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
Completed · Phase 3 · Has a placebo group
Conditions studied: End-Stage Renal Disease, Kidney Transplantation
In brief
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 transplant antigens could result in reduced sensitization and reduced rates of kidney rejection. Some ESRD patients are highly sensitive to certain transplant antigens (foreign substances that activate the immune system) and must wait for a long time before a well-matched kidney becomes available. Transplant rejection is more likely among highly sensitized patients than in patients who are not highly sensitized. There is no proven method to improve a highly-sensitized patient's chances of receiving and keeping a transplanted kidney.
Key facts
- Study ID
- NCT00000935
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 100
- Expected to finish
- 2003-06-01
- Last updated by the study team
- 2017-01-11
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Ann Limberger — Rockville, Maryland, United States
Full record on ClinicalTrials.gov
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