Desensitization Protocol for Deceased Donor List

Completed

Conditions studied: Transplant; Failure, Kidney

In brief

Purpose of the study: The specific aims of this study are to evaluate overall efficacy and safety of the pre-transplant IVIG treatment in our transplant center since 2007 and to identify factors affecting treatment outcomes in order to improve patient selection and treatment protocols for future patients.

Key facts

Study ID

NCT01642225

Run by

University of Miami

People needed

180

Starts

2012-06-01

Expected to finish

2014-06-01

Last updated by the study team

2014-10-20

Who can join

Age: 7 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Recent (< 3 months) high levels of anti-HLA antibodies (at least one cPRA ≥ 40%).
• Waiting time greater than 1 year for blood type AB, 2 years for blood types A, B, or O.

You may not qualify if…

• Female subject is pregnant or lactating.
• Subject has an uncontrolled concomitant infection or any other unstable medical condition (e.g., uncontrolled cardiovascular disease) that could interfere with the study objectives.
• Subject has an uncontrolled active hepatitis B, hepatitis C, or HIV infection.
• Subject has a current malignancy or a recent history of any malignancy that is deemed to be contraindicated to kidney transplantation.
• Subject has a psychiatric illness that, in the judgment of caring physicians, may interfere with study participation.

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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