NCT00586716

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 12 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	intravenous immune globulin	0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments

Timeline

• Start date: 2004-11-01
• Primary completion: 2009-09-01
• Completion: 2009-10-01
• First posted: 2008-01-04
• Last updated: 2017-01-09
• Results posted: 2016-06-06