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

This study has been terminated.
(Insufficient recruitment)
Sponsor:
Information provided by:
Loma Linda University
ClinicalTrials.gov Identifier:
NCT00586716
First received: December 21, 2007
Last updated: October 8, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention
End Stage Renal Disease
Drug: invenous immune globulins

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: IVIG Treatment for Live-donor Renal Transplant Patients With a Positive Crossmatch and in Patients With High PRA

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • elimination of donor specific antibodies [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • negative B and T cell crossmatch [ Time Frame: 1year ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: November 2004
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1
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: invenous immune globulins
0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments
Group 2
Patients who have living donors with positive crossmatch results.
Drug: invenous immune globulins
0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments

  Eligibility

Ages Eligible for Study:   12 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586716

Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Okechukwu Ojogho, MD Loma Linda Universtiy Adventist Health Sciences Center
  More Information

No publications provided

Responsible Party: Okechukwu Ojogho, MD, Loma Linda University Adventist Health Sciences Center
ClinicalTrials.gov Identifier: NCT00586716     History of Changes
Other Study ID Numbers: 54298
Study First Received: December 21, 2007
Last Updated: October 8, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014