Improving Transplant Options of Highly Sensitized Recipients Using IGIV-C, 10% (NCT00090194) | Clinical Trial Compass
TerminatedPhase 2
Improving Transplant Options of Highly Sensitized Recipients Using IGIV-C, 10%
United States56 participantsStarted 2003-06
Plain-language 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.
Who can participate
Age range1 Year – 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 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
What they're measuring
1
Monitoring of crossmatch conversion rate after one infusion of IGIV
Trial details
NCT IDNCT00090194
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)