Status:
TERMINATED
Improving Transplant Options of Highly Sensitized Recipients Using IGIV-C, 10%
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Kidney Failure, Chronic
Eligibility:
All Genders
1-70 years
Phase:
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Recipient:
- 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
- Exclusion Criteria for Recipient:
- 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
- Inclusion Criteria for Donor:
- Positive donor-specific crossmatch with the intended recipient
- ECOG performance status 0 or 1
- Excellent health
- Acceptable laboratory parameters
- Compatible blood type
- Normal heart and lung evaluations
- Parent or guardian willing to provide consent, if applicable
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00090194
Start Date
June 1 2003
End Date
March 1 2004
Last Update
January 11 2017
Active Locations (16)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
Banner Good Samaritan Regional Medical Center
Phoenix, Arizona, United States, 85006
3
UCLA Medical Center
Los Angeles, California, United States, 90095
4
California Pacific Medical Center
San Francisco, California, United States, 94115