
||Mark D. Stegall, MD, Mayo Clinic
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 10, 2006
||December 20, 2010
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 11, 2013
Physiological Effects of Drugs