Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant

February 21, 2017 updated by: Novartis Pharmaceuticals
The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

255

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Springfield, Illinois, United States, 62781
        • SIU School of Medicine
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • St. Barnabas Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and Female
  • Between 18 to 65 years old

Exclusion Criteria:

  • Patients in need of multiple organ transplants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Biopsy-proven acute rejection (BPAR), graft loss, death and study discontinuation, within 6 months post transplantation.

Secondary Outcome Measures

Outcome Measure
Safety/tolerability based on adverse event reporting.
BPAR, graft loss, death and study discontinuation, within 6 and 12 months post transplantation.
Efficacy parameters between the 3 treatment groups within 6 and 12 months post-transplantation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

December 17, 2004

First Submitted That Met QC Criteria

December 17, 2004

First Posted (Estimate)

December 20, 2004

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFTY720A2218

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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