Safety and Tolerability of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients With GI Intolerance

Completed · Phase 4

Conditions studied: Renal Transplantation

In brief

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 with mycophenolate mofetil (MMF) and were converted to EC-MPS.

Key facts

Study ID: NCT00150020
Run by: Novartis
People needed: 728
Starts: 2004-10-01
Last updated by the study team: 2008-01-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Novartis — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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