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

This study is currently recruiting participants.

Verified by Novartis, September 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00149968

Purpose

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.

Condition	Intervention	Phase
Renal Transplantation Gastrointestinal Problems	Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)	Phase IV

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Mycophenolate sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Measurement of Patient Reported Gastrointestinal (GI) and Health-Related Quality of Life (HRQL) Outcomes in Renal Transplant Recipients (MyLife)

Further study details as provided by Novartis:

Primary Outcome Measures:

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

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 ]

Estimated Enrollment:	194
Study Start Date:	April 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149968

Contacts

Contact: Novartis

41 61 324 1111

Locations

Germany
	Recruiting
Bonn, Germany
Contact 41 61 324 1111
Switzerland
Novartis	Recruiting
Basel, Switzerland
Contact: Novartis 41 61 324 1111

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

Study ID Numbers:	CERL080ADE05
Study First Received:	September 6, 2005
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00149968
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Renal transplantation
MMF
EC-MPS
GI problems

Study placed in the following topic categories:

Mycophenolate mofetil
Quality of Life

ClinicalTrials.gov processed this record on January 16, 2009