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Desensitization Protocol for Deceased Donor List

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01642225
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : October 20, 2014
Information provided by (Responsible Party):
Junichiro Sageshima, 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.

Condition or disease
Transplant; Failure, Kidney

Detailed Description:


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.

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Study Type : Observational
Actual Enrollment : 180 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Desensitization Protocol for Deceased Donor List
Study Start Date : June 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Primary Outcome Measures :
  1. Anti HLA antibody level [ Time Frame: after IVIG infusion ]

Secondary Outcome Measures :
  1. Number of patients transplanted [ Time Frame: at the end of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Approximately 100 subjects are expected to participate from 2007 to current, and another 100 subjects are expected to participate during the next 12-month period.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01642225

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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
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Principal Investigator: Junichiro Sageshima, M.D. University of Miami
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Responsible Party: Junichiro Sageshima, Associate Professor of Clinical, University of Miami Identifier: NCT01642225    
Other Study ID Numbers: 20120052
First Posted: July 17, 2012    Key Record Dates
Last Update Posted: October 20, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases