A Study of CellCept (Mycophenolate Mofetil) in Kidney Tra... | NCT00420472

Studies
A Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients Switched From EC-MPS.

NCT00420472

Sponsor

Hoffmann-La Roche

Status

Terminated

Last Update Posted

Nov 20, 2007Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Kidney Transplantation

Interventions

mycophenolate mofetil [CellCept]

Countries

Germany

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

Nov 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jan 10, 2007

First Submission Date that Met QC Criteria

Jan 10, 2007

First Posted Date

Jan 11, 2007Estimated

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 19, 2007

Last Update Posted Date

Nov 20, 2007Estimated

Description Module

Brief Summary

This study will assess the safety, efficacy and effect on quality of life of switching kidney transplant patients from reduced dose EC-MPS treatment due to gastrointestinal problems to a higher than the equimolar dose of CellCept. Patients will be switched, initially, from EC-MPS (<1440g/day) to an equimolar dose of CellCept, and at the next visit (day 10 +/- 5) the CellCept dose will be increased by 250mg/day, and the daily dose will be split into 3-4 doses. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

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

Not provided

Name	Type	Description	Arm Group Labels	Other Names
mycophenolate mofetil [CellCept]	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gastrointestinal Quality of Life index, and Gastrointestinal Symptom Rating Scale, at 3 months.

Secondary Outcomes

Measure	Description	Time Frame
Efficacy: Mean dose increase of CellCept. Pharmacokinetics: Comparison of pharmacokinetic parameters under EC-MPS and CellCept therapy. Safety: AEs; acute rejection episodes.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients, >=18 years of age;
first or second kidney transplant;
EC-MPS therapy for >=6 months, with a stable dose for >=2 months;
lower than recommended dose of EC-MPS (<1440g/day) due to gastrointestinal complaints.

Exclusion Criteria:

patients who have participated in this study before;
patients currently participating in another clinical trial, or who participated in one during the last 30 days.

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

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Intervention Browse Module

MeSH Terms

ID	Term
D009173	Mycophenolic Acid

Ancestor Terms

ID	Term
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Berlin		10117	Germany