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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00099749

First received: December 17, 2004

Last updated: November 1, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 17, 2004

Last Updated Date

November 1, 2011

Start Date ^ICMJE

November 2003

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

To compare the efficacy and safety of FTY720 in kidney transplantation.

Change History

Complete list of historical versions of study NCT00099749 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Kidney Transplantation

Intervention ^ICMJE

Drug: FTY 720

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

255

Completion Date

Not Provided

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male and Female
Between 18 to 65 years old

Exclusion Criteria:

Patients in need of multiple organ transplants

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00099749

Other Study ID Numbers ^ICMJE

CFTY720A2218

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis

Information Provided By

Novartis

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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