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

Renal Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00658333
• Other study ID #: CERL080AUS67
• Status: Terminated
• Phase: Phase 4
• First received: January 23, 2008
• Last updated: July 31, 2012
• Start date: March 2008
• Est. completion date: March 2009

Study information

• Verified date: July 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Diseases
• Renal Transplantation
• Signs and Symptoms, Digestive

Intervention

Drug:
• Enteric-coated Mycophenolate Acid (EC-MPA)

• Mycophenolate Mofetil (MMF)

• Placebo MMF

• Placebo EC-MPA

Locations

Country	Name	City	State
United States	Novartis	Aurora	Colorado
United States	Novartis	Baltimore	Maryland
United States	Novartis	Boston	Massachusetts
United States	Novartis	Boston	Massachusetts
United States	Novartis	Burlington	Vermont
United States	Novartis	Charlotte	North Carolina
United States	Novartis	Charlottesville	Virginia
United States	Novartis	Cleveland	Ohio
United States	Novartis	Dallas	Texas
United States	Novarits	Detroit	Michigan
United States	Novartis	Durham	North Carolina
United States	Novarits	Fargo	North Dakota
United States	Novartis	Greenville	North Carolina
United States	Novartis	Houston	Texas
United States	Novartis	Los Angeles	California
United States	Novartis	Los Angeles	California
United States	Novartis	Los Angeles	California
United States	Novartis	Murray	Utah
United States	Novartis	Nashville	Tennessee
United States	Novartis	New Orleans	Louisiana
United States	Novartis	New York	New York
United States	Novartis	New York	New York
United States	Novartis	New York	New York
United States	Novartis	Orange	California
United States	Novartis	Orlando	Florida
United States	Novartis	Philadelphia	Pennsylvania
United States	Novartis	Phoenix	Arizona
United States	Novartis	Portland	Maine
United States	Novartis	Portland	Oregon
United States	Novartis	Portland	Oregon
United States	Novartis	Providence	Rhode Island
United States	Novartis	San Diego	California
United States	Novartis	San Francisco	California
United States	Novartis	Springfield	Massachusetts
United States	Novartis	Temple	Texas
United States	Novartis	Washington	District of Columbia
United States	Novartis	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes