A Study to Investigate the Tolerability and Safety of Converting Stable Renal Transplant Recipients Who Receive Tacrolimus With or Without Corticosteroids From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)

Novartis

Status and phase

Completed

Phase 4

Conditions

Renal Transplantation

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00238979

CERL080ADE03

Details and patient eligibility

About

The aim of this study is whether a switch of stable renal transplant recipients who receive tacrolimus with or without corticosteroids from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) is safe and well tolerated by the patients.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Recipients of first or secondary cadaveric heart-beating, living unrelated or living related kidney transplant.
Currently receiving 1, 1.5, or 2 g MMF/day, tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months.
In a stable condition in terms of graft function.

Exclusion criteria

Patients who had taken an investigational drug within four weeks prior to study entry
History of malignancy within the last 5 years, except excised squamous or basal cell carcinoma of the skin.
Thrombocytopenia (<75,000/mm3), with an absolute neutrophil count of <1,500/mm3 and/or leukocytopenia (<2,500/mm3), and/or hemoglobin <6.0 g/dL prior to enrollment
Clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus, evidence of severe liver disease, HIV or Hepatitis B surface antigen positive.

Other protocol-defined inclusion/exclusion criteria may apply.