Intravenous Immune Globulin (IVIG) Treatment Protocol in Kidney Transplant Patients

Not Applicable

Terminated

• Conditions: End Stage Renal Disease
• Interventions: Drug: intravenous immune globulin

• Registration Number: NCT00586716
• Lead Sponsor: Loma Linda University

Brief 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.

Detailed Description

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. There are two arms in the study, one in which IVIG is administered to patients who have living donors with positive crossmatch results, and another in which intravenous immune globulin is administered to patients with no living donor and have a PRA greater than 30% for 3 consecutive months and a crossmatch with a cadaveric donor while on kidney transplant waiting list. 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.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-04
• Primary Completion: 2009-09
• Study Completion: 2009-10
• Results First Submitted: 2014-05-29
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-28
• Results First Posted: 2016-06-06
• Last Update Submitted: 2016-11-17
• Last Update Posted: 2017-01-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 intravenous immune globulin	intravenous immune globulin	Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list
Group 2 intravenous immune globulin	intravenous immune globulin	Intravenous immune globulin for patients who have living donors with positive crossmatch results.

Primary Outcome Measures

Name	Time	Method
Elimination of Donor Specific Antibodies	1 year

Secondary Outcome Measures

Name	Time	Method
Negative B and T Cell Crossmatch	1year