Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients

Sponsor

Pooja Budhiraja, MD (Other)

Overall Status

Terminated

CT.gov ID

NCT02991768

Collaborator

(none)

Enrollment

Location

Arms

26.9

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diarrhea	Drug: Entocort Drug: Placebos	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 27, 2017

Actual Primary Completion Date :

Apr 26, 2019

Actual Study Completion Date :

Apr 26, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Entocort EC Subjects will take 6mg Entocort EC by mouth daily for 8 weeks.	Drug: Entocort A corticosteroid that decreases levels of inflammatory cytokines. Other Names: budesonide
Placebo Comparator: Placebo Subjects will take 6mg matching placebo pill daily for 8 weeks.	Drug: Placebos Placebo is matched to the study drug.

Arm

Intervention/Treatment

Experimental: Entocort EC

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

Drug: Entocort

A corticosteroid that decreases levels of inflammatory cytokines.

Other Names:

budesonide

Placebo Comparator: Placebo

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

Drug: Placebos

Placebo is matched to the study drug.

Outcome Measures

Primary Outcome Measures

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

Change in Gastrointestinal Symptom Rating Scale (GSRS) [Change from Baseline to Week 8]
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) [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 8]
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) [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 8]
MPA Dose [Change from Baseline to Week 16]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

Pooja Budhiraja, MD

Investigators

Principal Investigator: Pooja Budhiraja, MD, University of Kansas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pooja Budhiraja, MD, Assistant Professor, University of Kansas Medical Center

ClinicalTrials.gov Identifier:

NCT02991768

Other Study ID Numbers:

STUDY00140436

First Posted:

Dec 13, 2016

Last Update Posted:

May 20, 2019

Last Verified:

May 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Diarrhea

Budesonide

Study Results

No Results Posted as of May 20, 2019