Improving Transplant Options of Highly Sensitized Recipients Using IGIV-C, 10%

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00090194
First received: August 25, 2004
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to determine if IGIV-C, 10% will be effective in converting a donor-recipient crossmatch status from positive to negative. The crossmatch test is used to determine if the donor tissue and recipient tissue are compatible. The study will also evaluate if IGIV-C, 10% will allow successful kidney transplantation in a patient who otherwise would not be able to receive a transplant. Three dose levels of IGIV-C, 10% will be evaluated to determine what dose level is most effective.


Condition Intervention Phase
Kidney Failure, Chronic
Biological: Immune Globulin Intravenous (Human), 10%
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Immune Globulin Intravenous (Human), 10%, Manufactured by Chromatography Process (IGIV-C, 10%), as an Agent to Reduce Anti-HLA Antibodies and Improve Transplantation Results in Cross Match Positive Living Donor Kidney Allograft Recipients

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Monitoring of crossmatch conversion rate after one infusion of IGIV [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Graft survival and function
  • average percentage panel reactive antibodies (PRA) reduction
  • donor-specific unresponsiveness and allo-responsiveness in ESRD patients
  • subject survival
  • safety endpoints, including incidence rates of infection, adverse events, and hospitalizations

Enrollment: 56
Study Start Date: June 2003
Study Completion Date: March 2004
Arms Assigned Interventions
Experimental: Low Dose
0.5 gm/kg at 5 days pre-transplant and 7 days post-transplant
Biological: Immune Globulin Intravenous (Human), 10%
Experimental: Middle Dose
1.0 gm/kg at 5 days pre-transplant and 7 days post-transplant
Biological: Immune Globulin Intravenous (Human), 10%
Experimental: High Dose
2.0 gm/kg at 5 days pre-transplant and 7 days post-transplant
Biological: Immune Globulin Intravenous (Human), 10%

Detailed Description:

Kidney transplantation has emerged as the treatment of choice for patients with end-stage renal disease (ESRD). Preliminary data suggest that IGIV therapy could have significant benefits in modifying allograft rejection episodes, stabilizing long-term allograft function, and reducing ischemia/reperfusion injury.

Qualified patients will have an in-vitro assessment of the ability of IGIV-C, 10% to convert the donor-specific crossmatch (cytotoxic assay) from positive to negative. Those patients with successful in-vitro conversion of the donor-specific crossmatch assay will be randomized to receive IGIV-C, 10% intravenously at a dose of either 2 gm/kg, 1 gm/kg, or 0.5 gm/kg. IGIV-C, 10% will be administered 3 to 5 days prior to planned transplantation and, if transplantation is successful, 7 days post-transplant. If after receiving the IGIV-C infusion the donor-specific crossmatch reveals that cell death has fallen to 20% or less above background, the crossmatch will be considered negative. If after receiving one infusion the crossmatch remains positive, additional IGIV-C infusions may be administered at one-month intervals, up to 4 infusions. A repeat crossmatch must be obtained after each infusion. Patients will be followed for 12 months post-transplant. Concomitant therapy will include a standard immunosuppression regimen of mycophenolate mofetil, tacrolimus, and prednisone following induction therapy with thymoglobulin.

  Eligibility

Ages Eligible for Study:   1 Year to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Recipient:

  • End-stage renal disease
  • No known contraindications for therapy with IGIV-C, 10%
  • Have identified a living kidney donor
  • Positive crossmatch with the intended donor
  • Parent or guardian willing to provide consent, if applicable

Exclusion Criteria for Recipient:

  • Pregnant or breastfeeding
  • Women of child-bearing age who are not willing or able to practice approved methods of contraception
  • HIV infection
  • Hepatitis B or hepatitis C infection
  • History of positive tuberculin skin test
  • Selective IgA deficiency, known anti-IgA antibodies, or history of severe allergy to any part of the clinical trial material
  • Have received or will receive multiple organ transplants
  • Any licensed or investigational live attenuated vaccine within 2 months of the screening visit
  • Patients deemed unable to comply with the protocol
  • Heart attack within 1 year of screening
  • History of clinically significant thrombotic episodes or active peripheral vascular disease
  • Investigational agents within 4 weeks of study entry

Inclusion Criteria for Donor:

  • Positive donor-specific crossmatch with the intended recipient
  • ECOG performance status 0 or 1
  • Excellent health
  • Acceptable laboratory parameters
  • Compatible blood type
  • Normal heart and lung evaluations
  • Parent or guardian willing to provide consent, if applicable
  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: NCT00090194

Locations
United States, Alabama
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
United States, Arizona
Banner Good Samaritan Regional Medical Center
Phoenix, Arizona, United States, 85006
United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
University of San Francisco
San Francisco, California, United States, 94117
California Pacific Medical Center
San Francisco, California, United States, 94115
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
University of Massachusetts Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
University of Michigan Hospitals
Ann Arbor, Michigan, United States, 48109
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45219
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37235
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Investigators
Study Chair: Stanley C. Jordan, MD Department of Pediatrics, Cedars-Sinai Medical Center
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00090194     History of Changes
Other Study ID Numbers: DAIT IG03
Study First Received: August 25, 2004
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Kidney Transplantation
Transplantation, Homologous
HLA Antigens
Autoantibodies
Immunoglobulins, Intravenous
Living Donors
Dose-Response Relationship, Immunologic

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

ClinicalTrials.gov processed this record on August 18, 2014