NCT00239798

Brief Summary

This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.

Trial Health

100
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

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, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

October 13, 2005

Last Update Submit

February 21, 2017

Conditions

Renal Transplantation

Keywords

Transplantation, kidney, organ transplant

Outcome Measures

Primary Outcomes (8)

  • IA, IB, IIA, IIB, III, or humoral acute rejection diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant

  • Permanent resumption of dialysis within 36 months post transplant

  • Surgical removal of graft within 36 months post transplant

  • Death within 36 months post transplant

  • Withdrawal of consent, death, or lost to follow up within 36 months post transplant

  • Serum creatinine, and estimated creatinine clearance within 36 months post transplant

  • FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% within 36 months post transplant

  • Absolute lymphocyte count within 36 months post transplant

Secondary Outcomes (8)

  • IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria at Month 24 and Month 36 post-transplant

  • Permanent resumption of dialysis at Month 24 and Month 36 post-transplant

  • Surgical removal of graft at Month 24 and Month 36 post-transplant

  • Death at Month 24 and Month 36 post-transplant

  • Withdrawal of consent, death, or lost to follow up at Month 24 and Month 36 post-transplant

  • +3 more secondary outcomes

Interventions

FTY720DRUG

Eligibility Criteria

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

You may qualify if:

  • Patients who have completed the 12 Month visit of the Core trial either on or off study drug.
  • Female capable of becoming pregnant are required to have a medically approved method of birth control until 3 Month after study medication was stopped.

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Interventions

Fingolimod Hydrochloride

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

October 13, 2005

First Posted

October 17, 2005

Study Start

November 1, 2004

Primary Completion

November 1, 2006

Last Updated

February 23, 2017

Record last verified: 2017-02