NCT00099801

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_3

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

First Submitted

Initial submission to the registry

December 21, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

December 21, 2004

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

June 7, 2017

Status Verified

June 1, 2017

Enrollment Period

1.2 years

First QC Date

December 21, 2004

Last Update Submit

June 5, 2017

Conditions

Kidney Transplantation

Keywords

Kidney, Transplantation, Rejection, Immunosuppression

Interventions

FTY720DRUG

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing their first kidney transplant
  • Male or female age 18 to 65 years

You may not qualify if:

  • Patients in need of second kidney transplant or multi-organ transplants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Saab G, Almony A, Blinder KJ, Schuessler R, Brennan DC. Reversible cystoid macular edema secondary to fingolimod in a renal transplant recipient. Arch Ophthalmol. 2008 Jan;126(1):140-1. doi: 10.1001/archophthalmol.2007.23. No abstract available.

    PMID: 18195237RESULT

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 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 21, 2004

First Posted

December 21, 2004

Study Start

January 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

June 7, 2017

Record last verified: 2017-06