Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients

NCT02991768 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: STUDY00140436
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 8

Secondary Outcomes (6)

• Change in Gastrointestinal Symptom Rating Scale (GSRS)

  Change from Baseline to Week 8

• Change in Gastrointestinal Symptom Rating Scale (GSRS)

  Change from Baseline to Week 16

• Change in Gastrointestinal Quality of Life Index (GIQLI)

  Change from Baseline to Week 8

• Change in Gastrointestinal Quality of Life Index (GIQLI)

  Change from Baseline to Week 16

• MPA Dose

  Change from Baseline to Week 8

Study Arms (2)

Entocort EC

EXPERIMENTAL

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

Drug: Entocort

Placebo

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

Entocort DRUG

A corticosteroid that decreases levels of inflammatory cytokines.

Also known as: budesonide

Entocort EC

Placebos DRUG

Placebo is matched to the study drug.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Diarrhea

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Clinical Research Coordinator
• Organization: University of Kansas Medical Center

edelaney2@kumc.edu

913-588-3520

Study Officials

• Pooja Budhiraja, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: December 13, 2016
• Study Start: January 27, 2017
• Primary Completion: April 26, 2019
• Study Completion: April 26, 2019
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-03

Locations

US (1)