Status:
COMPLETED
Gastrointestinal and Health-related Quality of Life in Kidney Transplant Patients Treated With Mycophenolate Mofetil
Lead Sponsor:
Novartis
Conditions:
Maintenance Kidney Transplant
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study will assess the quality of life in renal transplant recipients who require a reduced dose of mycophenolate mofetil (MMF) because of gastrointestinal (GI) side effects and will also access t...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Patients who are recipients of a renal transplant.
- Patients treated with an immunosuppressive regiment including MMF before recruitment.
- Patients suffering from GI side effects related to MMF standard doses or patients treated with a reduced MMF dose to control the aforementioned GI side effects.
- Patients 18 years or older.
- Patients who have given written informed consent to participate in the study
- Patients complying with all study requirements including completing questionnaires and attending to the three study visits.
- Exclusion criteria
- Patients with GI symptoms assumed or known not to be caused by MPA therapy (eg. oral bisphosphonate induced, infectious diarrhea)
- Acute rejection less than 1 week before recruitment.
- Females of childbearing potential who are pregnant, planning to get pregnant and/or breast feeding or not willing to practice an approved method of birth control.
- Presence of psychiatric disorder, such as schizophrenia or major depression, in the investigator's opinion, could interfere with study requirements.
- Patients undergoing surgery due to acute illness or hospitalized.
- Existence of any medical condition which, in the investigator's opinion based on anamnesis or medical records, could affect study completion, including but not limiting visual problems or cognitive deterioration.
- Patients currently treated or who have been treated with any other study drug or treatment within 30 days prior to baseline visit.
- Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT00400647
Start Date
July 1 2006
End Date
September 1 2008
Last Update
February 7 2017
Active Locations (1)
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1
Novartis
Basel, Switzerland