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NCT00000935 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of End Stage Renal Disease and Kidney Transplantation, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 3
Development phase
100
Enrollment target
1
Study location

NCT00000935 is a Phase 3 study of End Stage Renal Disease and Kidney Transplantation that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 100 participants, below the 832-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00000935, a Phase 3 study of End Stage Renal Disease and Kidney Transplantation, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 3
Development phase
100 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • BIOLOGICAL Intravenous immune globulin (IVIG)

Study Locations (1)

Maryland

  • Ann Limberger - Rockville

Trial Details

FieldValue
Enrollment Target 100 participants
Est. Completion 2003-06
Phase Phase 3

What the Registry Record Tells You About NCT00000935

The ClinicalTrials.gov registry entry for NCT00000935 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 832-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (88% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with End Stage Renal Disease appearing as the primary indexed condition, and to 1 intervention - of which Intravenous immune globulin (IVIG) is the first listed.

NCT00000935 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00000935 about?

NCT00000935 is a clinical study titled "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". 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 ...

What is the current status of trial NCT00000935?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 100 participants. Estimated completion is 2003-06.

What conditions does trial NCT00000935 study?

This clinical trial studies the following conditions: End Stage Renal Disease, Kidney Transplantation.

What interventions are being tested in trial NCT00000935?

The interventions under investigation include: Intravenous immune globulin (IVIG) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00000935?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00000935 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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