A Prospective, Global, Multi-center, Treatment Registry Study of Intravenous Immunoglobulin Maintenance Therapy in Alloantibody Positive Renal Allograft Recipients

NCT02115503•Databean

Summary

The purpose of this treatment registry study is to determine if monthly infusions of Intravenous Immunoglobulin (IVIg) for 6 months will neutralize donor specific antibodies that are thought to be responsible for chronic rejection episodes in renal transplant subjects. 162 renal transplant subjects will receive IVIg 5% at 2gm/kg/month for 6 months and be followed for 3 years.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject is 18 years of age or older
•Able to provide voluntary written informed consent
•Renal transplant recipient at least 1 month post-transplant
•On stable doses of maintenance immunosuppression for at least 14 days prior to study entry and remains on stable maintenance doses for the duration of the study
•Presence of DSA greater than or equal to 1000 mean fluorescence intensity (MFI) single antigen bead assay via Luminex (normalized 2,000 - 15,000 MFI, inclusive) measured within 6 months prior to consent
•Female subjects must be post-menopausal for at least 1 year, or surgically sterilized, or must agree to use two effective methods of birth control from the time of consent through 30 days after the last dose of IVIg.
•Male subjects must be surgically sterilized, or must agree to use two effective methods of birth control from the time of consent through 30 days after the last dose of IVIg
•Subject is compliant and intends to be available for follow-up study period of 3 years

Exclusion Criteria

•Multi-organ transplant
•History of anaphylactic or severe systemic reactions to human immunoglobulin
•IgA deficient subjects with antibodies against IgA and a history of hypersensitivity
•Serum creatinine \> 3.0 mg/dL within 90 days prior to consent
•Recipients of ABO incompatible kidney transplants
•Acute rejection within 180 days (6 months) prior to consent defined as:
•1. Biopsy proven acute Cellular Rejection \[Banff grade I (including IA and IB), grade II (including IIA and IIB) or grade III\]; or
•2. an antibody-mediated rejection with C4d positivity, or
•4. Clinical signs and symptoms of acute rejection including elevated creatinine, fever over 100 degrees, pain or tenderness around the transplanted kidney, fluid retention of the hands, legs, feet, ankles or eyelids, sudden weight gain (2-4 pounds in a day, or 5 pounds or more in a week), decrease in urine output with the same amount of fluid intake, or dark yellow or orange urine output, flu-like symptoms, such as chills, aches, tiredness, dizziness, nausea, loss of appetite, weakness, fatigue, vomiting or general sense of not feeling well (Note: NOT all signs and symptoms need to be present to document acute rejection)
•Evidence of proteinuria (\> 3 grams) within 90 days (3 months) prior to consent
+19 more criteria

Locations (8)

St Vincent's Transplant Research Institute

Los Angeles, California, United States

University of California Davis Health Systems

Sacramento, California, United States

University of Colorado, Denver

Aurora, Colorado, United States

University of Miami

Miami, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Cornell Medical Center

New York, New York, United States

Baylor Research Institute

Fort Worth, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Key Dates

Start Date

July 1, 2014

Primary Completion Date

August 1, 2019

Completion Date

April 1, 2020

Last Updated

February 20, 2024

Enrollment

ACTUAL participants

Conditions

Renal Transplant Recipients With Anti-HLA Antibodies