XM-One Study for Living Donor Program

Transplant; Failure, Kidney Clinical Trial

Official title:

XM-One Study for Living Donor Program

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01679184
• Other study ID #: XM-One
• Status: Terminated
• Phase: N/A
• First received: August 31, 2012
• Last updated: November 10, 2015
• Start date: June 2013
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Renal Insufficiency
• Transplant; Failure, Kidney

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DSA	To evaluate Donor-Specific Antibody (DSA) (HLA) levels with Luminex testing and non-HLA antibody levels using XM-One assay in recipients before and after transplantation for up to 6 months as well as in those recipients undergoing desensitization treatment.	1 year	Yes
Secondary	DSA	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.; Determine role of desensitization prior to transplantation in individuals with a negative crossmatch but positive DSA and/or XM-one - based on Luminex and XM-One testing. 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 year	Yes