Desensitization Protocol for Deceased Donor List

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Miami
Sponsor:
Information provided by (Responsible Party):
Junichiro Sageshima, University of Miami
ClinicalTrials.gov Identifier:
NCT01642225
First received: July 12, 2012
Last updated: February 8, 2014
Last verified: February 2014
  Purpose

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
Transplant; Failure, Kidney

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Desensitization Protocol for Deceased Donor List

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Anti HLA antibody level [ Time Frame: after IVIG infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients transplanted [ Time Frame: at the end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   7 Years to 75 Years
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642225

Contacts
Contact: Junichiro Sageshima, M.D. 305-355-5315 jsageshima@med.miami.edu
Contact: Lois Hanson, R.N. 305-355-5315 lhanson2@med.miami.edu

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Junichiro Sageshima, M.D.    305-355-5315    jsageshima@med.miami.edu   
Contact: Lois Hanson, R.N.    305-355-5315    lhanson2@med.miami.edu   
Principal Investigator: Junichiro Sageshima, M.D.         
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Junichiro Sageshima, M.D. University of Miami
  More Information

No publications provided

Responsible Party: Junichiro Sageshima, Associate Professor of Clinical, University of Miami
ClinicalTrials.gov Identifier: NCT01642225     History of Changes
Other Study ID Numbers: 20120052
Study First Received: July 12, 2012
Last Updated: February 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 18, 2014