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

Tracking Information

First Received Date ^ICMJE

January 10, 2007

Last Updated Date

November 19, 2007

Start Date ^ICMJE

March 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Gastrointestinal Quality of Life index, and Gastrointestinal Symptom Rating Scale, at 3 months.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00420472 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open-Label Study to Evaluate the Effect on Quality of Life of Switching Kidney Transplant Patients From Reduced Dose EC-MPS to a Higher Than the Equimolar Dose of CellCept

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Kidney Transplantation

Intervention ^ICMJE

Drug: mycophenolate mofetil [CellCept]

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00420472

Responsible Party

Study ID Numbers ^ICMJE

ML20240

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

Information Provided By

Hoffmann-La Roche

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP