XM-One Study for Living Donor Program

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Miami
Sponsor:
Information provided by (Responsible Party):
Giselle Guerra, University of Miami
ClinicalTrials.gov Identifier:
NCT01679184
First received: August 31, 2012
Last updated: June 22, 2013
Last verified: June 2013
  Purpose

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
Transplant; Failure, Kidney

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: XM-One Study for Living Donor Program

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • DSA [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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:
  • DSA [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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.


Estimated Enrollment: 138
Study Start Date: June 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679184

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33186
Contact: Lois Hanson, R.N.    305-355-5315    lhanson2@med.miami.edu   
Principal Investigator: Giselle Guerra, M.D.         
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Giselle Guerra, R.N. University of Miami
  More Information

No publications provided

Responsible Party: Giselle Guerra, Assistant Professor of Clinical, University of Miami
ClinicalTrials.gov Identifier: NCT01679184     History of Changes
Other Study ID Numbers: XM-One
Study First Received: August 31, 2012
Last Updated: June 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 21, 2014