Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients

Novartis

Status and phase: Completed; Phase 4

Conditions: De Novo Kidney Transplant Recipients

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00312143

CERL080AEG01

Details and patient eligibility

About

This trial is designed to assess the efficacy, tolerability, and safety of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in kidney transplant recipients.

Enrollment: 35 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Males and females aged 18 to 75 years.
2. Recipients of living related kidney transplant, treated with cyclosporine, with or without corticosteroids, as primary immunosuppression.
3. 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.
4. 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 recipients (e.g. kidney and pancreas) or previous transplant with any organ, other than kidney.
2. Patients with any known hypersensitivity to other components of the formulation (e.g. lactose).
3. Patients with low platelet count (< 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 who have received an investigational drug within four weeks prior to study entry.
5. Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
6. 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.

Additional protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)