Clinical trial NCT00149968: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplantation
Gastrointestinal Problems
Keywords: Renal transplantation
MMF
EC-MPS
GI problems
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Changes in gastrointestinal symptom severity after conversion from MMF to enteric-coated mycophenolate sodium
timeFrame: week 0, week 6-8
Secondary outcomes:
measure: Gastrointestinal symptoms under MMF-based immunosuppressive therapy
timeFrame: week 0, week 6-8
measure: Assessment of quality of life, impact of immunosuppressive-induced gastrointestinal symptoms on patient's perception of symptom severity and quality of life
timeFrame: week 0, week 6-8
Other outcomes:
Locations:
city: Bonn
country: Germany
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.