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

NCT00000935 | Completed Phase 3 DMC

• 1 other identifier: DAIT IG02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to test the clinical and laboratory observations that suggest IVIG given before and after kidney transplant to patients who are sensitized (highly sensitive) to certain transplant antigens could result in reduced sensitization and reduced rates of kidney rejection. Some ESRD patients are highly sensitive to certain transplant antigens (foreign substances that activate the immune system) and must wait for a long time before a well-matched kidney becomes available. Transplant rejection is more likely among highly sensitized patients than in patients who are not highly sensitized. There is no proven method to improve a highly-sensitized patient's chances of receiving and keeping a transplanted kidney.

Conditions

End-Stage Renal Disease; Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• Penalized months of dialysis during the study

  1 year post transplant

Study Arms (2)

Intravenous Immune Globulin (Human)

EXPERIMENTAL

Biological: Intravenous immune globulin (IVIG)

Intravenous Immune Globulin (Human) Placebo

PLACEBO COMPARATOR

Biological: Intravenous immune globulin (IVIG)

Interventions

Intravenous immune globulin (IVIG) BIOLOGICAL

given at a dose of 20mL/kg Intravenous Immune Globulin (Human) (IVIG 10% solvent/detergent)

Intravenous Immune Globulin (Human); Intravenous Immune Globulin (Human) Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Ann Limberger

Rockville, Maryland, 20850, United States

Location

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID)
• Division of Allergy, Immunology, and Transplantation (DAIT)

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Stanley Jordan, MD

  Department of Pediatrics, Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Primary Completion: June 1, 2003
• Study Completion: June 1, 2003
• Last Updated: January 11, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)