Status:
COMPLETED
Use of Immune Globulin Plus Rituximab for Desensitization in Highly HLA Sensitized Patients Awaiting Deceased Donor Kidney Transplantation
Lead Sponsor:
Stanley Jordan, MD
Collaborating Sponsors:
Genentech, Inc.
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
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 p...
Detailed Description
Organ transplantation offers the only hope for a normal life for patients with end-stage renal disease on dialysis. For patients with antibodies to human leukocyte antigens (HLA), transplantation is e...
Eligibility Criteria
Inclusion
- End-stage renal disease.
- No known contraindications for therapy with IGIV10%/Rituximab.
- Age 18-70 years at the time of screening.
- 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.
- Subject/Parent/Guardian must be able to understand and provide informed consent.
Exclusion
- Lactating or pregnant females.
- Pediatric patients \<18 years of age
- Women of child-bearing age who are not willing or able to practice FDA-approved forms of contraception.
- HIV-positive subjects.
- Subjects who test positive for HBV infection \[positive HBVsAg, HBVcAg, or HBVeAg/DNA\] or HCV infection \[positive Anti-HCV (EIA) and confirmatory HCV RIBA\].
- Subjects with active TB.
- 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.
- Subjects who have received or for whom multiple organ transplants are planned.
- 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 \[IMOVAX Rabies I.D., RabAvert\])
- 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.
- Individuals deemed unable to comply with the protocol.
- 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.
- Subjects with a known history of previous myocardial infarction within one year of screening.
- Subjects with a history of clinically significant thrombotic episodes, and subjects with active peripheral vascular disease.
- Use of investigational agents within 4 weeks of participation.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2017
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01178216
Start Date
September 1 2013
End Date
July 28 2017
Last Update
October 26 2018
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048