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Enrollment not continued
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The purpose of this study is to learn if using a Entocort (budesonide) to treat diarrhea will be effective and safe for kidney transplant patients, allowing them to continue with MPA medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entocort EC | Experimental | Subjects will take 6mg Entocort EC by mouth daily for 8 weeks. |
|
| Placebo | Placebo Comparator | Subjects will take 6mg matching placebo pill daily for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entocort | Drug | A corticosteroid that decreases levels of inflammatory cytokines. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission of Diarrhea | 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. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gastrointestinal Symptom Rating Scale (GSRS) | 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). | Change from Baseline to Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pooja Budhiraja, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Entocort EC | Subjects will take 6mg Entocort EC by mouth daily for 8 weeks. Entocort: A corticosteroid that decreases levels of inflammatory cytokines. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entocort EC | Subjects will take 6mg Entocort EC by mouth daily for 8 weeks. Entocort: A corticosteroid that decreases levels of inflammatory cytokines. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Remission of Diarrhea | 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. | Data not collected. Physician left the institution and study was terminated. | Posted | Week 8 |
|
|
Duration of study participation - 16 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Entocort EC | Subjects will take 6mg Entocort EC by mouth daily for 8 weeks. Entocort: A corticosteroid that decreases levels of inflammatory cytokines. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator | University of Kansas Medical Center | 913-588-3520 | edelaney2@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 26, 2018 | Aug 27, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Placebos | Drug | Placebo is matched to the study drug. |
|
| Change in Gastrointestinal Symptom Rating Scale (GSRS) | 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). | Change from Baseline to Week 16 |
| Change in Gastrointestinal Quality of Life Index (GIQLI) | 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. | Change from Baseline to Week 8 |
| Change in Gastrointestinal Quality of Life Index (GIQLI) | 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. | Change from Baseline to Week 16 |
| MPA Dose | Change from Baseline to Week 8 |
| MPA Dose | Change from Baseline to Week 16 |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Secondary | Change in Gastrointestinal Symptom Rating Scale (GSRS) | 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). | Data not collected. Physician left the institution and study was terminated. | Posted | Change from Baseline to Week 8 |
|
|
| Secondary | Change in Gastrointestinal Symptom Rating Scale (GSRS) | 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). | Data not collected. Physician left the institution and study was terminated. | Posted | Change from Baseline to Week 16 |
|
|
| Secondary | Change in Gastrointestinal Quality of Life Index (GIQLI) | 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. | Data not collected. Physician left the institution and study was terminated. | Posted | Change from Baseline to Week 8 |
|
|
| Secondary | Change in Gastrointestinal Quality of Life Index (GIQLI) | 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. | Data not collected. Physician left the institution and study was terminated. | Posted | Change from Baseline to Week 16 |
|
|
| Secondary | MPA Dose | Data not collected. Physician left the institution and study was terminated. | Posted | Change from Baseline to Week 8 |
|
|
| Secondary | MPA Dose | Data not collected. Physician left the institution and study was terminated. | Posted | Change from Baseline to Week 16 |
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |