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Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients

Primary Purpose

Diarrhea

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Entocort
Placebos
Sponsored by
Pooja Budhiraja, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Entocort EC

Placebo

Arm Description

Subjects will take 6mg Entocort EC by mouth daily for 8 weeks.

Subjects will take 6mg matching placebo pill daily for 8 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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 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 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.
MPA Dose
MPA Dose

Full Information

First Posted
November 21, 2016
Last Updated
May 16, 2019
Sponsor
Pooja Budhiraja, MD
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1. Study Identification

Unique Protocol Identification Number
NCT02991768
Brief Title
Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients
Official Title
Budesonide for Mycophenolic Acid (MPA)-Induced Diarrhea in Renal Transplant Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Enrollment not continued
Study Start Date
January 27, 2017 (Actual)
Primary Completion Date
April 26, 2019 (Actual)
Study Completion Date
April 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pooja Budhiraja, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Entocort EC
Arm Type
Experimental
Arm Description
Subjects will take 6mg Entocort EC by mouth daily for 8 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will take 6mg matching placebo pill daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Entocort
Other Intervention Name(s)
budesonide
Intervention Description
A corticosteroid that decreases levels of inflammatory cytokines.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo is matched to the study drug.
Primary Outcome Measure Information:
Title
Complete remission of diarrhea
Description
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.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Change in Gastrointestinal Symptom Rating Scale (GSRS)
Description
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).
Time Frame
Change from Baseline to Week 8
Title
Change in Gastrointestinal Symptom Rating Scale (GSRS)
Description
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).
Time Frame
Change from Baseline to Week 16
Title
Change in Gastrointestinal Quality of Life Index (GIQLI)
Description
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.
Time Frame
Change from Baseline to Week 8
Title
Change in Gastrointestinal Quality of Life Index (GIQLI)
Description
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.
Time Frame
Change from Baseline to Week 16
Title
MPA Dose
Time Frame
Change from Baseline to Week 8
Title
MPA Dose
Time Frame
Change from Baseline to Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pooja Budhiraja, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients

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