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NCT00113269 · ClinicalTrials.gov registry record · Phase 4

Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients

A Phase 4 study of Kidney Transplantation, sponsored by Astellas Pharma.

Completed
Registry status
Phase 4
Development phase
501
Enrollment target
20
Study locations

NCT00113269 is a Phase 4 study of Kidney Transplantation that has completed, run by Astellas Pharma. The registered enrollment target is 501 participants, above the 253-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (98% higher). The trial reports 20 study locations across 9 states.

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The verdict

NCT00113269, a Phase 4 study of Kidney Transplantation, has completed, sponsored by Astellas Pharma.

COMPLETED
Registry status
Phase 4
Development phase
501 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.

Conditions Studied

Interventions

  • DRUG tacrolimus
  • DRUG mycophenolate mofetil
  • DRUG alemtuzumab
  • DRUG basiliximab
  • DRUG rabbit anti-thymocyte globulin

Study Locations (20)

California

  • - Los Angeles
  • - Palo Alto
  • - San Diego
  • - San Francisco
  • - San Francisco

New York

  • - Hawthorne
  • - New York
  • - New York

District of Columbia

  • - Washington D.C.
  • - Washington D.C.

Florida

  • - Miami
  • - Tampa

Illinois

  • - Chicago
  • - Chicago

New Jersey

  • - Livingston
  • - New Brunswick

North Carolina

  • - Chapel Hill
  • - Durham

Alabama

  • - Birmingham

Trial Details

FieldValue
Enrollment Target 501 participants
Start Date 2005-05
Est. Completion 2009-03
Phase Phase 4

Sponsor

Astellas Pharma

165 total trials

What the Registry Record Tells You About NCT00113269

The ClinicalTrials.gov registry entry for NCT00113269 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 501 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 253-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (98% higher). The listed sponsor is Astellas Pharma, which has 165 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Kidney Transplantation appearing as the primary indexed condition, and to 5 interventions - of which tacrolimus is the first listed.

NCT00113269 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, New York, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT00113269 about?

NCT00113269 is a clinical study titled "Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients". The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.

What is the current status of trial NCT00113269?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 501 participants. The study started on 2005-05. Estimated completion is 2009-03.

What conditions does trial NCT00113269 study?

This clinical trial studies the following conditions: Kidney Transplantation.

What interventions are being tested in trial NCT00113269?

The interventions under investigation include: tacrolimus (DRUG), mycophenolate mofetil (DRUG), alemtuzumab (DRUG), basiliximab (DRUG), rabbit anti-thymocyte globulin (DRUG).

Who is sponsoring clinical trial NCT00113269?

This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00113269 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. 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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.