Search / Trial NCT00000935

An Evaluation of IV Gamma Globulin As a Method to Improve Kidney Transplant Survival in Patients With End-Stage Renal Disease Who Are Highly Sensitized to Transplant Antigens

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of July 23, 2024

Completed

Keywords

Description

Kidney transplantation is the treatment of choice for patients with end-stage renal disease (ESRD). However, many patients do not receive this treatment due to immune sensitization to HLA antigens. IVIG has been shown to somewhat reduce anti-HLA antibody activity. By blocking this activity, IVIG may make transplants more feasible and increase graft survival in transplant recipients. Patients are randomized to receive IV infusion of either 2 g/kg (maximum dose 180 g) IVIG 10% S/D (Gamimune-N, 10%, manufactured by Bayer) or placebo (0.1% human albumin, manufactured by Bayer) at time of dialy...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • You may be eligible for this study if you:
  • Are 12 years of age or older.
  • Have end-stage renal disease.
  • Currently receive either hemo- or peritoneal dialysis.
  • Have an elevated (> 50%) level of panel reactive antibodies (PRA level) on 3 consecutive monthly tests.
  • Agree to practice sexual abstinence or to use effective means of birth control/contraception during the study and for 1 year after.
  • Exclusion Criteria
  • You will not be eligible for this study if you:
  • Have received IVIG for any reason within 6 months prior to enrollment.
  • Are HIV positive.
  • Are Hepatitis B e-antigen/hepatitis B viral DNA-positive.
  • Have selective IgA deficiency or have known antibodies to IgA.
  • Are allergic to human immune globulin.
  • Are pregnant or breast-feeding.

Attachments

readout_NCT00000935_2024-07-23.pdf

4.5 MB

NCT00000935_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Rockville, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

1 year post transplant

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
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1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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