Use of Immune Globulin Plus Rituximab for Desensitization in Highly HLA Sensitized Patients Await… (NCT01178216) | Clinical Trial Compass
CompletedPhase 1/2
Use of Immune Globulin Plus Rituximab for Desensitization in Highly HLA Sensitized Patients Awaiting Deceased Donor Kidney Transplantation
United States41 participantsStarted 2013-09
Plain-language 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 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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 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.