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

Kidney Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00676221
• Other study ID #: E-20097
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 8, 2008
• Last updated: May 14, 2008
• Start date: July 2006
• Est. completion date: September 2008

Study information

• Verified date: May 2008
• Source: Foothills Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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:

1. Patient reported symptoms and quality of life after conversion from MMF to EC-MPS.

2. Adverse events.

3. Renal function as determined by Cockroft-Gault equation

4. Routine hematological and chemistry bloodwork.

Statistical consideration: Descriptive, pair T-Test analysis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: September 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

Drug:
• Myfortic
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

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
Foothills Medical Centre	Novartis

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Adverse events.		12 weeks	Yes
Secondary	Renal function as determined by Cockroft-Gault equation.		12 weeks	Yes
Secondary	Routine hematological and biochemical bloodwork changes.		12 weeks	Yes