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

NCT ID: NCT00586716

Last Updated: 2017-01-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2009-10-31

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.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 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 Type: OTHER

intravenous immune globulin

Intervention Type: DRUG

0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments

Group 2 intravenous immune globulin

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

Group Type: OTHER

intravenous immune globulin

Intervention Type: DRUG

0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments

Interventions

intravenous immune globulin

0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Okechukwu Ojogho, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda Universtiy Adventist Health Sciences Center

Other Identifiers

54298

Identifier Type: -

Identifier Source: org_study_id