Patient Reported Outcomes in Renal Transplant Patients Tolerating Gastrointestinal (GI) Symptoms Converted to Myfortic (EC-MPS)
Hypothesis: Presently, some patients' mycophenolate mofetil (MMF.,Cellcept) related gastrointestinal (GI) symptoms are not being spontaneously reported. It is postulated that a conversion to enteric-coated mycophenolate sodium (EC-MPS.,Myfortic) from MMF will reduce the objectively measured GI symptom burden and improve GI-related quality of life.
Primary Objective: To determine the incidence of GI-related symptoms and the health related quality of life of renal transplant patients that are currently tolerating MMF. Assessed by GSRS and GIQLI.
Secondary Objective: To determine the impact on GI symptoms and the health related quality of life of renal transplant patients converted from MMF to Myfortic. Assessed by GSRS and GIQLI.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Patient Reported Outcomes in Renal Transplant Patients Tolerating GI Symptoms Converted to Myfortic (EC-MPS).|
- To determine the incidence of GI related symptoms (GSRS) and the health related quality of life (GIQLI) of renal transplant recipients who are currently tolerating or willing to tolerate MMF. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- To determine the impact on GI symptoms and the health related quality of life of renal transplant patients converted from MMF to EC-MPS. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Adverse events. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Renal function as determined by Cockroft-Gault equation. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Routine hematological and biochemical bloodwork changes. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2006|
|Estimated Study Completion Date:||September 2008|
|Estimated Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Mycophenolate Mofetil (Cellcept) discontinued at Baseline visit. Mycophenolate Sodium(Myfortic)commenced the following day at equimolar doses orally BID.
Cellcept 1000mg bid = Myfortic 720mg bid
Investigator originated proposal. Single centre-Foothills Medical Centre, Southern Alberta Transplant Program.
Study design: Three month, longitudinal, open-label, single arm study. Number of study visits: 3 (Baseline, 4-6 weeks, 12 weeks)
Planned sample size :Approx. 110 subjects. Study population will be primary or secondary renal transplant recipients who are stable and are on maintenance immunosuppressive medication which includes MMF.
Gastrointestinal rating scale (GSRS) and Gastrointestinal Quality of Life Index (GIQLI)will be the evaluation tool for GI symptoms, completed by study subject via a "touch screen" pc. at baseline, 4-6 week and final 12 week visit.
Study subjects will discontinue MMF following the evening dose on the day of Baseline visit and commence EC-MPS at equimolar doses of subject's current MMF dose.
At Final study visit (Week 12) study subject will be given the option of continuing on EC-MPS or resuming MMF.
Primary: Incidence of patients tolerating MMF related GI symptoms.
- Patient reported symptoms and quality of life after conversion from MMF to EC-MPS.
- Adverse events.
- Renal function as determined by Cockroft-Gault equation
- Routine hematological and chemistry bloodwork.
Statistical consideration: Descriptive, pair T-Test analysis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676221
|Foothills Medical Centre|
|Calgary, Alberta, Canada, T2N2T9|
|Principal Investigator:||Serdar Yilmaz, MD., PhD||Foothills Medical Centre, Div. of Transplant Surgery|