Trials / Terminated
TerminatedNCT01679184
XM-One Study for Living Donor Program
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 4 (actual)
- Sponsor
- University of Miami · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
1. 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. 2. 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). 3. 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. 4. Circulating Endothelial Cells (CECs) will be measured by flow cytometry with markers for endothelial cell activation.
Conditions
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2015-09-01
- Completion
- 2015-09-01
- First posted
- 2012-09-05
- Last updated
- 2015-11-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01679184. Inclusion in this directory is not an endorsement.