Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients

Diarrhea Clinical Trial

Official title:

Budesonide for Mycophenolic Acid (MPA)-Induced Diarrhea in Renal Transplant Recipients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02991768
• Other study ID #: STUDY00140436
• Status: Terminated
• Phase: Phase 2
• Start date: January 27, 2017
• Est. completion date: April 26, 2019

Study information

• Verified date: May 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: April 26, 2019
• Est. primary completion date: April 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea

Intervention

Drug:
• Entocort
A corticosteroid that decreases levels of inflammatory cytokines.
• Placebos
Placebo is matched to the study drug.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Pooja Budhiraja, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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).	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).	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.	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.	Change from Baseline to Week 16
Secondary	MPA Dose		Change from Baseline to Week 8
Secondary	MPA Dose		Change from Baseline to Week 16