End Stage Renal Disease Clinical Trial
Official title:
Use of Immune Globulin Intravenous (Human), 10% (IVIG), Plus Rituximab as Agents to Reduce Donor Specific Antibodies, Improve Transplant Rates and Outcomes in Highly-HLA Sensitized Patients Awaiting Deceased Donor Kidney Transplantation
Verified date | September 2018 |
Source | Cedars-Sinai Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This single center, Phase I/II, exploratory study has been modified to a safety/efficacy study providing all patients with IVIG and Rituximab. The trial will examine the safety and efficacy of human polyclonal IVIG 10%, when given at [2.0 gm/kgx2], + Rituximab 1gm to reduce donor-specific antibodies (DSA) to a level that is permissive for transplantation in 75 subjects (adults only ages >18 yrs) who are highly-HLA sensitized and are awaiting deceased donor kidney transplant. Once transplant offers are entertained, a donor-specific crossmatch will be performed. If acceptable crossmatches and DSA levels are seen, the patients will proceed to DD transplantation. Patients receiving transplants will receive an additional dose of IVIG at transplantation (within 10 days) and will receive additional doses of Rituximab 1g at 3M post transplant if DSA levels remain or become positive at 6M if de novo DSA occur. Patients who are desensitized and not transplanted at 9M after desensitization will have completed the study and can be treated as best judged by their physician.
Status | Completed |
Enrollment | 41 |
Est. completion date | July 28, 2017 |
Est. primary completion date | July 28, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. End-stage renal disease. 2. No known contraindications for therapy with IGIV10%/Rituximab. 3. Age 18-70 years at the time of screening. 4. PRA> 30% demonstrated on 3 consecutive samples, UNOS wait time sufficient to allow DD offers, history of sensitizing events, positive crossmatch with the intended donor. 5. Subject/Parent/Guardian must be able to understand and provide informed consent. Exclusion Criteria: 1. Lactating or pregnant females. 2. Pediatric patients <18 years of age 3. Women of child-bearing age who are not willing or able to practice FDA-approved forms of contraception. 4. HIV-positive subjects. 5. Subjects who test positive for HBV infection [positive HBVsAg, HBVcAg, or HBVeAg/DNA] or HCV infection [positive Anti-HCV (EIA) and confirmatory HCV RIBA]. 6. Subjects with active TB. 7. Subjects with selective IgA deficiency, those who have known anti-IgA antibodies, and those with a history of anaphylaxis or severe systemic responses to any part of the clinical trial material. 8. Subjects who have received or for whom multiple organ transplants are planned. 9. Recent recipients of any licensed or investigational live attenuated vaccine(s) within two months of the screening visit (including but not limited to any of the following: - Adenovirus [Adenovirus vaccine live oral type 7] - Varicella [Varivax] - Hepatitis A [VAQTA] - Rotavirus [Rotashield] - Yellow fever [Y-F-Vax] - Measles and mumps [Measles and mumps virus vaccine live] - Measles, mumps, and rubella vaccine [M-M-R-II] - Sabin oral polio vaccine - Rabies vaccines [IMOVAX Rabies I.D., RabAvert]) 10. A significantly abnormal general serum screening lab result defined as a WBC < 3.0 X 103/ml, a Hgb < 8.0 g/dL, a platelet count < 100 X 103/ml, , an SGOT > 5X upper limit of normal, and an SGPT >5X upper limit of normal range. 11. Individuals deemed unable to comply with the protocol. 12. Subjects with active CMV or EBV infection as defined by CMV-specific serology (IgG or IgM) and confirmed by quantitative PCR with or without a compatible illness. 13. Subjects with a known history of previous myocardial infarction within one year of screening. 14. Subjects with a history of clinically significant thrombotic episodes, and subjects with active peripheral vascular disease. 15. Use of investigational agents within 4 weeks of participation. |
Country | Name | City | State |
---|---|---|---|
United States | Cedars-Sinai Medical Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Stanley Jordan, MD | Genentech, Inc. |
United States,
Jordan SC, Peng A, Vo AA. Therapeutic strategies in management of the highly HLA-sensitized and ABO-incompatible transplant recipients. Contrib Nephrol. 2009;162:13-26. doi: 10.1159/000170864. Epub 2008 Oct 31. Review. — View Citation
Vo AA, Lukovsky M, Toyoda M, Wang J, Reinsmoen NL, Lai CH, Peng A, Villicana R, Jordan SC. Rituximab and intravenous immune globulin for desensitization during renal transplantation. N Engl J Med. 2008 Jul 17;359(3):242-51. doi: 10.1056/NEJMoa0707894. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients That Underwent Transplantation | This trial is designed to determine if Rituximab + IVIG can improve rates of transplantation for highly-HLA sensitized DD candidates on the UNOS waiting list over a 9M period of time after completion of treatment. | 9 month | |
Secondary | Number of Patients With Allograft Survival | Graft survival in study participants | 12 months | |
Secondary | Reduction in Anti-HLA Antibodies | Number of patients with a reduction in anti-HLA antibodies. | 9 months | |
Secondary | Number of Acute Rejection Episodes | Number of rejection episodes in study participants | 12 months | |
Secondary | Number of Patients Reporting a Serious Infection | Infection rate in study participants | 12 months | |
Secondary | Number of Adverse Events, Toxicity Assessments | Adverse effects in study participants | 12 months |
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