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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00150020

Collaborator

(none)

728

Enrollment

Location

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Renal Transplantation	Drug: Enteric-coated mycophenolate sodium (EC-MPS)	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

728 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Oct 1, 2004

Actual Primary Completion Date :

Feb 1, 2006

Outcome Measures

Primary Outcome Measures

Tolerability of EC-MPS in combination with CsA-ME or tacrolimus as determined by gastrointestinal symptom rating scale (GSRS) after conversion from MMF in maintenance renal transplant patients with GI intolerance [within 3 months]

Secondary Outcome Measures

Safety of EC-MPS in combination with CsA-ME or tacrolimus as determined by incidence and severity of GI adverse events [within 3 months]
Tolerability of EC-MPS in combination with CsA-ME or tacrolimus as determined by gastrointestinal symptom rating scale (GSRS) [within 1 month]
Efficacy of EC-MPS in combination with CsA-ME or tacrolimus as measured by the incidence of biopsy-proven acute rejection [within 3 months]
Tolerability of EC-MPS in combination with CsA-ME or tacrolimus by comparing the two study groups [after 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

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 Criteria:

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.