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

August 17, 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 (Actual)

696

Phase

  • 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
    • Arizona
      • Phoenix, Arizona, United States, 85054
    • California
      • Los Angeles, California, United States, 90057
      • Palo Alto, California, United States, 94303
      • San Francisco, California, United States, 94143
    • Colorado
      • Denver, Colorado, United States, 80262
    • Connecticut
      • New Haven, Connecticut, United States, 06520
    • Florida
      • Tampa, Florida, United States, 33606
    • Georgia
      • Atlanta, Georgia, United States, 30322
      • Atlanta, Georgia, United States, 30309
      • Augusta, Georgia, United States, 30912
    • Illinois
      • Chicago, Illinois, United States, 60612
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Iowa
      • Des Moines, Iowa, United States, 50309
    • Maine
      • Portland, Maine, United States, 04102
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
      • Boston, Massachusetts, United States, 02111
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
      • Detroit, Michigan, United States, 48202
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
      • Rochester, Minnesota, United States, 55905
    • Nebraska
      • Omaha, Nebraska, United States, 68198
    • New Jersey
      • Livingston, New Jersey, United States, 07039
    • New York
      • Hawthorne, New York, United States, 10523
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
      • Durham, North Carolina, United States, 27710
    • Ohio
      • Cleveland, Ohio, United States, 44195
      • Cleveland, Ohio, United States, 44106
      • Toledo, Ohio, United States, 43614
    • Oregon
      • Portland, Oregon, United States, 97232
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Tennessee
      • Memphis, Tennessee, United States, 38103
      • Nashville, Tennessee, United States, 37212
    • Texas
      • Dallas, Texas, United States, 75246
      • Galveston, Texas, United States, 77555
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78229
    • Utah
      • Salt Lake City, Utah, United States, 84132
    • Virginia
      • Fairfax, Virginia, United States, 22042
      • Richmond, Virginia, United States, 23298
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
      • Milwaukee, Wisconsin, United States, 53226

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • First kidney transplantation
  • Male and female patients
  • Between 18 and 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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids,
Drug: FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids
FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids
Experimental: FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
Drug: FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
Experimental: MMF 2 g + full-dose Neoral (FDN) + corticosteroids
Drug: MMF 2 g + full-dose Neoral (FDN) + corticosteroids
mycophenolate mofetil (MMF) + full-dose Neoral (FDN) + corticosteroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant
permanent resumption of dialysis within 12 months post transplant
surgical removal of graft within 12 months post transplant
death within 12 months post transplant
withdrawal of consent, death, or lost to follow up within 12 months post transplant

Secondary Outcome Measures

Outcome Measure
serum creatinine
FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12
cystatin C at months 3, 6, and 12
proteinuria at day 28, months 6 and 12
absolute lymphocyte count at screening, baseline, day 1, 7, 14, and 28, months 2, 3, 6, 9, and 12

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

May 7, 2003

Primary Completion (Actual)

September 19, 2005

Study Completion (Actual)

September 19, 2005

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)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 17, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFTY720A0125
  • CFTY720 0125 (Other Identifier: Sponsor)
  • CFTY7200125 (Other Identifier: Sponsor)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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