Small Bowel Capsule Endoscopy Findings in Patients Receiving Cellcept®

• ClinicalTrials.gov Identifier: NCT00652834
• Recruitment Status: Completed
• First Posted: April 4, 2008
• Results First Posted: March 4, 2016
• Last Update Posted: March 4, 2016
• Sponsor: University of California, Los Angeles
• Collaborator: Novartis
• Information provided by (Responsible Party): Suphamai Bunnapradist, University of California, Los Angeles

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Gastrointestinal Lesions; Signs and Symptoms, Digestive
• Interventions: Procedure: Small bowel capsule endoscopy (SBCE); Drug: myfortic
• Enrollment: 23

Participant Flow

Recruitment Details	Kidney Transplant Clinic
Pre-assignment Details

Arm/Group Title	Kidney Transplant Recipients With GI Symptoms
Arm/Group Description	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.
Period Title: Overall Study
Started	23
Completed	18 [1]
Not Completed	5
Reason Not Completed
Withdrawal by Subject	3
Lost to Follow-up	2
[1] 3 subjects withdrew after completing baseline questionnaire. 2 did not complete 30-day visit.

Baseline Characteristics

Arm/Group Title		Kidney Transplant Recipients With GI Symptoms
Arm/Group Description		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.
Overall Number of Baseline Participants		18
Baseline Analysis Population Description		of 23 participants, 18 participants completed the study.
Age, Continuous; Median (Standard Deviation); Unit of measure: Years
	Number Analyzed	18 participants
		45 (11.69)
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	18 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	17 94.4%
	>=65 years	1 5.6%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	18 participants
	Female	8 44.4%
	Male	10 55.6%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	18 participants
		18

Outcome Measures

1. Primary Outcome

Title	GI Mucosal Lesions Change and Clinical Symptoms Using The Gastrointestinal Symptom Rating Scale (GSRS) Score
Description	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.
Time Frame	one month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Kidney Transplant Recipients With GI Symptoms
Arm/Group Description:	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.
Overall Number of Participants Analyzed	18
Mean (95% Confidence Interval); Unit of Measure: GSRS score
baseline	2.99; (2.18 to 3.80)
day 30	2.19; (1.39 to 2.99)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Kidney Transplant Recipients With GI Symptoms
	Comments	The results of the initial SBCE exams were evaluated by a visually challenged GI specialist who gave us a descriptive report. By the end of the study, we submitted the final reports to the same specialist and asked his impression on the significant changes observed in patients' exams for each GI segment (stomach and small bowel). There were no comparison groups. Each patient is their own control. Given that this is a pilot study there is no power calculation.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.05
	Comments	The p value is only for GSRS score comparison only.
	Method	t-test, 2 sided
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0
	Estimation Comments	The GSRS range is 1-7

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Kidney Transplant Recipients With GI Symptoms
Arm/Group Description	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.
All-Cause Mortality
	Kidney Transplant Recipients With GI Symptoms
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Kidney Transplant Recipients With GI Symptoms
	Affected / at Risk (%)
Total	0/23 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Kidney Transplant Recipients With GI Symptoms
	Affected / at Risk (%)
Total	0/23 (0.00%)

Limitations and Caveats

We did not enroll asymptomatic patients and in the extension of the trial the number of patients re-examined were few and the data obtained from them are not enough to provide definitive information.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Bunnapradist
• Organization: UCLA Kidney Transplant Research Program
• Phone: 310-794-8516
• EMail: bunnapradist@mednet.ucla.edu

Publications of Results:

Bunnapradist S, Sampaio MS, Wilkinson AH, Pham PT, Huang E, Kuo HT, Anastasi B, Danovitch GM, Lo SK. Changes in the small bowel of symptomatic kidney transplant recipients converted from mycophenolate mofetil to enteric-coated mycophenolate sodium. Am J Nephrol. 2014;40(2):184-90. doi: 10.1159/000365360. Epub 2014 Sep 2.

Other Publications:

Shaw LM, Sollinger HW, Halloran P, Morris RE, Yatscoff RW, Ransom J, Tsina I, Keown P, Holt DW, Lieberman R, et al. Mycophenolate mofetil: a report of the consensus panel. Ther Drug Monit. 1995 Dec;17(6):690-9. Review.

Ojo AO, Meier-Kriesche HU, Hanson JA, Leichtman AB, Cibrik D, Magee JC, Wolfe RA, Agodoa LY, Kaplan B. Mycophenolate mofetil reduces late renal allograft loss independent of acute rejection. Transplantation. 2000 Jun 15;69(11):2405-9.

Meier-Kriesche HU, Steffen BJ, Hochberg AM, Gordon RD, Liebman MN, Morris JA, Kaplan B. Long-term use of mycophenolate mofetil is associated with a reduction in the incidence and risk of late rejection. Am J Transplant. 2003 Jan;3(1):68-73.

Behrend M. Adverse gastrointestinal effects of mycophenolate mofetil: aetiology, incidence and management. Drug Saf. 2001;24(9):645-63. Review.

Salvadori M, Holzer H, de Mattos A, Sollinger H, Arns W, Oppenheimer F, Maca J, Hall M; ERL B301 Study Groups. Enteric-coated mycophenolate sodium is therapeutically equivalent to mycophenolate mofetil in de novo renal transplant patients. Am J Transplant. 2004 Feb;4(2):231-6.

Dimenäs E, Carlsson G, Glise H, Israelsson B, Wiklund I. Relevance of norm values as part of the documentation of quality of life instruments for use in upper gastrointestinal disease. Scand J Gastroenterol Suppl. 1996;221:8-13.

Kleinman L, Faull R, Walker R, Ramesh Prasad GV, Ambuehl P, Bahner U. Gastrointestinal-specific patient-reported outcome instruments differentiate between renal transplant patients with or without GI complications. Transplant Proc. 2005 Mar;37(2):846-9.

• Responsible Party: Suphamai Bunnapradist, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT00652834
• Other Study ID Numbers: 11-001911
• First Submitted: April 1, 2008
• First Posted: April 4, 2008
• Results First Submitted: December 2, 2014
• Results First Posted: March 4, 2016
• Last Update Posted: March 4, 2016