Trial · NCT02991768
Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients
NCT02991768, Phase 2, Terminated, University of Kansas Medical Center; results first posted 2024-09-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients. Trials, record NCT02991768. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02991768
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients
- NCT number
- NCT02991768
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- University of Kansas Medical Center
- Conditions
- Diarrhea
- Interventions
- Entocort, Placebos
- First posted
- 2016-12-13
- Last updated
- 2024-09-19
- Results first posted
- 2024-09-19
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Remission of Diarrhea | Week 8 | Measured using symptom diary. Complete remission (CR) is defined as a mean of \<3 stools/day and a mean of \<1 watery stool per day without use of anti-diarrheal drugs. |
| Secondary | Change in Gastrointestinal Symptom Rating Scale (GSRS) | Change from Baseline to Week 8 | GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. The GSRS consists of 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). |
| Secondary | Change in Gastrointestinal Symptom Rating Scale (GSRS) | Change from Baseline to Week 16 | GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. The GSRS consists of 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). |
| Secondary | Change in Gastrointestinal Quality of Life Index (GIQLI) | Change from Baseline to Week 8 | The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI has 5 subscales (GI symptoms, emotional status, physical functions, social functions, and stress of medical treatment), producing a total score of the 36 items. Lower scores represent more dysfunction. |
| Secondary | Change in Gastrointestinal Quality of Life Index (GIQLI) | Change from Baseline to Week 16 | The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI has 5 subscales (GI symptoms, emotional status, physical functions, social functions, and stress of medical treatment), producing a total score of the 36 items. Lower scores represent more dysfunction. |
| Secondary | MPA Dose | Change from Baseline to Week 8 | |
| Secondary | MPA Dose | Change from Baseline to Week 16 |
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 | Complete Remission of Diarrhea | Week 8 | Data not collected. Physician left the institution and study was terminated. | ||
| SECONDARY | Change in Gastrointestinal Symptom Rating Scale (GSRS) | Change from Baseline to Week 8 | Data not collected. Physician left the institution and study was terminated. | ||
| SECONDARY | Change in Gastrointestinal Symptom Rating Scale (GSRS) | Change from Baseline to Week 16 | Data not collected. Physician left the institution and study was terminated. | ||
| SECONDARY | Change in Gastrointestinal Quality of Life Index (GIQLI) | Change from Baseline to Week 8 | Data not collected. Physician left the institution and study was terminated. | ||
| SECONDARY | Change in Gastrointestinal Quality of Life Index (GIQLI) | Change from Baseline to Week 16 | Data not collected. Physician left the institution and study was terminated. | ||
| SECONDARY | MPA Dose | Change from Baseline to Week 8 | Data not collected. Physician left the institution and study was terminated. | ||
| SECONDARY | MPA Dose | Change from Baseline to Week 16 | Data not collected. Physician left the institution and study was terminated. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Entocort EC | 9 | |
| Overall Study | COMPLETED | Entocort EC | 5 | |
| Overall Study | NOT COMPLETED | Entocort EC | 4 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Entocort EC | 0 | 9 |
| Total, other adverse events | Entocort EC | 0 | 9 |
| Total, serious adverse events | Entocort EC | 0 | 9 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02991768
GET https://conductscience.org/api/trials/v1/NCT02991768/registered