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

Novartis

Status and phase: Completed; Phase 3

Conditions: Kidney Transplantation

Treatments: Drug: FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids; Drug: FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids; Drug: MMF 2 g + full-dose Neoral (FDN) + corticosteroids

Study type: Interventional

Funder types: Industry

Identifiers

NCT00099736

CFTY720 0125 (Other Identifier)

CFTY7200125 (Other Identifier)

CFTY720A0125

Details and patient eligibility

About

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

Enrollment: 696 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• First kidney transplantation
• Male and female patients
• Between 18 and 65 years old

Exclusion criteria

• Patients in need of multiple organ transplants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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696 participants in 3 patient groups

FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids,

Experimental group

Treatment:

Drug: FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids

FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids

Experimental group

Treatment:

Drug: FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids

MMF 2 g + full-dose Neoral (FDN) + corticosteroids

Experimental group

Treatment:

Drug: MMF 2 g + full-dose Neoral (FDN) + corticosteroids