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

NCT00149968 | Completed Phase 4

• 1 other identifier: CERL080ADE05
• Study Type: interventional
• Target: 196
• Locations: 2 countries
• Sites: 2

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.

Conditions

Renal Transplantation; Gastrointestinal Problems

Keywords

Renal transplantation; MMF; EC-MPS; GI problems

Outcome Measures

Primary Outcomes (1)

• Changes in gastrointestinal symptom severity after conversion from MMF to enteric-coated mycophenolate sodium

  week 0, week 6-8

Secondary Outcomes (2)

• 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

Study Arms (1)

Myfortic

EXPERIMENTAL

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

Interventions

Enteric-Coated Mycophenolate Sodium (EC-MPS) DRUG

Patient on MMF treatment completes questionnaire and switch to equimolar doses of Myfortic. Maximum daily dose 1440 mg

Also known as: Myfortic

Myfortic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (2)

Unknown Facility

Bonn, Germany

Location

Novartis

Basel, Switzerland

Location

Related Publications (2)

• Bolin P, Tanriover B, Zibari GB, Lynn ML, Pirsch JD, Chan L, Cooper M, Langone AJ, Tomlanovich SJ. Improvement in 3-month patient-reported gastrointestinal symptoms after conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in renal transplant patients. Transplantation. 2007 Dec 15;84(11):1443-51. doi: 10.1097/01.tp.0000290678.06523.95.

  PMID: 18091520 BACKGROUND

• Reinke P, Budde K, Hugo C, Petersen P, Schnuelle P, Fricke L, Scholz D, Sperschneider H, Bahner U, Kramer S, Fischer W, Arns W. Reduction of gastrointestinal complications in renal graft recipients after conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium. Transplant Proc. 2011 Jun;43(5):1641-6. doi: 10.1016/j.transproceed.2011.01.184.

  PMID: 21693250 DERIVED

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: April 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: February 11, 2020

Record last verified: 2009-10

Locations

CH (1); DE (1)