NCT01679184

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 13, 2015

Status Verified

November 1, 2015

Enrollment Period

2.3 years

First QC Date

August 31, 2012

Last Update Submit

November 10, 2015

Conditions

Transplant; Failure, Kidney

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • DSA

    1 year

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Living donor kidney transplant recipients

You may qualify if:

  • Recipients receiving deceased donor transplants.
  • Living donor transplant that is T-cell flow crossmatch positive.
  • HIV, Hepatitis C and B positive patients.

You may not qualify if:

  • Pregnant women and children will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33186, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

A total of 6 teaspoons of blood will be drawn.

Study Officials

  • Giselle Guerra, R.N.

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical

Study Record Dates

First Submitted

August 31, 2012

First Posted

September 5, 2012

Study Start

June 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 13, 2015

Record last verified: 2015-11

Locations

US(1)