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Study of Intravenous Immunoglobulin (IVIg) Maintenance Therapy in Alloantibody Positive Renal Allograft Recipients

Clinical Trial Details

This is a prospective, multi-center, treatment registry study of patients who are being treated with IVIG as part of clinical care to prevent DSA post-kidney transplant. Renal transplant recipients, who present with donor specific antibodies (DSAmax) with mean fluorescent intensity (MFI) greater than or equal to 1000, and do not have acute rejection, will be enrolled. We therefore theorize that by using monthly low-dose IVIg infusions as a “maintenance immunosuppressant” in DSA-positive kidney transplant recipients the DSAs will be neutralized and allograft survival may be prolonged.

Key eligibility:

  • 18 years of age or older
  • Able to provide voluntary written informed consent
  • Renal transplant recipient at least 1 months 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 above 1000 mean fluorescence intensity (MFI) single antigen bead assay via Luminex (normalized 1,000 and above) measured within 6 months prior to consent
  • Agreeable to receiving IVIg therapy as part of his/her clinical care
  • 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
  • Detailed eligibility provided when you contact the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

Emmanuel Edusei
(212) 746-6112
eme2005@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1405015141

ClinicalTrials.gov:

NCT02115503

Status

Open to Enrollment

Sponsor