drugset / Trial / NCT00400400

Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance

NCT00400400

Phase 4 Completed 400 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will investigate the safety and tolerability of converting kidney transplant recipients with gastrointestinal symptoms from their current treatment of mycophenolate mofetil (MMF) to treatment with enteric-coated mycophenolate sodium (EC-MPS).

Timeline

Start
2006-10
Primary completion
2008-06
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mycophenolate Mofetil Small molecule 250 mg Oral
Subject Mycophenolate Sodium Unknown 180 mg Oral

Indications

No indication recorded.