Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients

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

NCT00239083

CERL080ATR01

Details and patient eligibility

About

The aim of MYFORMS is to assess efficacy and safety on clinical outcomes of EC-MPS in combination with Cyclosporine microemulsion (CsA-ME) in kidney transplant recipients.

Enrollment: 40 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

De Novo-Inclusion criteria

1. Males and females aged 6 years or over.
2. Recipients of cadaveric, living unrelated or living related kidney transplant, treated with CsA-Me, with or without corticosteroids, as primary immunosuppression.

Maintenance-Inclusion criteria

1. Males and females aged 6 years or over.
2. Recipients of first or secondary cadaveric, living related or unrelated donor kidney transplant.
3. Patients currently receiving CsA-ME with or without Mycophenolate mofetil (MMF) or azathioprine, with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months prior to Screening.
4. 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 immune suppressive regimen due to graft malfunction, and any known clinically significant physical and/or laboratory changes for at least 2 months prior to enrollment.

De Novo and Maintenance-Exclusion Criteria

1. Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney.
2. Patients with any known hypersensitivity to MPA, EC-MPS or other components of the formulation (e.g. lactose).
3. 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.
4. Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

EC-MPS

Experimental group

Treatment:

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