Status:
COMPLETED
An Evaluation of IV Gamma Globulin As a Method to Improve Kidney Transplant Survival in Patients With End-Stage Renal Disease Who Are Highly Sensitized to Transplant Antigens
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
End-Stage Renal Disease
Kidney Transplantation
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
This study is designed to test the clinical and laboratory observations that suggest IVIG given before and after kidney transplant to patients who are sensitized (highly sensitive) to certain transpla...
Detailed Description
Kidney transplantation is the treatment of choice for patients with end-stage renal disease (ESRD). However, many patients do not receive this treatment due to immune sensitization to HLA antigens. IV...
Eligibility Criteria
Inclusion Criteria
You may be eligible for this study if you:
- Are 12 years of age or older.
- Have end-stage renal disease.
- Currently receive either hemo- or peritoneal dialysis.
- Have an elevated (> 50%) level of panel reactive antibodies (PRA level) on 3 consecutive monthly tests.
- Agree to practice sexual abstinence or to use effective means of birth control/contraception during the study and for 1 year after.
Exclusion Criteria
You will not be eligible for this study if you:
- Have received IVIG for any reason within 6 months prior to enrollment.
- Are HIV positive.
- Are Hepatitis B e-antigen/hepatitis B viral DNA-positive.
- Have selective IgA deficiency or have known antibodies to IgA.
- Are allergic to human immune globulin.
- Are pregnant or breast-feeding.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2003
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00000935
End Date
June 1 2003
Last Update
January 11 2017
Active Locations (1)
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1
Ann Limberger
Rockville, Maryland, United States, 20850