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

• Status: Unknown status
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Foothills Medical Centre
• Collaborator: Novartis
• Treatments: Mycophenolate mofetil; Mycophenolic Acid

Criteria

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.