Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients

Overview

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.

Full Title of Study: “Budesonide for Mycophenolic Acid (MPA)-Induced Diarrhea in Renal Transplant Recipients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 26, 2019

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Entocort EC
    • Subjects will take 6mg Entocort EC by mouth daily for 8 weeks.
  • Placebo Comparator: Placebo
    • Subjects will take 6mg matching placebo pill daily for 8 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Complete remission of diarrhea
    • Time Frame: 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 Measures

  • Change in Gastrointestinal Symptom Rating Scale (GSRS)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: Change from Baseline to Week 8
  • MPA Dose
    • Time Frame: Change from Baseline to Week 16

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pooja Budhiraja, MD
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Pooja Budhiraja, MD, Assistant Professor – University of Kansas Medical Center
  • Overall Official(s)
    • Pooja Budhiraja, MD, Principal Investigator, University of Kansas Medical Center

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