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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Renal Transplantation

In brief

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

Key facts

Study ID

NCT00658333

Run by

Novartis Pharmaceuticals

People needed

30

Starts

2008-03-01

Expected to finish

2009-03-01

Last updated by the study team

2012-08-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Novartis — Phoenix, Arizona, United States
• Novartis — Los Angeles, California, United States
• Novartis — Los Angeles, California, United States
• Novartis — Los Angeles, California, United States
• Novartis — Orange, California, United States
• Novartis — San Diego, California, United States
• Novartis — San Francisco, California, United States
• Novartis — Aurora, Colorado, United States
• Novartis — Washington D.C., District of Columbia, United States
• Novartis — Orlando, Florida, United States
• Novartis — New Orleans, Louisiana, United States
• Novartis — Portland, Maine, United States
• Novartis — Baltimore, Maryland, United States
• Novartis — Boston, Massachusetts, United States
• Novartis — Boston, Massachusetts, United States
• Novartis — Springfield, Massachusetts, United States
• Novarits — Detroit, Michigan, United States
• Novartis — New York, New York, United States
• Novartis — New York, New York, United States
• Novartis — New York, New York, United States
• Novartis — Charlotte, North Carolina, United States
• Novartis — Durham, North Carolina, United States
• Novartis — Greenville, North Carolina, United States
• Novartis — Winston-Salem, North Carolina, United States
• Novarits — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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