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

Databean8 sites in 1 country52 target enrollmentJuly 2014

ConditionsRenal Transplant Recipients With Anti-HLA Antibodies

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Renal Transplant Recipients With Anti-HLA Antibodies
Sponsor: Databean
Enrollment: 52
Locations: 8
Primary Endpoint: Difference in mean change from screening to 36 months in graft survival and glomerular filtration rates (GFR)
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 2014

End Date

April 2020

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Databean

Responsible Party

Sponsor

Eligibility Criteria

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:
•Biopsy proven acute Cellular Rejection \[Banff grade I (including IA and IB), grade II (including IIA and IIB) or grade III\]; or
•an antibody-mediated rejection with C4d positivity, or
•chronic rejection with C4d positivity (C4d positivity is defined as staining diffuse in peritubular capillary area. Isolated C4d glomerular staining or C4d staining of \< 50% of the peritubular capillaries will not be exclusion criteria). Borderline cellular rejection will not be excluded (Banff 2005), or
•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)

Outcomes

Primary Outcomes

Difference in mean change from screening to 36 months in graft survival and glomerular filtration rates (GFR)

Time Frame: 3 years

Success is defined as: Allograft survival as compared to the performance goal (PG) at 36 months. For the purposes of this study, a graft will be presumed to be lost is when a subject is started on dialysis and is not able to subsequently be removed from dialysis; or a subject's serum creatinine reaches 4.0 mg/dL, is sustained for \>48hours and is not thought to be due to other causes; or the subject is re-transplanted; or the subject dies. AND: A change in extended GFR, defined as \<15% decrease in mean GFR from baseline to 36 months