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Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant

Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00099749
Enrollment
255
Registered
2004-12-20
Start date
2003-11-30
Completion date
Unknown
Last updated
2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

Kidney, immunosuppression, transplant, rejection

Brief summary

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

Interventions

DRUGFTY 720

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years

Inclusion criteria

* Male and Female * Between 18 to 65 years old

Exclusion criteria

* Patients in need of multiple organ transplants

Design outcomes

Primary

MeasureTime frame
Biopsy-proven acute rejection (BPAR), graft loss, death and study discontinuation, within 6 months post transplantation.

Secondary

MeasureTime frame
Safety/tolerability based on adverse event reporting.
BPAR, graft loss, death and study discontinuation, within 6 and 12 months post transplantation.
Efficacy parameters between the 3 treatment groups within 6 and 12 months post-transplantation.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026