Desensitization Protocol for Deceased Donor List
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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 |
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
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 |
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.
Contacts and Locations| Contact: Junichiro Sageshima, M.D. | 305-355-5315 | jsageshima@med.miami.edu |
| Contact: Lois Hanson, R.N. | 305-355-5315 | lhanson2@med.miami.edu |
| 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. | |
| 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: | July 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Renal Insufficiency Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013