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Trial record 42 of 1180 for:    MYCOPHENOLIC ACID

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

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ClinicalTrials.gov Identifier: NCT00658333
Recruitment Status : Terminated
First Posted : April 15, 2008
Results First Posted : March 11, 2011
Last Update Posted : August 7, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE January 23, 2008
First Posted Date  ICMJE April 15, 2008
Results First Submitted Date  ICMJE December 2, 2010
Results First Posted Date  ICMJE March 11, 2011
Last Update Posted Date August 7, 2012
Study Start Date  ICMJE March 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2011)
Number of Participants With Response (Yes/no) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2008)
Conversion and maintenance of an increased dose of enteric coated MPA for 4 weeks in renal transplant patients whose MMF dose had been decreased due to gastrointestinal symptoms [ Time Frame: 2, 4, and 6 weeks ]
Change History Complete list of historical versions of study NCT00658333 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2011)
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 ]
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2008)
Total study drug dose administered at 2, 4 and 6 weeks. [ Time Frame: 2, 4, 6 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Renal Transplantation
Intervention  ICMJE
  • Drug: Enteric-coated Mycophenolate Acid (EC-MPA)
    Other Name: myfortic®
  • Drug: Mycophenolate Mofetil (MMF)
    Other Name: CellCept®
  • Drug: Placebo MMF
  • Drug: Placebo EC-MPA
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Enteric-coated Mycophenolate Acid (EC-MPA)
    • 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.
    Interventions:
    • Drug: Mycophenolate Mofetil (MMF)
    • Drug: Placebo EC-MPA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 15, 2011)
30
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2008)
232
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00658333
Other Study ID Numbers  ICMJE CERL080AUS67
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP