Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00149968
First received: September 6, 2005
Last updated: October 14, 2009
Last verified: October 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Measurement of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Renal Transplant Recipients (MyLife)

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Gastrointestinal symptoms under MMF-based immunosuppressive therapy [ Time Frame: week 0, week 6-8 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 196
Study Start Date: April 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Myfortic Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
Patient on MMF treatment completes questionnaire and switch to equimolar doses of Myfortic. Maximum daily dose 1440 mg
Other Name: Myfortic

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Bonn, Germany
Switzerland
Novartis
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00149968     History of Changes
Other Study ID Numbers: CERL080ADE05
Study First Received: September 6, 2005
Last Updated: October 14, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Renal transplantation
MMF
EC-MPS
GI problems

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014