Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT00090194
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
70 Years
Study:
NCT00090194
Study Brief:
Protocol Section:
NCT00090194