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

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Failure, Chronic

Intervention: Immune Globulin Intravenous (Human), 10% (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Stanley C. Jordan, MD, Study Chair, Affiliation: Department of Pediatrics, Cedars-Sinai Medical Center

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.

Clinical Details

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 design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Monitoring of crossmatch conversion rate

Secondary outcome:

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

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

Minimum age: 1 Year. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Children's Hospital of Alabama, Birmingham, Alabama 35233, United States

Banner Good Samaritan Regional Medical Center, Phoenix, Arizona 85006, United States

University of San Francisco, San Francisco, California 94117, United States

UCLA Medical Center, Los Angeles, California 90095, United States

California Pacific Medical Center, San Francisco, California 94115, United States

Washington Hospital Center, Washington, District of Columbia 20010, United States

University of Miami, Miami, Florida 33136, United States

Emory University Hospital, Atlanta, Georgia 30322, United States

Indiana University Medical Center, Indianapolis, Indiana 46202, United States

University of Massachusetts Medical Center, Worcester, Massachusetts 01655, United States

University of Michigan Hospitals, Ann Arbor, Michigan 48109, United States

University of Cincinnati, Cincinnati, Ohio 45219, United States

Rhode Island Hospital, Providence, Rhode Island 02903, United States

Vanderbilt University Medical Center, Nashville, Tennessee 37235, United States

University of Texas Medical Branch, Galveston, Texas 77555, United States

Swedish Medical Center, Seattle, Washington 98104, United States

Additional Information

Related publications:

Akalin E, Ames S, Sehgal V, Fotino M, Daly L, Murphy B, Bromberg JS. Intravenous immunoglobulin and thymoglobulin facilitate kidney transplantation in complement-dependent cytotoxicity B-cell and flow cytometry T- or B-cell crossmatch-positive patients. Transplantation. 2003 Nov 27;76(10):1444-7.

Jordan S, Cunningham-Rundles C, McEwan R. Utility of intravenous immune globulin in kidney transplantation: efficacy, safety, and cost implications. Am J Transplant. 2003 Jun;3(6):653-64. Review.

Jordan SC, Vo A, Bunnapradist S, Toyoda M, Peng A, Puliyanda D, Kamil E, Tyan D. Intravenous immune globulin treatment inhibits crossmatch positivity and allows for successful transplantation of incompatible organs in living-donor and cadaver recipients. Transplantation. 2003 Aug 27;76(4):631-6.

Jordan SC, Vo AA, Toyoda M, Tyan D, Nast CC. Post-transplant therapy with high-dose intravenous gammaglobulin: Applications to treatment of antibody-mediated rejection. Pediatr Transplant. 2005 Apr;9(2):155-61. Review.

Zachary AA, Montgomery RA, Ratner LE, Samaniego-Picota M, Haas M, Kopchaliiska D, Leffell MS. Specific and durable elimination of antibody to donor HLA antigens in renal-transplant patients. Transplantation. 2003 Nov 27;76(10):1519-25.

Starting date: June 2003
Last updated: September 8, 2006

Page last updated: June 20, 2008

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