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

Phase 4

Terminated

• Conditions: Renal Transplantation
• Interventions: Drug: Mycophenolate Mofetil (MMF); Drug: Enteric-coated Mycophenolate Acid (EC-MPA); Drug: Placebo MMF; Drug: Placebo EC-MPA

• Registration Number: NCT00658333
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-23
• Study Start: 2008-03
• Study First Submitted QC: 2008-04-14
• Study First Posted: 2008-04-15
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2010-12-02
• Results First Submitted QC: 2011-02-15
• Results First Posted: 2011-03-11
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-31
• Last Update Posted: 2012-08-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enteric-coated Mycophenolate Acid	Placebo MMF	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.
Mycophenolate Mofetil	Mycophenolate Mofetil (MMF)	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.
Mycophenolate Mofetil	Placebo EC-MPA	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.
Enteric-coated Mycophenolate Acid	Enteric-coated Mycophenolate Acid (EC-MPA)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Response (Yes/no)	6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Average Daily Doses (mg) of Enteric-coated Mycophenolate Acid (MPA) and Mycophenolate Mofetil (MMF) by Treatment Duration Intervals	Baseline and week 4 to week 6	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).

Trial Locations

Locations (2)

Novarits; 🇺🇸 Fargo, North Dakota, United States

Novartis; 🇺🇸 Charlottesville, Virginia, United States