Desensitization Protocol for Deceased Donor List

Completed

• Conditions: Transplant; Failure, Kidney

• Registration Number: NCT01642225
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

Background:

Intravenous immunoglobulin (IVIG) infusion is one of several novel approaches to decrease antibody levels for highly sensitized kidney transplant candidates \[1, 2\]. This approach can potentially give a chance of kidney transplantation to end-stage renal failure patients who could never receive transplantation because of high levels of antibodies and persistent positive crossmatches to all potential kidney donors. Many transplant centers have used this strategy in order to increase transplant rates of highly sensitized patients with various levels of anti-HLA antibodies. However, the responses to the treatment seem to be different in each patient and factors affecting treatment outcome have yet to be determined.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-07-12
• Study First Posted: 2012-07-17
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-17
• Last Update Posted: 2014-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anti HLA antibody level	after IVIG infusion

Secondary Outcome Measures

Name	Time	Method
Number of patients transplanted	at the end of study

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States