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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

Page last updated: February 12, 2009

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