NCT00099749

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
255

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

2.4 years

First QC Date

December 17, 2004

Last Update Submit

February 21, 2017

Conditions

Kidney Transplantation

Keywords

Kidney, immunosuppression, transplant, rejection

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

  • 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.

Interventions

FTY 720DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and Female
  • Between 18 to 65 years old

You may not qualify if:

  • Patients in need of multiple organ transplants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

SIU School of Medicine

Springfield, Illinois, 62781, United States

Location

St. Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • Tedesco-Silva H, Szakaly P, Shoker A, Sommerer C, Yoshimura N, Schena FP, Cremer M, Hmissi A, Mayer H, Lang P; FTY720 2218 Clinical Study Group. FTY720 versus mycophenolate mofetil in de novo renal transplantation: six-month results of a double-blind study. Transplantation. 2007 Oct 15;84(7):885-92. doi: 10.1097/01.tp.0000281385.26500.3b.

    PMID: 17984842RESULT

MeSH Terms

Conditions

Rejection, Psychology

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

SphingosineAmino AlcoholsAlcoholsOrganic ChemicalsPropylene GlycolsGlycolsAmines

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2004

First Posted

December 20, 2004

Study Start

November 1, 2003

Primary Completion

April 1, 2006

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

US(5)