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 range
1 Year – 70 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)