A Study Designed to Compare the Tolerability of an Increased Dose of Enteric-coated Mycophenolate Acid (MPA) in Renal Transplant Patients Whose Dose of Mycophenolate Mofetil (MMF) Was Reduced Due to Gastrointestinal Symptoms

• Status: Terminated
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion criteria:

• Recipients of first or second cadaveric, living unrelated or living related kidney transplant.

• Patients on a reduced daily dose (500mg to 1500mg) of MMF with existing but tolerable and controlled gastrointestinal symptoms.

• Recipients who are at least 4 weeks post renal transplantation with stable renal function.

Exclusion criteria:

• Multi organ transplant or previous transplant with organ other than kidney

• History of GI disorder prior to transplant

• Evidence of GI disorder induced by infection, underlying medical condition, or con med other than MMF

• Modification of GI med or MMF dose within one week

• Evidence of graft rejection, treatment of acute rejection, unstable renal function within 1 week of (baseline) visit

Other protocol-defined inclusion/exclusion criteria may apply