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

NCT02115503 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 52

Last updated 2024-02-20

No results posted yet for this study

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.

Conditions

  • Renal Transplant Recipients With Anti-HLA Antibodies

Sponsors & Collaborators

  • Octapharma

    collaborator INDUSTRY

  • Databean

    lead INDUSTRY

Principal Investigators

  • A. O. Gaber, MD · The Methodist Hospital Research Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2019-08-31
Completion
2020-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02115503 on ClinicalTrials.gov