Renal Transplantation
Conditions
Keywords
Renal/Kidney, Transplantation, MPA, EC-MPS, Renal Transplantation Patients with GI Intolerance with MMF
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.
Interventions
DRUGEnteric-coated mycophenolate sodium (EC-MPS)
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed