Desensitization Protocol for Deceased Donor List
This study is currently recruiting participants.
Verified February 2014 by University of Miami
Information provided by (Responsible Party):
Junichiro Sageshima, University of Miami
First received: July 12, 2012
Last updated: February 8, 2014
Last verified: February 2014
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.
Transplant; Failure, Kidney
||Observational Model: Case-Only
Time Perspective: Retrospective
||Desensitization Protocol for Deceased Donor List
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2014 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||7 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01642225
|University of Miami
|Miami, Florida, United States, 33136 |
|Contact: Junichiro Sageshima, M.D. 305-355-5315 firstname.lastname@example.org |
|Contact: Lois Hanson, R.N. 305-355-5315 email@example.com |
|Principal Investigator: Junichiro Sageshima, M.D. |
University of Miami
||Junichiro Sageshima, M.D.
||University of Miami
No publications provided
||Junichiro Sageshima, Associate Professor of Clinical, University of Miami
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 12, 2012
||February 8, 2014
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 22, 2014