Desensitization Protocol for Deceased Donor List

NCT ID: NCT01642225

Last Updated: 2014-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Transplant; Failure, Kidney

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Junichiro Sageshima

Associate Professor of Clinical

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Junichiro Sageshima, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20120052

Identifier Type: -

Identifier Source: org_study_id

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