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

Novartis30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Renal Transplantation

Interventions

Enteric-Coated Mycophenolate Sodium (EC-MPS)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis

Basel, Switzerland

Outcomes

Primary Outcomes

6 Month evaluation

patient and graft survival

acute rejection (suspected or biopsy confirmed)

graft function (serum creatinine, calculated creatinine clearance and glomerular filtration rate),

infections, adverse events, serious adverse events.

Secondary Outcomes

Influence of parameters: demography, medical conditions, complications post transplantation on main clinical outcomes. 6 month evaluation

Data from ClinicalTrials.gov

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