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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00658333
First received: January 23, 2008
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Renal Transplantation
Drug: Enteric-coated Mycophenolate Acid (EC-MPA)
Drug: Mycophenolate Mofetil (MMF)
Drug: Placebo MMF
Drug: Placebo EC-MPA
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of Participants With Response (Yes/no) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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:
  • Average Daily Doses (mg) of Enteric-coated Mycophenolate Acid (MPA) and Mycophenolate Mofetil (MMF) by Treatment Duration Intervals [ Time Frame: Baseline and week 4 to week 6 ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 30
Study Start Date: March 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: CellCept®
Drug: Placebo EC-MPA

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658333

  Show 37 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00658333     History of Changes
Other Study ID Numbers: CERL080AUS67
Study First Received: January 23, 2008
Results First Received: December 2, 2010
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Renal Transplantation
Immunosuppression
Renal transplant recipients
Gastrointestinal symptoms associated with MMF therapy

Additional relevant MeSH terms:
Gastrointestinal Diseases
Signs and Symptoms, Digestive
Digestive System Diseases
Signs and Symptoms
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014