Trial Outcomes & Findings for Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients (NCT NCT02991768)
NCT ID: NCT02991768
Last Updated: 2024-09-19
Results Overview
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.
TERMINATED
PHASE2
9 participants
Week 8
2024-09-19
Participant Flow
Participant milestones
| Measure |
Entocort EC
Subjects will take 6mg Entocort EC by mouth daily for 8 weeks.
Entocort: A corticosteroid that decreases levels of inflammatory cytokines.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Entocort EC
Subjects will take 6mg Entocort EC by mouth daily for 8 weeks.
Entocort: A corticosteroid that decreases levels of inflammatory cytokines.
|
|---|---|
|
Overall Study
Physician Decision
|
4
|
Baseline Characteristics
Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients
Baseline characteristics by cohort
| Measure |
Entocort EC
n=9 Participants
Subjects will take 6mg Entocort EC by mouth daily for 8 weeks.
Entocort: A corticosteroid that decreases levels of inflammatory cytokines.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
48.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Data not collected. Physician left the institution and study was terminated.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline to Week 8Population: Data not collected. Physician left the institution and study was terminated.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline to Week 16Population: Data not collected. Physician left the institution and study was terminated.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline to Week 8Population: Data not collected. Physician left the institution and study was terminated.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline to Week 16Population: Data not collected. Physician left the institution and study was terminated.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline to Week 8Population: Data not collected. Physician left the institution and study was terminated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline to Week 16Population: Data not collected. Physician left the institution and study was terminated.
Outcome measures
Outcome data not reported
Adverse Events
Entocort EC
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Research Coordinator
University of Kansas Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place