A One-year, Open Label Study to Investigate the Safety and the Effect of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion in de Novo Kidney Transplant Recipients.

Novartis

Status and phase

Completed

Phase 4

Conditions

Kidney Transplantation

Treatments

Drug: Enteric-Coated Mycophenolate sodium (EC-MPS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00154245

CERL080ATW01

Details and patient eligibility

About

The study is a one-year prospective, open-label, safety and efficacy study. De novo renal transplant recipients will be receiving cyclosporine, 1.44g EC-MPS (720 mg b.i.d.), and corticosteroids .The study will consist of a 12-month open-label treatment period on EC-MPS.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males and females aged 18-75 years. Recipients of de novo cadaveric, living unrelated or living related kidney transplants

Exclusion criteria

Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ.

Patients who are recipients of A-B-O incompatible transplants. Patients with a historical or current peak PRA of 50%. Patients with already existing antibodies against the HLA-type of the receiving transplant.

Evidence of severe liver disease (incl. abnormal liver profile i.e. AST, ALT or total bilirubin 3 times UNL).

Patients who are HIV or Hepatitis B surface antigen positive. Patients with any known hypersensitivity to mycophenolic acid, MMF, EC-MPS, other components of the formulation (e.g. lactose).

Patients with thrombocytopenia (75,000/mm3), with an absolute neutrophil count of < 1,500/mm3, and/or leukocytopenia (< 2,500/mm3), and/or hemoglobin < 6 g/dL at Screening or Baseline.

Other protocol-defined inclusion/exclusion criteria may apply.