Trial · NCT00400400
Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance
NCT00400400, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2011-08-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance. Trials, record NCT00400400. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00400400
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance
- NCT number
- NCT00400400
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 400 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Renal Transplantation
- Interventions
- Enteric-coated mycophenolate sodium (EC-MPS), Mycophenolate mofetil, Placebo to mycophenolate sodium, Placebo to mycophenolate mofetil
- First posted
- 2006-11-16
- Last updated
- 2011-08-15
- Results first posted
- 2011-08-15
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Participants Who Responded to the Conversion to Mycophenolate Sodium (EC-MPS) Therapy | Baseline, Day 30 | Response assessed using the Gastrointestinal Symptom Rating Scale (GSRS), designed to assess common symptoms with gastrointestinal (GI) disorders. The GSRS has 5 subscales (reflux, diarrhea, constipation, abdominal pain and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The total score is an average of scores across all 15 items; a higher score indicates more GI symptoms. Response was defined as Day 30 improvement in the GSRS Total Score (change from baseline) of greater than or equal to 0.3. Minimum score is 1; maximum score is 7. |
| Secondary | Number of Participants With Biopsy-proven Acute Rejection (BPAR) and Treated Acute Rejection (TAR) | 30 days | TAR was defined as an episode of acute rejection that was suspected on clinical grounds and was treated and confirmed by the investigator according to the patient's response to therapy. BPAR was defined a treated acute rejection that was confirmed by biopsy. A graft core biopsy was performed before or within 24 hours of initiation of anti-rejection therapy and was assessed by the pathologist at the center according to the BANFF 1997 criteria. |
| Secondary | Change From Baseline to Day 30 in the Severity of Gastrointestinal Symptoms Overall Total Score | Baseline, Day 30 | The Severity Score for each GI symptom for each participant was calculated based on the physician's evaluation of current GI symptoms recorded at Baseline and Day 30. For each of the 16 individual GI symptoms the severity score ranged from 0 (absent) to 3 (severe). The Overall Total Score is the Mean of severity ratings of the 16 individual symptoms. |
| Secondary | Number of Participants With Reported Dose Changes or Interruption of Study Medication During the 30 Days of Treatment | 30 days | The number of participants with reported dose changes or interruption of study medication during the 30 days of treatment.The most common dose adjustments were dose increases back to baseline levels following a decrease or interruption and decreases due to abnormal laboratory value Adverse Events (leucopenia, thrombocytopenia, neutropenia, or anemia). |
| Secondary | Change From Baseline in Lower and Upper GI Symptom Burden Measured by GI Symptom Rating Scale Score | Baseline, Day 30 | This is reflected by the total score. The total score incorporates lower and upper GI elements. GSRS overall score is the mean of 15 individual GI symptom scores, each rated on a 7- point scale: 1 = no discomfort, 2= minor discomfort, 3 = mild discomfort, 4 = moderate discomfort, 5 = moderately sever discomfort, 6 = severe discomfort and 7 = very severe discomfort. Change from Baseline was calculated using ANCOVA, model includes GSRS, center and treatment group. |
| Secondary | Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment | Baseline to Day 30 | The GSRS has five subscales (reflux, diarrhea, constipation, abdominal pain, indigestion) producing a mean subscale score ranging from 1 (=no discomfort at all) to 7 (very severe discomfort). The mean score at baseline (BL), the mean score at Day 30 and the mean Change from BL to Day 30 is presented for each of the five subscales. |
| Secondary | Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores | Baseline, Day 30 | The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI has 5 different subscales (GI symptoms, emotional status, physical and social functions, and stress of medical treatment) that are rated on a 5-point scale from 0 to 4. The individual scores are summed to produce a total score of the 36 items for a total possible score of 0 to 144. Lower scores represent greater dysfunction. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Participants Who Responded to the Conversion to Mycophenolate Sodium (EC-MPS) Therapy | Baseline, Day 30 | Intention-to-treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. 2 participants in the enteric-coated mycophenolate sodium group were excluded from the analysis because they had no baseline data. | Participants | NUMBER |
| SECONDARY | Number of Participants With Biopsy-proven Acute Rejection (BPAR) and Treated Acute Rejection (TAR) | 30 days | Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug. | Participants | NUMBER |
| SECONDARY | Change From Baseline to Day 30 in the Severity of Gastrointestinal Symptoms Overall Total Score | Baseline, Day 30 | Intention to treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. n in each of the categories is the number of participants with data. | Score on a scale | MEAN |
