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Sponsors and Collaborators: |
Cedars-Sinai Medical Center Genentech Biogen Idec |
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Information provided by: | Cedars-Sinai Medical Center |
ClinicalTrials.gov Identifier: | NCT00642655 |
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.
Condition | Intervention | Phase |
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Kidney Transplant |
Drug: IVIG and Rituximab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Trial to Investigate the Safety and Efficacy of Rituximab and IVIG as Agents to Desensitize Highly-HLA Sensitized Dialysis Patients Awaiting Kidney Transplantation |
Enrollment: | 20 |
Study Start Date: | September 2005 |
Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Patients eligible for the study will be those who have anti-HLA antibody (Panel Reactive Antibody {PRA}) of >30%. If patients meet these criteria, patients will be asked to have an assessment of the ability of IVIG to reduce the anti-HLA antibodies activity in the test tube. Patients will receive IVIG 2gm/kg x1 on hemodialysis. Seven days later, patients will receive Rituximab 1gm in the CSMC Infusion Center as per protocol for Rituximab infusion. The second Rituximab infusion will be on day #22. Additional IVIG infusion will be given at month one.
Patients will continue to be followed for an additional 12 months after the last IVIG infusion and will be asked to return for follow up visits at month
1 through 5, month 7 and 12.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Exclusion Criteria:
Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
Laboratory Exclusion Criteria (at Screening)
United States, California | |
8700 Beverly Blvd. | |
Los Angeles, California, United States, 90048 |
Principal Investigator: | Stanley C. Jordan, MD | Cedars-Sinai Medical Center |
Study Director: | Ashley A Vo, PharmD | Cedars-Sinai Medical Center |
Responsible Party: | Cedars-Sinai Medical Center ( Stanley C. Jordan, MD ) |
Study ID Numbers: | U3176s |
Study First Received: | March 19, 2008 |
Last Updated: | March 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00642655 History of Changes |
Health Authority: | United States: Food and Drug Administration |
IVIG Rituximab Highly Sensitized Kidney Transplantation |
Antibodies Immunologic Factors Immunoglobulins, Intravenous Rituximab |
Rho(D) Immune Globulin Antirheumatic Agents Immunoglobulins |
Immunologic Factors Antineoplastic Agents Rituximab Immunoglobulins, Intravenous |
Therapeutic Uses Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |