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),
6 Month evaluation
acute rejection (suspected or biopsy confirmed)
infections, adverse events, serious adverse events.

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