Extension Study of the Safety and Efficacy of Enteric-coa... | NCT00241059

Studies
Extension Study of the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients

NCT00241059

Sponsor

Novartis

Status

Completed

Last Update Posted

Jan 31, 2011Estimated

Enrollment

183Actual

Phase

Phase 4

Conditions

Renal Transplantation

Interventions

Enteric-Coated Mycophenolate Sodium (EC-MPS)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2002

Primary Completion Date

Jan 2005Actual

Completion Date

Jan 2005Actual

First Submitted Date

Oct 14, 2005

First Submission Date that Met QC Criteria

Oct 14, 2005

First Posted Date

Oct 18, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2011

Last Update Posted Date

Jan 31, 2011Estimated

Description Module

Brief Summary

The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405LA01) to continue on the same treatment and to assess the long-term safety of EC-MPS.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

183Actual

Label	Type	Description	Intervention Names
EC-MPS arm	Experimental		Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)

Name	Type	Description	Arm Group Labels	Other Names
Enteric-Coated Mycophenolate Sodium (EC-MPS)	Drug		EC-MPS arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety parameters and graft function in maintenance renal transplant recipients.

Secondary Outcomes

Measure	Description	Time Frame
Incidence of acute rejection episodes and graft survival in maintenance renal transplant recipients.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients who completed study CERL080A2405-LA01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.

Exclusion Criteria:

Other protocol-defined inclusion / exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided