Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients

Two-year Extension of a One-year, Multicenter, Randomized, Partially-blinded Study of the Safety and Efficacy of FTY720 Combined With Corticosteroids and Full or Reduced-dose Cyclosporine, USP [Modified] (Novartis Brand) in de Novo Adult Renal Transplant Recipients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00239902

Enrollment

396

Registered

2005-10-17

Start date

2002-05-31

Completion date

Unknown

Last updated

2011-11-02

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

Conditions

Renal Transplantation

Keywords

Transplantation, kidney, and organ transplantation

Brief summary

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

Interventions

DRUGFTY720

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Inclusion criteria

\- Completion of Core study

Exclusion criteria

Other protocol-defined

Design outcomes

Primary

Measure	Time frame
Discontinuation 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	—
IA, IB, IIA, IIB or III diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant	—

Secondary

Measure	Time frame
Serum creatinine and estimated creatinine clearance within 36 months post transplant	—
Absolute lymphocyte count within 36 months post transplant	—
FEV1 , FVC, DLCO within 36 months post transplant	—

Outcome results

None listed

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