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

Loma Linda University (LLU)

Status: Terminated

Conditions: End Stage Renal Disease

Treatments: Drug: intravenous immune globulin

Study type: Interventional

Funder types: Other

Identifiers

NCT00586716

54298

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 12 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Group 1 intravenous immune globulin

Other group

Description:

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

Treatment:

Drug: intravenous immune globulin

Group 2 intravenous immune globulin

Other group

Description:

Intravenous immune globulin for patients who have living donors with positive crossmatch results.

Treatment:

Drug: intravenous immune globulin