NCT00239876

Brief Summary

This study will evaluate the safety and efficacy of FTY720 combined with tacrolimus 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
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

May 1, 2005

Completed
6 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
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Last Updated

November 2, 2011

Status Verified

November 1, 2011

Enrollment Period

7 months

First QC Date

October 13, 2005

Last Update Submit

November 1, 2011

Conditions

Renal Transplantation

Keywords

Transplantation, kidney, and organ transplant

Outcome Measures

Primary Outcomes (8)

  • IA, IB, IIA, IIB, III, or humoral 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, estimated creatinine clearance, assessment of other laboratory abnormalities and vital signs and measurement of urine protein. at Months 18, 24, 30 and 36

  • Pulmonary FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Months 18, 24, 30 and 36

  • Absolute lymphocyte count at Month 18, 24, 30 and 36.

Secondary Outcomes (8)

  • Physical examinations at Months 18, 24, 30 and 36

  • Vital signs at Months 18, 24, 30 and 36

  • Electrocardiogram at Months 24 and 36

  • Chest X-ray Months 24 and 36

  • Safety laboratory tests 18, 24, 30 and 36

  • +3 more secondary outcomes

Interventions

FTY720DRUG

Eligibility Criteria

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

You may qualify if:

  • Completed the 12 month core study

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
NONE
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

May 1, 2005

Primary Completion

December 1, 2005

Last Updated

November 2, 2011

Record last verified: 2011-11