An Open Label Study to Evaluate the Tolerability and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion (CsA-ME) in Maintenance Renal Transplant Recipients

Novartis

Status and phase: Completed; Phase 3

Conditions: Kidney Transplant Recipients

Treatments: Drug: Enteric-coated Mycophenolate sodium (EC-MPS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00239044

CERL080A2405NL01

Details and patient eligibility

About

To evaluate whether maintenance renal transplant patients on micophenolate mofetil (MMF) can be safely converted to EC-MPS, based on adverse events and acute rejection within 6 months after switching from MMF to a EC-MPS regimen.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Males and females aged between 18 and 80 years.
2. Recipients of first or secondary cadaveric, living related or unrelated donor kidney transplant at least 6 months after transplantation.
3. Patients currently receiving CsA-ME with MMF , with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months prior to Screening.
4. Patients receiving MMF at reduced dose prior to study entry
5. Patients in a stable condition in terms of graft function (serum creatinine not above 2.3 mg/dL (=204 µmol/L) at screening and at baseline, or not increased by more than 20% at baseline compared to values obtained at screening), no change of immunosuppressive regimen due to graft malfunction, and any known clinically significant physical and/or laboratory changes for at least 2 months prior to enrollment.
6. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to or at screening. Effective contraception must be used during the trial, and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility.
7. Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.

Exclusion Criteria

1. Multi-organ patients (e.g., kidney and pancreas) or previous transplant with any other organ different from kidney (secondary kidney transplant is allowed)
2. Evidence of graft rejection or treatment of acute rejection within two months prior to Screening.
3. Patients with any known hypersensitivity to EC-MPS or other components of the formulation (e.g., lactose)
4. Patients with thrombocytopenia (<75,000/mm3), with an absolute neutrophil count of <1,500/mm3 and/or leukocytopenia (<2,500/mm3), and/or hemoglobin <6.0 g/dL prior to enrollment.
5. Patients who have received an investigational drug within two weeks prior to Screening (i.e., before Day -14 of run-in period).
6. Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
7. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception
8. Presence of clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus that would interfere with the appropriate conduct of the study.
9. Known positive HIV and/or Hepatitis B surface antigen positive.
10. Evidence of drug and/or alcohol abuse.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)