NCT00098735

Brief Summary

In patients who receive an organ transplant, their body considers this organ as foreign and attempts to destroy it. This is called rejection. All patients who receive an organ transplant, will take a combination of anti-rejection medications. These medications prevent the new organ from being rejected from the body. FTY720 is a new compound that helps prevent organ rejection.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P25-P50 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

Study Start

First participant enrolled

April 1, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

December 7, 2004

Last Update Submit

November 16, 2016

Conditions

Kidney Transplantation

Keywords

Kidney,Transplantation, rejection, immunosuppression

Outcome Measures

Primary Outcomes (5)

  • IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 6 months post transplant

  • Permanent resumption of dialysis within 6 months post transplant

  • Surgical removal of graft within 6 months post transplant

  • Death within 6 months post transplant

  • Withdrawal of consent, death, or lost to follow up within 6 months post transplant

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Interventions

FTY720DRUG

Eligibility Criteria

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

You may qualify if:

  • First kidney transplantation
  • Male and female patients
  • Between 18 and 65 years old

You may not qualify if:

  • Patient in need of multi-organ transplant
  • Patients with history of cardiac arrest
  • Patients with any past or present malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Tedesco-Silva H, Mourad G, Kahan BD, Boira JG, Weimar W, Mulgaonkar S, Nashan B, Madsen S, Charpentier B, Pellet P, Vanrenterghem Y. FTY720, a novel immunomodulator: efficacy and safety results from the first phase 2A study in de novo renal transplantation. Transplantation. 2005 Jun 15;79(11):1553-60.

    PMID: 15940045RESULT

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2004

First Posted

December 8, 2004

Study Start

April 1, 2004

Primary Completion

April 1, 2006

Last Updated

November 18, 2016

Record last verified: 2016-11