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

A Prospective, Open Label, Multicenter Study to Assess the Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients

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.

Study Overview

• Status: Completed
• Conditions: De Novo Kidney Transplant Recipients
• Intervention / Treatment: Drug: Enteric-coated Mycophenolate sodium (EC-MPS)

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
patient and graft survival
acute rejection incidence
graft function at 6 months post transplant.

Secondary Outcome Measures

Outcome Measure
influence of age, gender, and post-transplantation complications on the main clinical outcomes

Collaborators and Investigators

• Sponsor: Novartis

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): October 1, 2005
• Study Completion (Actual): October 1, 2005

Study Registration Dates

• First Submitted: April 5, 2006
• First Submitted That Met QC Criteria: April 5, 2006
• First Posted (Estimate): April 7, 2006

Study Record Updates

• Last Update Posted (Estimate): February 2, 2011
• Last Update Submitted That Met QC Criteria: February 1, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: De novo Kidney Transplant recipients, enteric-coated mycophenolate sodium
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Mycophenolic Acid
• Other Study ID Numbers: CERL080AEG01