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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):
Giselle Guerra, University of Miami

Tracking Information
First Submitted Date August 31, 2012
First Posted Date September 5, 2012
Last Update Posted Date November 13, 2015
Study Start Date June 2013
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 22, 2013)
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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: June 22, 2013)
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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title XM-One Study for Living Donor Program
Official Title XM-One Study for Living Donor Program
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.

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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
A total of 6 teaspoons of blood will be drawn.
Sampling Method Probability Sample
Study Population Living donor kidney transplant recipients
Condition Transplant; Failure, Kidney
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: November 10, 2015)
4
Original Estimated Enrollment
 (submitted: September 4, 2012)
138
Actual Study Completion Date September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01679184
Other Study ID Numbers XM-One
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Giselle Guerra, University of Miami
Study Sponsor University of Miami
Collaborators Not Provided
Investigators
Principal Investigator: Giselle Guerra, R.N. University of Miami
PRS Account University of Miami
Verification Date November 2015