Patient Reported Outcomes in Renal Transplant Patients Tolerating Gastrointestinal (GI) Symptoms Converted to Myfortic (EC-MPS)

Sponsor

Foothills Medical Centre (Other)

Overall Status

Unknown status

CT.gov ID

NCT00676221

Collaborator

Novartis (Industry)

110

Enrollment

Location

26.1

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplant	Drug: Myfortic	Phase 4

Detailed Description

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.

Endpoints:

Primary: Incidence of patients tolerating MMF related GI symptoms.

Secondary:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Patient Reported Outcomes in Renal Transplant Patients Tolerating GI Symptoms Converted to Myfortic (EC-MPS).

Study Start Date :

Jul 1, 2006

Anticipated Primary Completion Date :

Aug 1, 2008

Anticipated Study Completion Date :

Sep 1, 2008

Outcome Measures

Primary Outcome Measures

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. [12 weeks]

Secondary Outcome Measures

To determine the impact on GI symptoms and the health related quality of life of renal transplant patients converted from MMF to EC-MPS. [12 weeks]
Adverse events. [12 weeks]
Renal function as determined by Cockroft-Gault equation. [12 weeks]
Routine hematological and biochemical bloodwork changes. [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Stable primary or secondary renal transplant recipients, males and females. 18-75 years of age.
Stable GFR (>30ml/min) Cockroft-Gault equation at time of last clinic visit and at Screening/Baseline visit.
Immunosuppression drug regimen that includes MMF(Cellcept)for at least 4 weeks prior to study enrollment.
Renal transplant recipients who are tolerating or willing to tolerate GI symptoms related to MMF.
Patients willing and capable of given written informed consent for study participation.

Exclusion Criteria:

Non-stable renal transplant recipients ( infection, thrombocytopenia,neutropenia, anemia, fluctuating GFR, acute rejection < 1 week prior to study enrollment etc.)
Malignancies other than treated basal cell and squamous cell carcinoma of the skin.
Other serious medical conditions ( uncontrolled diabetes, peptic ulcers, etc)
GI symptoms not related to MMF (ie infectious diarrhoea)
Women of childbearing potential who are unwilling to use effective means of contraception.
Presence of psychiatric illness that would interfere with study requ1rements.
Ongoing acute medical intervention or hospitalization.
Patients receiving any investigational drug or having received any investigational drug within 30 days prior to study entry.