Intravenous Immune Globulin (IVIG) Treatment Protocol in Kidney Transplant Patients
Information source: Loma Linda University
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: End Stage Renal Disease
Intervention: invenous immune globulins (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Loma Linda University Official(s) and/or principal investigator(s):
Okechukwu Ojogho, MD, Principal Investigator, Affiliation: Loma Linda Universtiy Adventist Health Sciences Center
Overall contact:
Tracy A Bock, RN, MBA, Phone: (909) 558-8121, Email: Tbock@llu.edu
Summary
The purpose of this study is to test the clinical and laboratory observations of IVIG therapy
in the highly sensitized patient. We will study the effects of patients treated with IVIG or
Cytogam in combination with plasmaphoresis to modulate the immune response in highly
sensitized patients. The goal is to convert a positive crossmatch to a compatible crossmatch
that would allow living related transplant to take place or to shorten time on the transplant
waiting list.
Clinical Details
Official title: IVIG Treatment for Live-Donor Renal Transplant Patients With a Positive Crossmatch and in Patients With High PRA
Study design: Treatment, Open Label, Parallel Assignment, Efficacy Study
Primary outcome: elimination of donor specific antibodies
Secondary outcome: negative B and T cell crossmatch
Eligibility
Minimum age: 12 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 12 years of age or older
- diagnosed with end stage renal disease
- currently receiving either hemodialysis or peritoneal dialysis
- active on the kidney or kidney/pancreas transplant list
- medical clearance of the kidney donor if live related transplant
- elevated panel reactive antibody (PRA) greater that 30% for 3 consecutive monthly
tests and one positive crossmatch with a cadaveric donor while on the transplant
waiting list
Exclusion Criteria:
- received IVIG within 6 months prior to enrollment
- HIV positive
- Positive Hepatitis Be-antigen and/or hepatitis B viral DNA
- Selective IgA deficiency or known antibodies to IgA
- Allergy to human immune globulin
- Pregnant or breast feeding
Locations and Contacts
Tracy A Bock, RN, MBA, Phone: (909) 558-8121, Email: Tbock@llu.edu
Loma Linda University Medical Center, Loma Linda, California 92354, United States; Recruiting
Okechukwu Ojogho, MD, Principal Investigator
Additional Information
Starting date: November 2004
Ending date: November 2011
Last updated: July 23, 2008
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