- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00529269
Measurement of Patient Reported Outcomes in Korean Renal Transplant Patients With and Without Gastrointestinal (GI) Symptoms
July 5, 2017 updated by: Novartis Pharmaceuticals
Patient Reported Outcomes in Renal Transplant Patients With and Without Gastrointestinal Symptoms
This study will evaluate the impact that GI complaints have on patient-reported outcomes and to determine if there is improvement in patient-reported outcomes when converted from mycophenolate mofetil (MMF) to Enteric-coated mycophenolate sodium (EC-MPS)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Busan, Korea, Republic of
- Novartis Investigative Site
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Seoul, Korea, Republic of
- Novartis Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Received kidney transplant at least 1 month prior to study enrollment
- Receiving immunosuppressive regimen that includes MMF for at least 2 weeks prior to study enrollment
- Eligible to convert to enteric-coated mycophenolate sodium (EC-MPS) because of GI complaints OR not currently experiencing GI complaints and stable on current immunosuppressive regimen
- At least 18 years of age
- Willing to provide written informed consent
- Able to meet all study requirements including completing electronically-administered questionnaires and completing two study visits.
Exclusion Criteria:
- GI symptoms assumed or known not to be caused by MPA (Mycophenolic acid) therapy (e.g. oral biphosphonates induced, infectious diarrhea)
- Acute rejection < 1 week prior to study enrollment
- Woman of child-bearing potential who is planning to become pregnant or is pregnant and/or lactating who is unwilling to use effective means of contraception
- Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements;
- Undergoing acute medical intervention or hospitalization
- Any other medical condition that, in the opinion of the site investigator based on recall or chart review, would interfere with completing the study, including but not limited to, visual problems or cognitive impairment
- Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment.
Other protocol-defined inclusion /exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Symptom severity is assessed by the GSRS (GI Symptom Rating Scale); Health-related Quality of Life (HRQL) is assessed by the GIQLI (GI Quality of Life) Index.
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Secondary Outcome Measures
Outcome Measure |
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Impact of immunosuppressive-induced GI symptoms on patient's perception of symptom severity and HRQL.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Novartis Pharma, Novartis
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
September 11, 2007
First Submitted That Met QC Criteria
September 12, 2007
First Posted (Estimate)
September 14, 2007
Study Record Updates
Last Update Posted (Actual)
July 7, 2017
Last Update Submitted That Met QC Criteria
July 5, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CERL080AKR03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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