XM-One Study for Living Donor Program

Stopped early

Conditions studied: Transplant; Failure, Kidney

In brief

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.

Key facts

Study ID

NCT01679184

Run by

University of Miami

People needed

4

Starts

2013-06-01

Expected to finish

2015-09-01

Last updated by the study team

2015-11-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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