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XM-One Study for Living Donor Program

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ClinicalTrials.gov Identifier: NCT01679184
Recruitment Status : Terminated (Lack of staff to enroll patients in this study)
First Posted : September 5, 2012
Last Update Posted : November 13, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease
Transplant; Failure, Kidney

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.

Study Design

Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: XM-One Study for Living Donor Program
Study Start Date : June 2013
Primary Completion Date : September 2015
Study Completion Date : September 2015
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. DSA [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. DSA [ Time Frame: 1 year ]

    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.



Biospecimen Retention:   Samples Without DNA
A total of 6 teaspoons of blood will be drawn.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Living donor kidney transplant recipients
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679184


Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33186
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Giselle Guerra, R.N. University of Miami
More Information

Responsible Party: Giselle Guerra, Assistant Professor of Clinical, University of Miami
ClinicalTrials.gov Identifier: NCT01679184     History of Changes
Other Study ID Numbers: XM-One
First Posted: September 5, 2012    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases