XM-One Study for Living Donor Program
| Status: | Terminated |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | June 2013 |
| End Date: | September 2015 |
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.
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.
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.
(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.
Inclusion Criteria:
- Recipients receiving deceased donor transplants.
- Living donor transplant that is T-cell flow crossmatch positive.
- HIV, Hepatitis C and B positive patients.
Exclusion Criteria:
- Pregnant women and children will be excluded from the study.
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University of Miami A private research university with more than 15,000 students from around the...
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