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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00090194
Recruitment Status : Terminated
First Posted : August 26, 2004
Last Update Posted : January 11, 2017
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
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 or disease Intervention/treatment Phase
Kidney Failure, Chronic Biological: Immune Globulin Intravenous (Human), 10% Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2003
Actual Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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%

Primary Outcome Measures :
  1. Monitoring of crossmatch conversion rate after one infusion of IGIV

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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00090194

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
California Pacific Medical Center
San Francisco, California, United States, 94115
University of San Francisco
San Francisco, California, United States, 94117
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
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Stanley C. Jordan, MD Department of Pediatrics, Cedars-Sinai Medical Center

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the site
Identifier: SDY356
ImmPort study identifier is SDY356
Study Protocol  This link exits the site
Identifier: SDY356
ImmPort study identifier is SDY356
Study summary, -design, -demographics, -lab tests, -study files  This link exits the site
Identifier: SDY356
ImmPort study identifier is SDY356

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00090194     History of Changes
Other Study ID Numbers: DAIT IG03
First Posted: August 26, 2004    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.

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

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