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

Novartis Pharmaceuticals684 enrolled

Overview

This study will evaluate the 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

DOUBLE

Enrollment

684

Conditions

Renal Transplantation

Interventions

FTY720DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria * Male and female patients of any race between 18 to 65 years old (inclusive) * Patients scheduled to undergo a primary cadaveric or primary non-HLA identical living donor kidney transplantation * Patients who gave written informed consent to participate in the study Exclusion Criteria * Recipients of multi-organ transplantation or foreseen to receive a non-renal allograft during the study period * Graft cold ischemia time greater than 40 hours. * Patients with pulse rate \< 50 beats per minute (bpm) at screening 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 12 months post transplant

Permanent resumption of dialysis within 12 months post transplant

Surgical removal of graft within 12 months post transplant

Death within 12 months post transplant

Withdrawal of consent, death, or lost to follow up within 12 months post transplant

Secondary Outcomes

FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12

Serum creatinine

Cystatin C at months 3, 6, and 12

Proteinuria at day 28, months 6 and 12

Absolute lymphocyte count at screening, baseline, day 1, 7, 14, and 28, months 2, 3, 6, 9, and 12

Data from ClinicalTrials.gov

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