NCT00239785

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
684

participants targeted

Target at P75+ 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, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
7 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
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

October 13, 2005

Last Update Submit

August 18, 2017

Conditions

Renal Transplantation

Keywords

Transplantation, kidney, and organ transplant.

Outcome Measures

Primary Outcomes (5)

  • 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

Secondary Outcomes (5)

  • FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12

  • Serum creatinine

  • Cystatin C at months 3, 6, and 12

  • Proteinuria at day 28, months 6 and 12

  • Absolute lymphocyte count at screening, baseline, day 1, 7, 14, and 28, months 2, 3, 6, 9, and 12

Interventions

FTY720DRUG

Eligibility Criteria

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

You may qualify if:

  • Male and female patients of any race between 18 to 65 years old (inclusive)
  • Patients scheduled to undergo a primary cadaveric or primary non-HLA identical living donor kidney transplantation

You may not qualify if:

  • Recipients of multi-organ transplantation or foreseen to receive a non-renal allograft during the study period
  • Graft cold ischemia time greater than 40 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 3
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

April 1, 2003

Primary Completion

April 1, 2005

Last Updated

August 22, 2017

Record last verified: 2017-08