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

A 24-month Extension of a One-year, Multicenter, Double Blinded Double Dummy, Randomized Study to Evaluate the Safety and Efficacy of Two Doses of FTY720 Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Steroids Versus Mycophenolate Mofetil Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Steroids, in Adult de Novo Renal Transplant Recipients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00239798

Enrollment

255

Registered

2005-10-17

Start date

2004-11-30

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

Renal Transplantation

Keywords

Transplantation, kidney, organ transplant

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

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Inclusion criteria

* Patients who have completed the 12 Month visit of the Core trial either on or off study drug. * Female capable of becoming pregnant are required to have a medically approved method of birth control until 3 Month after study medication was stopped.

Exclusion criteria

\- None

Design outcomes

Primary

Measure	Time frame
Absolute lymphocyte count within 36 months post transplant	—
IA, IB, IIA, IIB, III, or humoral acute 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, and estimated creatinine clearance within 36 months post transplant	—
FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% within 36 months post transplant	—

Secondary

Measure	Time frame
IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria at Month 24 and Month 36 post-transplant	—
Permanent resumption of dialysis at Month 24 and Month 36 post-transplant	—
Surgical removal of graft at Month 24 and Month 36 post-transplant	—
Death at Month 24 and Month 36 post-transplant	—
Withdrawal of consent, death, or lost to follow up at Month 24 and Month 36 post-transplant	—
Serum creatinine, and estimated creatinine clearance at Month 24 and Month 36 post-transplant	—
FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Month 24 and Month 36 post-transplant	—
Absolute lymphocyte count at Month 18, 24, 30 and 36	—

Outcome results

None listed

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