| SECONDARY | Number of Participants With Reported Dose Changes or Interruption of Study Medication During the 30 Days of Treatment | 30 days | Intention to treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Lower and Upper GI Symptom Burden Measured by GI Symptom Rating Scale Score | Baseline, Day 30 | Intention-to-treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. 2 participants in the enteric-coated mycophenolate sodium group were excluded from the analysis because they had no baseline data. | change in score on a scale | MEAN |
| SECONDARY | Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment | Baseline to Day 30 | Intention-to-treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. 2 participants in the enteric-coated mycophenolate sodium group were excluded from the analysis because they had no baseline data. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores | Baseline, Day 30 | Participants from the Intention-to-treat (ITT) population consisting of all randomized participants who received at least one dose of study drug for whom data was available for analysis. n in each of the categories is the number of participants with data available. | Score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group86
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Participants Who Responded to the Conversion to Mycophenolate Sodium (EC-MPS) Therapy | Enteric-coated Mycophenolate Sodium | Response | 123 | Participants | |
| The Number of Participants Who Responded to the Conversion to Mycophenolate Sodium (EC-MPS) Therapy | Mycophenolate Mofetil | Response | 109 | Participants | |
| The Number of Participants Who Responded to the Conversion to Mycophenolate Sodium (EC-MPS) Therapy | Enteric-coated Mycophenolate Sodium | No Response | 74 | Participants | |
| The Number of Participants Who Responded to the Conversion to Mycophenolate Sodium (EC-MPS) Therapy | Mycophenolate Mofetil | No Response | 88 | Participants | |
| Number of Participants With Biopsy-proven Acute Rejection (BPAR) and Treated Acute Rejection (TAR) | Enteric-coated Mycophenolate Sodium | BPAR | 0 | Participants | |
| Number of Participants With Biopsy-proven Acute Rejection (BPAR) and Treated Acute Rejection (TAR) | Mycophenolate Mofetil | BPAR | 1 | Participants | |
| Number of Participants With Biopsy-proven Acute Rejection (BPAR) and Treated Acute Rejection (TAR) | Enteric-coated Mycophenolate Sodium | TAR | 0 | Participants | |
| Number of Participants With Biopsy-proven Acute Rejection (BPAR) and Treated Acute Rejection (TAR) | Mycophenolate Mofetil | TAR | 1 | Participants | |
| Change From Baseline to Day 30 in the Severity of Gastrointestinal Symptoms Overall Total Score | Enteric-coated Mycophenolate Sodium | Baseline (n= 198,195) | 0.7 | Standard Deviation 0.4 | Score on a scale |
| Change From Baseline to Day 30 in the Severity of Gastrointestinal Symptoms Overall Total Score | Mycophenolate Mofetil | Baseline (n= 198,195) | 0.6 | Standard Deviation 0.4 | Score on a scale |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Enteric-coated Mycophenolate Sodium | 200 | |
| Overall Study | STARTED | Mycophenolate Mofetil | 200 | |
| Overall Study | Intent-to-Treat Population | Enteric-coated Mycophenolate Sodium | 199 | |
| Overall Study | Intent-to-Treat Population | Mycophenolate Mofetil | 197 | |
| Overall Study | COMPLETED | Enteric-coated Mycophenolate Sodium | 186 | |
| Overall Study | COMPLETED | Mycophenolate Mofetil | 185 | |
| Overall Study | NOT COMPLETED | Enteric-coated Mycophenolate Sodium | 14 | |
| Overall Study | NOT COMPLETED | Mycophenolate Mofetil | 15 |
Source ClinicalTrials.gov
Adverse events84
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Enteric-coated Mycophenolate Sodium | 27 | 199 | |
| other | Abdominal distension | Gastrointestinal disorders | Mycophenolate Mofetil | 31 | 197 | |
| other | Abdominal pain lower | Gastrointestinal disorders | Enteric-coated Mycophenolate Sodium | 10 | 199 | |
| other | Abdominal pain lower | Gastrointestinal disorders | Mycophenolate Mofetil | 12 | 197 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Enteric-coated Mycophenolate Sodium | 9 | 199 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Mycophenolate Mofetil | 16 | 197 | |
| other | Constipation | Gastrointestinal disorders | Enteric-coated Mycophenolate Sodium | 7 | 199 | |
| other | Constipation | Gastrointestinal disorders | Mycophenolate Mofetil | 15 | 197 | |
| other | Diarrhoea | Gastrointestinal disorders | Enteric-coated Mycophenolate Sodium | 21 | 199 | |
| other | Diarrhoea | Gastrointestinal disorders | Mycophenolate Mofetil | 17 | 197 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Enteric-coated Mycophenolate Sodium | ||
| Total, all-cause mortality | Mycophenolate Mofetil | ||
| Total, other adverse events | Enteric-coated Mycophenolate Sodium | 75 | 199 |
| Total, other adverse events | Mycophenolate Mofetil | 89 | 197 |
| Total, serious adverse events | Enteric-coated Mycophenolate Sodium | 7 | 199 |
| Total, serious adverse events | Mycophenolate Mofetil | 11 | 197 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00400400
GET https://conductscience.org/api/trials/v1/NCT00400400/results?page=2