A Phase 3 interventional study of Enteric-coated mycophenolate sodium in Prevention of Acute Rejection After Kidney Transplantation, sponsored by Novartis. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-02-02.
Sponsored by Novartis · Phase 3, Interventional, and Prevention
The aim of the study is to assess the safety and efficacy of enteric-coated mycophenolate sodium, given in combination with tacrolimus, after equimolar dose conversion from MMF to enteric-coated mycophenolate sodium in stable renal transplant patients.
Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects expected to discontinue tacrolimus therapy;
Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula
Incidence of biopsy proven acute rejection
Overall Gastrointestinal disturbances as measured by visual analog scales (upper and lower gastrointestinal symptoms)
Quality of life related to GI symptoms (GIQLI scale)
Full blood count
Gastrointestinal Adverse Events (check-list)
No study locations are listed for this record.
This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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Novartis