Rituximab and Intravenous Immunoglobulin (IVIG) for Desensitization in Renal Transplantation (NCT00642655) | Clinical Trial Compass
CompletedPhase 1/2
Rituximab and Intravenous Immunoglobulin (IVIG) for Desensitization in Renal Transplantation
United States20 participantsStarted 2005-09
Plain-language summary
The purpose of this study is to examine the safety and efficacy of IVIG in combination with Rituximab to lower the level of HLA-sensitive antibodies and block their ability to attack a transplanted organ in patients who are highly HLA-sensitized and are awaiting transplantation.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Patients eligible for the study will be those who have anti-HLA antibody (Panel Reactive Antibody \[PRA\]) of \>30% and are eligible for transplantation at Cedars-Sinai Medical Center. We currently anticipate entering 20 patients over the course of the study. We currently have \~100 patients on our wait list that would meet the above criteria. Patients will be selected based on the ability of IVIG to inhibit the cytotoxic anti-HLA antibody activity in vitro. They will then receive IVIG 2gm/kg X1 on day 1 while on hemodialysis. Seven days later, the patients will receive Rituxan® 1gm in the CSMC Cancer Infusion Center as per protocol for Rituxan® infusion. The second Rituxan® infusion will be on day#22. The patients will have monitoring of anti-HLA antibody and outlined tests as shown above.
* Able and willing to give written informed consent and comply with the requirements of the study protocol
* Adequate liver function, as indicated by normal liver function tests (NL: AST, ALT, Bilirubin and negative tests for hepatitis C and hepatitis B.
* Negative serum pregnancy test (for women of child bearing age)
* Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.
Exclusion Criteria:
* Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
* Receipt of a l…