Status:
COMPLETED
Safety and Tolerability of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients With GI Intolerance
Lead Sponsor:
Novartis
Conditions:
Renal Transplantation
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The aim of this study is to evaluate the safety and tolerability of EC-MPS in maintenance renal transplant patients who experience gastrointestinal (GI) intolerance due to adverse events associated wi...
Eligibility Criteria
Inclusion
- Males and females aged 18-75 years.
- Recipients of first or secondary cadaveric, living unrelated or living related kidney transplant.
- Recipients who are at least 4 weeks post renal transplantation.
- Patients currently receiving MMF (all dosages are allowed), cyclosporine microemulsion, its generic equivalent, cyclosporine USP (modified) or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 2 weeks.
- Patients with mild and/or moderate GI complaints (e.g. upper abdominal pain, dyspepsia, anorexia, nausea, vomiting) with or without diarrhea.
Exclusion
- Multi-organ patients (e.g. kidney and pancreas) or previous transplant with any other organ different from kidney (secondary kidney transplant is allowed).
- Evidence of graft rejection, treatment of acute rejection or unstable renal function within 4 weeks prior to baseline visit.
- Patients who have received an investigational immunosuppressive drug within 4 weeks prior to study entry.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
728 Patients enrolled
Trial Details
Trial ID
NCT00150020
Start Date
October 1 2004
Last Update
January 24 2008
Active Locations (1)
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1
Novartis
East Hanover, New Jersey, United States