Use of Immune Globulin Plus Rituximab for Desensitization in Highly HLA Sensitized Patients Awaiting Deceased Donor Kidney Transplantation

Completed · Phase 1/Phase 2

Conditions studied: End Stage Renal Disease

In brief

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.

Key facts

Study ID

NCT01178216

Run by

Stanley Jordan, MD

People needed

41

Starts

2013-09-01

Expected to finish

2017-07-28

Last updated by the study team

2018-10-26

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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