Improving Transplant Options of Highly Sensitized Recipients Using IGIV-C, 10%
Evaluation of Immune Globulin Intravenous (Human), 10%, Manufactured by Chromatography Process (IGIV-C, 10%), as an Agent to Reduce Anti-HLA Antibodies and Improve Transplantation Results in Cross Match Positive Living Donor Kidney Allograft Recipients
1 other identifier
interventional
56
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2003
Shorter than P25 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 25, 2004
CompletedFirst Posted
Study publicly available on registry
August 26, 2004
CompletedJanuary 11, 2017
January 1, 2017
August 25, 2004
January 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Monitoring of crossmatch conversion rate after one infusion of IGIV
Secondary Outcomes (5)
Graft survival and function
average percentage panel reactive antibodies (PRA) reduction
donor-specific unresponsiveness and allo-responsiveness in ESRD patients
subject survival
safety endpoints, including incidence rates of infection, adverse events, and hospitalizations
Study Arms (3)
Low Dose
EXPERIMENTAL0.5 gm/kg at 5 days pre-transplant and 7 days post-transplant
Middle Dose
EXPERIMENTAL1.0 gm/kg at 5 days pre-transplant and 7 days post-transplant
High Dose
EXPERIMENTAL2.0 gm/kg at 5 days pre-transplant and 7 days post-transplant
Interventions
Eligibility Criteria
You may qualify if:
- End-stage renal disease
- No known contraindications for therapy with IGIV-C, 10%
- Have identified a living kidney donor
- Positive crossmatch with the intended donor
- Parent or guardian willing to provide consent, if applicable
You may not qualify if:
- Pregnant or breastfeeding
- Women of child-bearing age who are not willing or able to practice approved methods of contraception
- HIV infection
- Hepatitis B or hepatitis C infection
- History of positive tuberculin skin test
- Selective IgA deficiency, known anti-IgA antibodies, or history of severe allergy to any part of the clinical trial material
- Have received or will receive multiple organ transplants
- Any licensed or investigational live attenuated vaccine within 2 months of the screening visit
- Patients deemed unable to comply with the protocol
- Heart attack within 1 year of screening
- History of clinically significant thrombotic episodes or active peripheral vascular disease
- Investigational agents within 4 weeks of study entry
- Positive donor-specific crossmatch with the intended recipient
- ECOG performance status 0 or 1
- Excellent health
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Children's Hospital of Alabama
Birmingham, Alabama, 35233, United States
Banner Good Samaritan Regional Medical Center
Phoenix, Arizona, 85006, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
University of San Francisco
San Francisco, California, 94117, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
University of Miami
Miami, Florida, 33136, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
University of Massachusetts Medical Center
Worcester, Massachusetts, 01655, United States
University of Michigan Hospitals
Ann Arbor, Michigan, 48109, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37235, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Related Publications (5)
Akalin E, Ames S, Sehgal V, Fotino M, Daly L, Murphy B, Bromberg JS. Intravenous immunoglobulin and thymoglobulin facilitate kidney transplantation in complement-dependent cytotoxicity B-cell and flow cytometry T- or B-cell crossmatch-positive patients. Transplantation. 2003 Nov 27;76(10):1444-7. doi: 10.1097/01.TP.0000084200.40159.EC.
PMID: 14657683BACKGROUNDJordan S, Cunningham-Rundles C, McEwan R. Utility of intravenous immune globulin in kidney transplantation: efficacy, safety, and cost implications. Am J Transplant. 2003 Jun;3(6):653-64. doi: 10.1034/j.1600-6143.2003.00121.x.
PMID: 12780556BACKGROUNDJordan SC, Vo A, Bunnapradist S, Toyoda M, Peng A, Puliyanda D, Kamil E, Tyan D. Intravenous immune globulin treatment inhibits crossmatch positivity and allows for successful transplantation of incompatible organs in living-donor and cadaver recipients. Transplantation. 2003 Aug 27;76(4):631-6. doi: 10.1097/01.TP.0000080685.31697.FC.
PMID: 12973100BACKGROUNDJordan SC, Vo AA, Toyoda M, Tyan D, Nast CC. Post-transplant therapy with high-dose intravenous gammaglobulin: Applications to treatment of antibody-mediated rejection. Pediatr Transplant. 2005 Apr;9(2):155-61. doi: 10.1111/j.1399-3046.2005.00256.x.
PMID: 15787786BACKGROUNDZachary AA, Montgomery RA, Ratner LE, Samaniego-Picota M, Haas M, Kopchaliiska D, Leffell MS. Specific and durable elimination of antibody to donor HLA antigens in renal-transplant patients. Transplantation. 2003 Nov 27;76(10):1519-25. doi: 10.1097/01.TP.0000090868.88895.E0.
PMID: 14657698BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Stanley C. Jordan, MD
Department of Pediatrics, Cedars-Sinai Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2004
First Posted
August 26, 2004
Study Start
June 1, 2003
Study Completion
March 1, 2004
Last Updated
January 11, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will share
Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.