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

Study Overview
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Brief Summary
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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
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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.

Official Title
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IVIG Treatment for Live-donor Renal Transplant Patients With a Positive Crossmatch and in Patients With High PRA

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Drug: intravenous immune globulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1 intravenous immune globulin<br>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 | Drug: intravenous immune globulin<br>* 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments<br>|
| Other: Group 2 intravenous immune globulin<br>Intravenous immune globulin for patients who have living donors with positive crossmatch results. | Drug: intravenous immune globulin<br>* 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elimination of Donor Specific Antibodies |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative B and T Cell Crossmatch |  | 1year |