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

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

NCT00238953

CERL080APL01

Details and patient eligibility

About

Clinical trial for the novo transplant recipients, which aims to assess tolerability and safety and clinical outcomes of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in a population of kidney transplant recipients.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and females aged 18 to 75
• Recipients of cadaveric, living unrelated or living related kidney transplant, treated with CsA-ME, with or without corticosteroids, as primary immunosuppression

Exclusion criteria

• Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ, other than kidney.
• Patients with any known hypersensitivity to MPA, EC-MPS or 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 inclusion/exclusion criteria may apply

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

EC MPS

Experimental group

Treatment:

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