Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients

Phase 4

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)

• Registration Number: NCT00239083
• Lead Sponsor: Novartis

Brief Summary

The aim of MYFORMS is to assess efficacy and safety on clinical outcomes of EC-MPS in combination with Cyclosporine microemulsion (CsA-ME) in kidney transplant recipients.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-10-12
• Study First Submitted QC: 2005-10-12
• Study First Posted: 2005-10-14
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EC-MPS	Enteric-Coated Mycophenolate Sodium (EC-MPS)	-

Primary Outcome Measures

Name	Time	Method
patient and graft survival
acute rejection incidence
graft function
safety

Secondary Outcome Measures

Name	Time	Method
influence of demographic characteristics, transplant-related variables, medical conditions and post-transplantation complications on the main clinical outcomes, according to the immunosuppressive regimen used.

Trial Locations

Locations (1)

Novartis; 🇨🇭 Basel, Switzerland