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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 )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Renal Transplantation
Interventions Drug: Enteric-coated Mycophenolate Acid (EC-MPA)
Drug: Mycophenolate Mofetil (MMF)
Drug: Placebo MMF
Drug: Placebo EC-MPA
Enrollment 30
Recruitment Details Subjects were recruited in the US from March 2008 to March 2009.
Pre-assignment Details Patients were screened for eligibility. If eligible, willing to participate and provided informed consent, patients were randomized in a blinded fashion to either an equimolar dose of enteric-coated mycophenolate acid (MPA) or remained on the current dose of mycophenolate mofetil (MMF).
Arm/Group Title Enteric-coated Mycophenolate Acid Mycophenolate Mofetil
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 15 15
Completed 13 14
Not Completed 2 1
Reason Not Completed
Adverse Event             2             1
Arm/Group Title Enteric-coated Mycophenolate Acid Mycophenolate Mofetil Total
Hide Arm/Group Description 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 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. Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
51.3  (12.54) 49.8  (12.45) 50.5  (12.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
8
  53.3%
7
  46.7%
15
  50.0%
Male
7
  46.7%
8
  53.3%
15
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
1.Primary Outcome
Title Number of Participants With Response (Yes/no)
Hide Description 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title Enteric-coated Mycophenolate Acid Mycophenolate Mofetil
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 15 15
Measure Type: Number
Unit of Measure: Participants
Yes 10 9
No 5 6
2.Secondary Outcome
Title Average Daily Doses (mg) of Enteric-coated Mycophenolate Acid (MPA) and Mycophenolate Mofetil (MMF) by Treatment Duration Intervals
Hide Description 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).
Time Frame Baseline and week 4 to week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Enteric-coated Mycophenolate Acid Mycophenolate Mofetil
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: mg
MMF Baseline Dose (n=15, 15) 1033.30  (351.87) 1216.7  (364.33)
Week 4 to Week 6 (n=13, 14) 914.5  (419.85) 1567.6  (442.55)
Time Frame 6 weeks
Adverse Event Reporting Description Safety population
 
Arm/Group Title Enteric-coated Mycophenolate Acid Mycophenolate Mofetil
Hide Arm/Group Description 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 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.
All-Cause Mortality
Enteric-coated Mycophenolate Acid Mycophenolate Mofetil
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Enteric-coated Mycophenolate Acid Mycophenolate Mofetil
Affected / at Risk (%) Affected / at Risk (%)
Total   2/15 (13.33%)   0/15 (0.00%) 
Cardiac disorders     
Cardiac failure congestive  1  1/15 (6.67%)  0/15 (0.00%) 
Investigations     
Blood creatinine increased  1  1/15 (6.67%)  0/15 (0.00%) 
Renal and urinary disorders     
Renal failure acute  1  1/15 (6.67%)  0/15 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Enteric-coated Mycophenolate Acid Mycophenolate Mofetil
Affected / at Risk (%) Affected / at Risk (%)
Total   12/15 (80.00%)   12/15 (80.00%) 
Blood and lymphatic system disorders     
Neutropenia  1  1/15 (6.67%)  0/15 (0.00%) 
Gastrointestinal disorders     
Abdominal distension  1  0/15 (0.00%)  4/15 (26.67%) 
Abdominal pain  1  1/15 (6.67%)  0/15 (0.00%) 
Abdominal pain lower  1  1/15 (6.67%)  2/15 (13.33%) 
Abdominal pain upper  1  1/15 (6.67%)  1/15 (6.67%) 
Constipation  1  1/15 (6.67%)  3/15 (20.00%) 
Defaecation urgency  1  0/15 (0.00%)  1/15 (6.67%) 
Diarrhoea  1  4/15 (26.67%)  4/15 (26.67%) 
Dyspepsia  1  0/15 (0.00%)  4/15 (26.67%) 
Eructation  1  2/15 (13.33%)  3/15 (20.00%) 
Flatulence  1  3/15 (20.00%)  4/15 (26.67%) 
Gastrointestinal disorder  1  3/15 (20.00%)  1/15 (6.67%) 
Gastrooesophageal reflux disease  1  0/15 (0.00%)  4/15 (26.67%) 
Haematochezia  1  0/15 (0.00%)  1/15 (6.67%) 
Haemorrhoids  1  1/15 (6.67%)  0/15 (0.00%) 
Mouth ulceration  1  1/15 (6.67%)  0/15 (0.00%) 
Nausea  1  1/15 (6.67%)  1/15 (6.67%) 
Vomiting  1  0/15 (0.00%)  1/15 (6.67%) 
General disorders     
Chest discomfort  1  1/15 (6.67%)  0/15 (0.00%) 
Chest pain  1  1/15 (6.67%)  0/15 (0.00%) 
Fatigue  1  0/15 (0.00%)  1/15 (6.67%) 
Oedema peripheral  1  0/15 (0.00%)  1/15 (6.67%) 
Immune system disorders     
Seasonal allergy  1  0/15 (0.00%)  1/15 (6.67%) 
Infections and infestations     
Human polyomavirus infection  1  1/15 (6.67%)  0/15 (0.00%) 
Sputum purulent  1  1/15 (6.67%)  0/15 (0.00%) 
Upper respiratory tract infection  1  1/15 (6.67%)  0/15 (0.00%) 
Urinary tract infection  1  1/15 (6.67%)  0/15 (0.00%) 
Injury, poisoning and procedural complications     
Complications of transplant surgery  1  1/15 (6.67%)  0/15 (0.00%) 
Contusion  1  0/15 (0.00%)  1/15 (6.67%) 
Fall  1  0/15 (0.00%)  1/15 (6.67%) 
Investigations     
Eosinophil count increased  1  1/15 (6.67%)  0/15 (0.00%) 
Lymphocyte count decreased  1  1/15 (6.67%)  1/15 (6.67%) 
Weight increased  1  0/15 (0.00%)  1/15 (6.67%) 
Metabolism and nutrition disorders     
Anorexia  1  1/15 (6.67%)  0/15 (0.00%) 
Decreased appetite  1  0/15 (0.00%)  1/15 (6.67%) 
Hyperuricaemia  1  1/15 (6.67%)  0/15 (0.00%) 
Hypomagnesaemia  1  0/15 (0.00%)  1/15 (6.67%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/15 (6.67%)  1/15 (6.67%) 
Back pain  1  1/15 (6.67%)  0/15 (0.00%) 
Osteopenia  1  1/15 (6.67%)  0/15 (0.00%) 
Pain in extremity  1  0/15 (0.00%)  1/15 (6.67%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/15 (6.67%)  0/15 (0.00%) 
Dyspnoea  1  1/15 (6.67%)  1/15 (6.67%) 
Pleural effusion  1  1/15 (6.67%)  0/15 (0.00%) 
Pulmonary oedema  1  1/15 (6.67%)  0/15 (0.00%) 
Rhinorrhoea  1  1/15 (6.67%)  0/15 (0.00%) 
Skin and subcutaneous tissue disorders     
Night sweats  1  0/15 (0.00%)  1/15 (6.67%) 
Pruritus  1  1/15 (6.67%)  0/15 (0.00%) 
Vascular disorders     
Hypertension  1  0/15 (0.00%)  1/15 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Due to the insufficient number of patients enrolled in the study, no conclusions can be made from the data.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00658333     History of Changes
Other Study ID Numbers: CERL080AUS67
First Submitted: January 23, 2008
First Posted: April 15, 2008
Results First Submitted: December 2, 2010
Results First Posted: March 11, 2011
Last Update Posted: August 7, 2012