XM-One Study for Living Donor Program
Donor-Specific Antibody (DSA) (HLA) levels and non-HLA antibody levels in recipients prior to living kidney transplantation and randomize these individuals into a desensitization protocol in order to evaluate shifts that can occur with the Luminex and XM-One assay after treatment and up to 6 months post transplant.
If desensitization is needed prior to transplantation in individuals with a negative crossmatch but positive DSA and/or XM-one - patients will be evaluated clinically with routine lab tests (serum creatinine levels, spot urine protein and spot urine creatinine levels) as well as protocol biopsy evaluations.
Transplant; Failure, Kidney
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||XM-One Study for Living Donor Program|
A total of 6 teaspoons of blood will be drawn.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
- Rates of acute rejection including subclinical rejection - acute T cell mediated (cellular) rejection, antibody mediated acute rejection, and chronic antibody-associated injury (i.e.: Transplant Glomerulopathy, Chronic allograft arteriopathy) between the groups.
- Evaluation of endothelial cell activation and injury on biopsies by checking markers for endothelial cell activation and injury (intercellular adhesion molecule-1, ICAM-1/CD54; vascular cell adhesion molecule-1, VCAM-1/CD106; and E-selectin, ELAM-1/CD62E) in two-color stains of tissue with classical endothelial markers (CD34 and Factor VIII).
- Measurement of serum/plasma levels of TNF-alpha and VEGF and decreased levels of protein C and protein S in the circulation, as an assessment of graft vascular perturbation.
- Circulating Endothelial Cells (CECs) will be measured by flow cytometry with markers for endothelial cell activation.
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33186|
|Contact: Lois Hanson, R.N. 305-355-5315 firstname.lastname@example.org|
|Principal Investigator: Giselle Guerra, M.D.|
|Principal Investigator:||Giselle Guerra, R.N.||University of Miami|