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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00312143
• Collaborator: (none)
• Enrollment: 35
• Duration (Months): 20

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
De Novo Kidney Transplant Recipients	Drug: Enteric-coated Mycophenolate sodium (EC-MPS)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: 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
• Study Start Date: Feb 1, 2004
• Actual Primary Completion Date: Oct 1, 2005
• Actual Study Completion Date: Oct 1, 2005

Outcome Measures

Primary Outcome Measures

1. patient and graft survival []

2. acute rejection incidence []

3. graft function at 6 months post transplant. []

Secondary Outcome Measures

1. influence of age, gender, and post-transplantation complications on the main clinical outcomes []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Novartis

Investigators

• Study Director: Novartis, Novartis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00312143
• Other Study ID Numbers: CERL080AEG01
• First Posted: Apr 7, 2006
• Last Update Posted: Feb 2, 2011
• Last Verified: Feb 1, 2011

• Keywords provided by , ,: De novo Kidney Transplant recipients, enteric-coated mycophenolate sodium
• Additional relevant MeSH terms: Mycophenolic Acid

Study Results

No Results Posted as of Feb 2, 2011