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

Novartis Pharmaceuticals684 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

684

Conditions

Renal Transplantation

Interventions

FTY720DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria * Patients who completed the 12 month core study * Patients who gave written informed consent to participate in the study Exclusion Criteria * Not applicable Other protocol-defined exclusion criteria may apply

Outcomes

Primary Outcomes

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 ratio at Months 18, 24, 30 and 36

FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Months 18, 24, 30 and 36

Absolute lymphocyte count at Months 18, 24, 30 and 36.

Secondary Outcomes

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

Data from ClinicalTrials.gov

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