A Study to Investigate the Tolerability and Safety of Con... | NCT00238979

Studies
A Study to Investigate the Tolerability and Safety of Converting Stable Renal Transplant Recipients Who Receive Tacrolimus With or Without Corticosteroids From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)

NCT00238979

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Nov 2, 2011Estimated

Enrollment

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

Status Module

Record Verification Date

Nov 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

Jan 2003

Primary Completion Date

Feb 2005Actual

Completion Date

Not provided

First Submitted Date

Oct 12, 2005

First Submission Date that Met QC Criteria

Oct 12, 2005

First Posted Date

Oct 14, 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

Nov 1, 2011

Last Update Posted Date

Nov 2, 2011Estimated

Description Module

Brief Summary

The aim of this study is whether a switch of stable renal transplant recipients who receive tacrolimus with or without corticosteroids from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) is safe and well tolerated by the patients.

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

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tolerability based on adverse events within 6 months after switch from MMF to an optimized enteric-coated mycophenolate sodium regimen.

Secondary Outcomes

Measure	Description	Time Frame
Safety based on renal function within 6 months after medication switch.
Pharmacokinetics of enteric-coated mycophenolate sodium in combination with tacrolimus in a subpopulation at baseline, week 2, month 3

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Recipients of first or secondary cadaveric heart-beating, living unrelated or living related kidney transplant.
Currently receiving 1, 1.5, or 2 g MMF/day, tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months.
In a stable condition in terms of graft function.

Exclusion criteria:

Patients who had taken an investigational drug within four weeks prior to study entry
History of malignancy within the last 5 years, except excised squamous or basal cell carcinoma of the skin.
Thrombocytopenia (<75,000/mm3), with an absolute neutrophil count of <1,500/mm3 and/or leukocytopenia (<2,500/mm3), and/or hemoglobin <6.0 g/dL prior to enrollment
Clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus, evidence of severe liver disease, HIV or Hepatitis B surface antigen positive.

Other protocol-defined inclusion/exclusion criteria may apply.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis	Novartis	Study Director

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.