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Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02991768
Recruitment Status : Terminated (Enrollment not continued)
First Posted : December 13, 2016
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Pooja Budhiraja, MD, University of Kansas Medical Center

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

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Study Type : Interventional  (Clinical Trial)
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 : January 27, 2017
Actual Primary Completion Date : April 26, 2019
Actual Study Completion Date : April 26, 2019

Resource links provided by the National Library of Medicine


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 Name: budesonide

Placebo Comparator: Placebo
Subjects will take 6mg matching placebo pill daily for 8 weeks.
Drug: Placebos
Placebo is matched to the study drug.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. MPA Dose [ Time Frame: Change from Baseline to Week 8 ]
  6. MPA Dose [ Time Frame: Change from Baseline to Week 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991768


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Pooja Budhiraja, MD
Investigators
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Principal Investigator: Pooja Budhiraja, MD University of Kansas Medical Center

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Responsible Party: Pooja Budhiraja, MD, Assistant Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02991768    
Other Study ID Numbers: STUDY00140436
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019

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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
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Mycophenolic Acid
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action