Trial Outcomes & Findings for Small Bowel Capsule Endoscopy Findings in Patients Receiving Cellcept® (NCT NCT00652834)

Results Overview

The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. A higher GSRS indicate worse symptoms and a difference between D30 and last SBCE scores greater or equal to 0.3 can be considered as a clinically significant improvement in the symptoms.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

23 participants

Primary outcome timeframe

one month

Results posted on

2016-03-04

Participant Flow

Kidney Transplant Clinic

Participant milestones

Participant milestones
Measure	Kidney Transplant Recipients With GI Symptoms Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30. Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2.
Overall Study STARTED	23
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Kidney Transplant Recipients With GI Symptoms Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30. Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2.
Overall Study Withdrawal by Subject	3
Overall Study Lost to Follow-up	2

Baseline Characteristics

Small Bowel Capsule Endoscopy Findings in Patients Receiving Cellcept®

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Kidney Transplant Recipients With GI Symptoms n=18 Participants If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE. Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30. Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2.
Age, Continuous	45 years STANDARD_DEVIATION 11.69 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: one month

The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. A higher GSRS indicate worse symptoms and a difference between D30 and last SBCE scores greater or equal to 0.3 can be considered as a clinically significant improvement in the symptoms.

Outcome measures

Outcome measures
Measure	Kidney Transplant Recipients With GI Symptoms n=18 Participants If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE. Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30. Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2.
GI Mucosal Lesions Change and Clinical Symptoms Using The Gastrointestinal Symptom Rating Scale (GSRS) Score baseline	2.99 GSRS score Interval 2.18 to 3.8
GI Mucosal Lesions Change and Clinical Symptoms Using The Gastrointestinal Symptom Rating Scale (GSRS) Score day 30	2.19 GSRS score Interval 1.39 to 2.99

Adverse Events

Kidney Transplant Recipients With GI Symptoms

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bunnapradist

UCLA Kidney Transplant Research Program

Phone: 310-794-8516

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place