Desensitization Protocol for Deceased Donor List
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 7 - 75 |
| Updated: | 11/8/2014 |
| Start Date: | June 2012 |
| End Date: | June 2014 |
| Contact: | Junichiro Sageshima, M.D. |
| Email: | jsageshima@med.miami.edu |
| Phone: | 305-355-5315 |
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.
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.
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.
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.
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.
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University of Miami A private research university with more than 15,000 students from around the...
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