Measurement of Patient Reported Gastrointestinal (GI) and Health-Related Quality of Life (HRQL) Outcomes in Renal Transplant Recipients (MyLife) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 6, 2005

Last Updated Date

April 2, 2009

Start Date ^†

April 2005

Current Primary Outcome Measures ^†

Changes in gastrointestinal symptom severity after conversion from MMF to enteric-coated mycophenolate sodium [ Time Frame: week 0, week 6-8 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00149968 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Gastrointestinal symptoms under MMF-based immunosuppressive therapy [ Time Frame: week 0, week 6-8 ]
Assessment of quality of life, impact of immunosuppressive-induced gastrointestinal symptoms on patient's perception of symptom severity and quality of life [ Time Frame: week 0, week 6-8 ]

Original Secondary Outcome Measures ^†

Gastrointestinal symptoms under MMF-based immunosuppressive therapy; week 0, week 6-8
Assessment of quality of life, impact of immunosuppressive-induced gastrointestinal symptoms on patient’s perception of symptom severity and quality of life; week 0, week 6-8

Descriptive Information

Brief Title ^†

Measurement of Patient Reported Gastrointestinal (GI) and Health-Related Quality of Life (HRQL) Outcomes in Renal Transplant Recipients (MyLife)

Official Title ^†

Measurement of Patient Reported Gastrointestinal (GI) and Health-Related Quality of Life (HRQL) Outcomes in Renal Transplant Recipients (MyLife)

Brief Summary

The purpose of this study is to assess whether a switch from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI- and/or health-related quality of life outcomes, and to determine the proportion of renal transplant recipients who are experiencing any GI complaints under MMF-based immunosuppressive treatment.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

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

Condition ^†

Renal Transplantation
Gastrointestinal Problems

Intervention ^†

Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)

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 ^†

Recruiting

Estimated Enrollment ^†

194

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Received kidney transplant at least 3 months prior to study enrollment
Receiving immunosuppressive regimen that includes MMF in combination with other immunosuppressive drugs
Receiving MMF for at least 1 month prior to enrollment

Exclusion Criteria:

Patients with any known hypersensitivity against mycophenolic acid, mycophenolate sodium, mycophenolate mofetil or other components of the formulations (e.g. lactose; see also summary of product characteristics of EC-MPS)
If applicable, GI symptoms assumed or known not to be caused by MPA therapy (e.g. oral biphosphonates induced, infectious diarrhea)
Acute rejection < 1 week prior to study enrollment

Other protocol-defined inclusion/exclusion criteria may apply.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Novartis

41 61 324 1111

Location Countries ^†

Germany, Switzerland

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00149968

Responsible Party

External Affairs, Novartis Pharmaceuticals

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Investigators ^†

Study Director:

Novartis

Information Provided By

Novartis

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.