Measurement of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Renal Transplant Recipients (MyLife)
NCT ID: NCT00149968
Last Updated: 2020-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
196 participants
INTERVENTIONAL
2005-04-30
2007-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Myfortic
Enteric-Coated Mycophenolate Sodium (EC-MPS)
Patient on MMF treatment completes questionnaire and switch to equimolar doses of Myfortic. Maximum daily dose 1440 mg
Interventions
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Enteric-Coated Mycophenolate Sodium (EC-MPS)
Patient on MMF treatment completes questionnaire and switch to equimolar doses of Myfortic. Maximum daily dose 1440 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receiving immunosuppressive regimen that includes MMF in combination with other immunosuppressive drugs
* Receiving MMF for at least 1 month prior to enrollment
Exclusion Criteria
* If applicable, GI symptoms assumed or known not to be caused by MPA therapy (e.g. oral biphosphonates induced, infectious diarrhea)
* Acute rejection \< 1 week prior to study enrollment
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis
Role: STUDY_DIRECTOR
Novartis
Locations
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Bonn, , Germany
Novartis
Basel, , Switzerland
Countries
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References
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Bolin P, Tanriover B, Zibari GB, Lynn ML, Pirsch JD, Chan L, Cooper M, Langone AJ, Tomlanovich SJ. Improvement in 3-month patient-reported gastrointestinal symptoms after conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in renal transplant patients. Transplantation. 2007 Dec 15;84(11):1443-51. doi: 10.1097/01.tp.0000290678.06523.95.
Reinke P, Budde K, Hugo C, Petersen P, Schnuelle P, Fricke L, Scholz D, Sperschneider H, Bahner U, Kramer S, Fischer W, Arns W. Reduction of gastrointestinal complications in renal graft recipients after conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium. Transplant Proc. 2011 Jun;43(5):1641-6. doi: 10.1016/j.transproceed.2011.01.184.
Other Identifiers
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CERL080ADE05
Identifier Type: -
Identifier Source: org_study_id
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