Efficacy and Safety of FTY720 Versus Mycophenolate Mofetil (MMF, Roche Brand) in de Novo Adult Renal Transplant Recipients

A Two-year Extension to a One-year, Multicenter, Partially Blinded, Double-dummy, Randomized Study to Evaluate the Efficacy and Safety of FTY720 Combined With Reduced-dose or Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids Versus Mycophenolate Mofetil Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids, in de Novo Adult Renal Transplant Recipients.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00239863

Enrollment

684

Registered

2005-10-17

Start date

2004-05-31

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

Renal Transplantation

Keywords

Transplantation, kidney,organ transplant

Brief summary

This study will evaluate the safety and efficacy of FTY720 versus mycophenolate mofetil (MMF, Roche brand) 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
Absolute lymphocyte count at Month 18, 24, 30 and 36.	—
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, calculated creatinine clearance and urine-protein/creatinine rati at Months 18, 24, 30 and 36 o	—
FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Months 18, 24, 30 and 36	—

Secondary

Measure	Time frame
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	—
Ophthalmic evaluations 18, 24, 30 and 36	—
AEs and SAEs	—
FTY720/CsA levels at Months 18, 24, 30 and 36	—

Outcome results

None listed

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