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

Phase 4

Completed

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

• Registration Number: NCT00238953
• Lead Sponsor: Novartis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-10-12
• Study First Submitted QC: 2005-10-12
• Study First Posted: 2005-10-14
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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
graft function (serum creatinine, calculated creatinine clearance and glomerular filtration rate),
acute rejection (suspected or biopsy confirmed)
infections, adverse events, serious adverse events.
6 Month evaluation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novartis; 🇨🇭 Basel, Switzerland