Trial Outcomes & Findings for 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 (NCT NCT00658333)
NCT ID: NCT00658333
Last Updated: 2012-08-07
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
6 weeks
Results posted on
2012-08-07
Participant Flow
Subjects were recruited in the US from March 2008 to March 2009.
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).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Enteric-coated Mycophenolate Acid
n=15 Participants
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
n=15 Participants
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
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
51.3 years
STANDARD_DEVIATION 12.54 • n=93 Participants
|
49.8 years
STANDARD_DEVIATION 12.45 • n=4 Participants
|
50.5 years
STANDARD_DEVIATION 12.30 • n=27 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=93 Participants
|
15 participants
n=4 Participants
|
30 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Intent to Treat Population
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.
Outcome measures
| Measure |
Enteric-coated Mycophenolate Acid
n=15 Participants
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
n=15 Participants
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.
|
|---|---|---|
|
Number of Participants With Response (Yes/no)
Yes
|
10 Participants
|
9 Participants
|
|
Number of Participants With Response (Yes/no)
No
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline and week 4 to week 6Population: Safety Population
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).
Outcome measures
| Measure |
Enteric-coated Mycophenolate Acid
n=15 Participants
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
n=15 Participants
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.
|
|---|---|---|
|
Average Daily Doses (mg) of Enteric-coated Mycophenolate Acid (MPA) and Mycophenolate Mofetil (MMF) by Treatment Duration Intervals
MMF Baseline Dose (n=15, 15)
|
1033.30 mg
Standard Deviation 351.87
|
1216.7 mg
Standard Deviation 364.33
|
|
Average Daily Doses (mg) of Enteric-coated Mycophenolate Acid (MPA) and Mycophenolate Mofetil (MMF) by Treatment Duration Intervals
Week 4 to Week 6 (n=13, 14)
|
914.5 mg
Standard Deviation 419.85
|
1567.6 mg
Standard Deviation 442.55
|
Adverse Events
Enteric-coated Mycophenolate Acid
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Mycophenolate Mofetil
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enteric-coated Mycophenolate Acid
n=15 participants at risk
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
n=15 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
Investigations
Blood creatinine increased
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
Renal and urinary disorders
Renal failure acute
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
Other adverse events
| Measure |
Enteric-coated Mycophenolate Acid
n=15 participants at risk
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
n=15 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/15 • 6 weeks
Safety population
|
26.7%
4/15 • 6 weeks
Safety population
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
Gastrointestinal disorders
Abdominal pain lower
|
6.7%
1/15 • 6 weeks
Safety population
|
13.3%
2/15 • 6 weeks
Safety population
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
1/15 • 6 weeks
Safety population
|
6.7%
1/15 • 6 weeks
Safety population
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • 6 weeks
Safety population
|
20.0%
3/15 • 6 weeks
Safety population
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/15 • 6 weeks
Safety population
|
6.7%
1/15 • 6 weeks
Safety population
|
|
Gastrointestinal disorders
Diarrhoea
|
26.7%
4/15 • 6 weeks
Safety population
|
26.7%
4/15 • 6 weeks
Safety population
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15 • 6 weeks
Safety population
|
26.7%
4/15 • 6 weeks
Safety population
|
|
Gastrointestinal disorders
Eructation
|
13.3%
2/15 • 6 weeks
Safety population
|
20.0%
3/15 • 6 weeks
Safety population
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
3/15 • 6 weeks
Safety population
|
26.7%
4/15 • 6 weeks
Safety population
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
20.0%
3/15 • 6 weeks
Safety population
|
6.7%
1/15 • 6 weeks
Safety population
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/15 • 6 weeks
Safety population
|
26.7%
4/15 • 6 weeks
Safety population
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/15 • 6 weeks
Safety population
|
6.7%
1/15 • 6 weeks
Safety population
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • 6 weeks
Safety population
|
6.7%
1/15 • 6 weeks
Safety population
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • 6 weeks
Safety population
|
6.7%
1/15 • 6 weeks
Safety population
|
|
General disorders
Chest discomfort
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
General disorders
Chest pain
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
General disorders
Fatigue
|
0.00%
0/15 • 6 weeks
Safety population
|
6.7%
1/15 • 6 weeks
Safety population
|
|
General disorders
Oedema peripheral
|
0.00%
0/15 • 6 weeks
Safety population
|
6.7%
1/15 • 6 weeks
Safety population
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/15 • 6 weeks
Safety population
|
6.7%
1/15 • 6 weeks
Safety population
|
|
Infections and infestations
Human polyomavirus infection
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
Infections and infestations
Sputum purulent
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
Infections and infestations
Urinary tract infection
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
Injury, poisoning and procedural complications
Complications of transplant surgery
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/15 • 6 weeks
Safety population
|
6.7%
1/15 • 6 weeks
Safety population
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/15 • 6 weeks
Safety population
|
6.7%
1/15 • 6 weeks
Safety population
|
|
Investigations
Eosinophil count increased
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
Investigations
Lymphocyte count decreased
|
6.7%
1/15 • 6 weeks
Safety population
|
6.7%
1/15 • 6 weeks
Safety population
|
|
Investigations
Weight increased
|
0.00%
0/15 • 6 weeks
Safety population
|
6.7%
1/15 • 6 weeks
Safety population
|
|
Metabolism and nutrition disorders
Anorexia
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/15 • 6 weeks
Safety population
|
6.7%
1/15 • 6 weeks
Safety population
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/15 • 6 weeks
Safety population
|
6.7%
1/15 • 6 weeks
Safety population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • 6 weeks
Safety population
|
6.7%
1/15 • 6 weeks
Safety population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • 6 weeks
Safety population
|
6.7%
1/15 • 6 weeks
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
1/15 • 6 weeks
Safety population
|
6.7%
1/15 • 6 weeks
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/15 • 6 weeks
Safety population
|
6.7%
1/15 • 6 weeks
Safety population
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • 6 weeks
Safety population
|
0.00%
0/15 • 6 weeks
Safety population
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • 6 weeks
Safety population
|
6.7%
1/15 • 6 weeks
Safety population
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER