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

A Multicenter, Randomized, Double Blind, Double Dummy Controlled Study to Assess the Tolerability of an Increased Dose of Enteric Coated MPA After Conversion From MMF in Renal Transplant Recipients Who Required MMF Dose Reductions Due to Gastrointestinal Symptoms

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

Study Overview

• Status: Terminated
• Conditions: Renal Transplantation
• Intervention / Treatment: Drug: Mycophenolate Mofetil (MMF); Drug: Enteric-coated Mycophenolate Acid (EC-MPA); Drug: Placebo MMF; Drug: Placebo EC-MPA

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Novartis
  • California
    • Los Angeles, California, United States, 90033
      • Novartis
    • Los Angeles, California, United States, 90057
      • Novartis
    • Los Angeles, California, United States, 90095
      • Novartis
    • Orange, California, United States, 92868
      • Novartis
    • San Diego, California, United States, 92123
      • Novartis
    • San Francisco, California, United States, 94143
      • Novartis
  • Colorado
    • Aurora, Colorado, United States, 80010
      • Novartis
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Novartis
  • Florida
    • Orlando, Florida, United States, 32804
      • Novartis
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Novartis
  • Maine
    • Portland, Maine, United States, 04102
      • Novartis
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Novartis
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Novartis
    • Boston, Massachusetts, United States, 02215
      • Novartis
    • Springfield, Massachusetts, United States, 01107
      • Novartis
  • Michigan
    • Detroit, Michigan, United States, 48236
      • Novarits
  • New York
    • New York, New York, United States, 10032
      • Novartis
    • New York, New York, United States, 10029
      • Novartis
    • New York, New York, United States, 10065
      • Novartis
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Novartis
    • Durham, North Carolina, United States, 27710
      • Novartis
    • Greenville, North Carolina, United States, 27834
      • Novartis
    • Winston-Salem, North Carolina, United States, 27103
      • Novartis
  • North Dakota
    • Fargo, North Dakota, United States, 58123
      • Novarits
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Novartis
  • Oregon
    • Portland, Oregon, United States, 97210
      • Novartis
    • Portland, Oregon, United States, 97239
      • Novartis
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Novartis
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Novartis
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Novartis
  • Texas
    • Dallas, Texas, United States, 75230
      • Novartis
    • Houston, Texas, United States, 77054
      • Novartis
    • Temple, Texas, United States, 76508
      • Novartis
  • Utah
    • Murray, Utah, United States, 84107
      • Novartis
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Novartis
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enteric-coated Mycophenolate Acid; Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.	Drug: Enteric-coated Mycophenolate Acid (EC-MPA); Other Names: myfortic®; Drug: Placebo MMF
Active Comparator: Mycophenolate Mofetil; Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.	Drug: Mycophenolate Mofetil (MMF); Other Names: CellCept®; Drug: Placebo EC-MPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Response (Yes/no)	The primary variable was the response (yes/no) with positive response being defined as an increase of 360 mg/day enteric-coated mycophenolate acid (MPA)from the baseline daily dose, tolerated and maintained for a 4 week duration until the end of the study (Week 6). Tolerability was defined as the overall assessment of improvement or no change in the intensity of physician assessed gastrointestinal (GI) symptoms at end of study as reported on the physician administered evaluation of GI symptomatology.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Daily Doses (mg) of Enteric-coated Mycophenolate Acid (MPA) and Mycophenolate Mofetil (MMF) by Treatment Duration Intervals	The average daily doses of enteric-coated mycophenolate acid (MPA) and mycophenolate mofetil (MMF) at baseline and during the last 2 weeks of treatment. 1000 mg MMF = 720 mg enteric-coated MPA (MPA equivalent dose).	Baseline and week 4 to week 6

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: January 23, 2008
• First Submitted That Met QC Criteria: April 14, 2008
• First Posted (Estimate): April 15, 2008

Study Record Updates

• Last Update Posted (Estimate): August 7, 2012
• Last Update Submitted That Met QC Criteria: July 31, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Immunosuppression; Renal Transplantation; Renal transplant recipients; Gastrointestinal symptoms associated with MMF therapy
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Mycophenolic Acid
• Other Study ID Numbers: CERL080AUS67