Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients

Phase 2

Terminated

• Conditions: Diarrhea
• Interventions: Drug: Placebos; Drug: Entocort

• Registration Number: NCT02991768
• Lead Sponsor: Pooja Budhiraja, MD

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-21
• Study First Submitted QC: 2016-12-09
• Study First Posted: 2016-12-13
• Study Start: 2017-01-27
• Primary Completion: 2019-04-26
• Study Completion: 2019-04-26
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-16
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Kidney transplant recipients > 1 months post-transplant,
• No history of chronic diarrhea pre-transplant,
• >3 watery/soft stools after transplant on at least 4 days in the week without anti-diarrheal for at least 2 weeks or using anti-diarrheals for at least 4 days in the week > 2 weeks
• Subjects on at least 180mg twice a day of mycophenolate-sodium or 250 mg twice a day of cellcept

Exclusion Criteria

• Diagnosis of any known colonic diseases (i.e. Crohn's disease, ulcerative colitis, ischemic colitis, Celiac disease), partial colonic resection, small bowel resection, history of cholecystectomy, Irritable Bowel Syndrome, fecal Incontinence, Bacterial overgrowth, infectious diarrhea (c difficle, cryptospora, giardia, isospora, Human Immunodeficiency Virus), Cytomegalovirus colitis
• Subjects with recent acute rejection treated with high dose steroids
• Subjects taking Boswellia serrata extract, over-the-counter herbs, cholestyramine, nonsteroidal salicylates (other than daily ASA)
• Subjects with active malignancy, liver cirrhosis, active peptic ulcer disease, known intolerance or resistance to budesonide, pregnancy, breast-feeding, mental retardation
• Unable to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	Subjects will take 6mg matching placebo pill daily for 8 weeks.
Entocort EC	Entocort	Subjects will take 6mg Entocort EC by mouth daily for 8 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
MPA Dose	Change from Baseline to Week 16

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States