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

Renal Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150020
• Other study ID #: CERL080AUS02
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2005
• Last updated: January 21, 2008
• Start date: October 2004

Study information

• Verified date: January 2008
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 728
• Est. primary completion date: February 2006
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Drug:
• Enteric-coated mycophenolate sodium (EC-MPS)

Locations

Country	Name	City	State
United States	Novartis	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

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