Improving Transplant Options of Highly Sensitized Recipients Using IGIV-C, 10%
- Conditions
- Kidney Failure, Chronic
- Interventions
- Biological: Immune Globulin Intravenous (Human), 10%
- Registration Number
- NCT00090194
- Brief Summary
The purpose of this study is to determine if IGIV-C, 10% will be effective in converting a donor-recipient crossmatch status from positive to negative. The crossmatch test is used to determine if the donor tissue and recipient tissue are compatible. The study will also evaluate if IGIV-C, 10% will allow successful kidney transplantation in a patient who otherwise would not be able to receive a transplant. Three dose levels of IGIV-C, 10% will be evaluated to determine what dose level is most effective.
- Detailed Description
Kidney transplantation has emerged as the treatment of choice for patients with end-stage renal disease (ESRD). Preliminary data suggest that IGIV therapy could have significant benefits in modifying allograft rejection episodes, stabilizing long-term allograft function, and reducing ischemia/reperfusion injury.
Qualified patients will have an in-vitro assessment of the ability of IGIV-C, 10% to convert the donor-specific crossmatch (cytotoxic assay) from positive to negative. Those patients with successful in-vitro conversion of the donor-specific crossmatch assay will be randomized to receive IGIV-C, 10% intravenously at a dose of either 2 gm/kg, 1 gm/kg, or 0.5 gm/kg. IGIV-C, 10% will be administered 3 to 5 days prior to planned transplantation and, if transplantation is successful, 7 days post-transplant. If after receiving the IGIV-C infusion the donor-specific crossmatch reveals that cell death has fallen to 20% or less above background, the crossmatch will be considered negative. If after receiving one infusion the crossmatch remains positive, additional IGIV-C infusions may be administered at one-month intervals, up to 4 infusions. A repeat crossmatch must be obtained after each infusion. Patients will be followed for 12 months post-transplant. Concomitant therapy will include a standard immunosuppression regimen of mycophenolate mofetil, tacrolimus, and prednisone following induction therapy with thymoglobulin.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 56
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low Dose Immune Globulin Intravenous (Human), 10% 0.5 gm/kg at 5 days pre-transplant and 7 days post-transplant Middle Dose Immune Globulin Intravenous (Human), 10% 1.0 gm/kg at 5 days pre-transplant and 7 days post-transplant High Dose Immune Globulin Intravenous (Human), 10% 2.0 gm/kg at 5 days pre-transplant and 7 days post-transplant
- Primary Outcome Measures
Name Time Method Monitoring of crossmatch conversion rate after one infusion of IGIV
- Secondary Outcome Measures
Name Time Method Graft survival and function average percentage panel reactive antibodies (PRA) reduction subject survival safety endpoints, including incidence rates of infection, adverse events, and hospitalizations donor-specific unresponsiveness and allo-responsiveness in ESRD patients
Trial Locations
- Locations (16)
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States
University of Massachusetts Medical Center
🇺🇸Worcester, Massachusetts, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of San Francisco
🇺🇸San Francisco, California, United States
University of Michigan Hospitals
🇺🇸Ann Arbor, Michigan, United States
Banner Good Samaritan Regional Medical Center
🇺🇸Phoenix, Arizona, United States
University of Miami
🇺🇸Miami, Florida, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Children's Hospital of Alabama
🇺🇸Birmingham, Alabama, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States