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

Phase 4

Completed

• Conditions: Renal Transplantation

• Registration Number: NCT00150020
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Primary Completion: 2006-02
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-21
• Last Update Posted: 2008-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 728

Inclusion Criteria

1. Males and females aged 18-75 years.
2. Recipients of first or secondary cadaveric, living unrelated or living related kidney transplant.
3. Recipients who are at least 4 weeks post renal transplantation.
4. 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.
5. Patients with mild and/or moderate GI complaints (e.g. upper abdominal pain, dyspepsia, anorexia, nausea, vomiting) with or without diarrhea.

Exclusion Criteria

1. Multi-organ patients (e.g. kidney and pancreas) or previous transplant with any other organ different from kidney (secondary kidney transplant is allowed).
2. Evidence of graft rejection, treatment of acute rejection or unstable renal function within 4 weeks prior to baseline visit.
3. Patients who have received an investigational immunosuppressive drug within 4 weeks prior to study entry.

Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States