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

NCT ID: NCT00312143

Last Updated: 2011-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2005-10-31

Brief Summary

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.

Conditions

De Novo Kidney Transplant Recipients

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Enteric-coated Mycophenolate sodium (EC-MPS)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Principal Investigators

Novartis

Role: STUDY_DIRECTOR

Novartis

Other Identifiers

CERL080AEG01

Identifier Type: -

Identifier Source: org_study_id