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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00586716
• Other study ID #: 54298
• Status: Terminated
• Phase: N/A
• First received: December 21, 2007
• Last updated: October 8, 2009
• Start date: November 2004
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• invenous immune globulins
0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	elimination of donor specific antibodies		1 year	No
Secondary	negative B and T cell crossmatch		1year	No