Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-27

Study Completion Date

2019-04-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Entocort EC

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

Group Type EXPERIMENTAL

Entocort

Intervention Type DRUG

A corticosteroid that decreases levels of inflammatory cytokines.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Placebo is matched to the study drug.

Interventions

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Entocort

A corticosteroid that decreases levels of inflammatory cytokines.

Intervention Type DRUG

Placebos

Placebo is matched to the study drug.

Intervention Type DRUG

Other Intervention Names

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budesonide

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No