Clinical Study to Evaluate the Tolerability, Safety and E... | NCT00171392

Studies
Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium, After Equimolar Conversion From Mycophenolate Mofetil (MMF), in Patients With Stable Renal Transplant Receiving Tacrolimus

NCT00171392

Sponsor

Novartis

Status

Completed

Last Update Posted

Feb 2, 2011Estimated

Enrollment

132Actual

Phase

Phase 3

Conditions

Prevention of Acute Rejection After Kidney Transplantation

Interventions

Enteric-coated mycophenolate sodium

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

Feb 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

Mar 2004

Primary Completion Date

Jun 2005Actual

Completion Date

Jun 2005Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 15, 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

Feb 1, 2011

Last Update Posted Date

Feb 2, 2011Estimated

Description Module

Brief Summary

The aim of the study is to assess the safety and efficacy of enteric-coated mycophenolate sodium, given in combination with tacrolimus, after equimolar dose conversion from MMF to enteric-coated mycophenolate sodium in stable renal transplant 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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

132Actual

Name	Type	Description	Arm Group Labels	Other Names
Enteric-coated mycophenolate sodium	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula

Secondary Outcomes

Measure	Description	Time Frame
Incidence of biopsy proven acute rejection
Overall Gastrointestinal disturbances as measured by visual analog scales (upper and lower gastrointestinal symptoms)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

First or second (single or double) deceased or living donor kidney/kidney-pancreas transplant received at least six months previously;
Immunosuppressive therapy with tacrolimus and mycophenolate mofetil (MMF);

Exclusion Criteria:

Subjects expected to discontinue tacrolimus therapy;

Patients with thrombocytopenia (<75,000/mm3), an absolute neutrophil count of <1,500/mm3 and/or leukopenia (<2,500/mm3), or anemia (hemoglobin <6 g/dl) at baseline;
Patients experiencing an acute rejection in the previous two months, with inadequate (creatininemia >2.5 mg/dL) or worsening renal function in the previous two months.

Accepts Healthy Volunteers

Not provided

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

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.