Status:
UNKNOWN
Patient Reported Outcomes in Renal Transplant Patients Tolerating Gastrointestinal (GI) Symptoms Converted to Myfortic (EC-MPS)
Lead Sponsor:
Foothills Medical Centre
Collaborating Sponsors:
Novartis
Conditions:
Kidney Transplant
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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-c...
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 v...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00676221
Start Date
July 1 2006
End Date
September 1 2008
Last Update
May 15 2008
Active Locations (1)
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1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N2T9