Budesonide for Liver Transplant Immune Suppression

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03304626
Recruitment Status : Recruiting
First Posted : October 9, 2017
Last Update Posted : October 11, 2018
American College of Gastroenterology
Information provided by (Responsible Party):
Khurram Bari, University of Cincinnati

Brief Summary:

This is a pilot study that investigates the efficacy and safety of budesonide as an immune suppressing agent for liver transplant recipients in the early post-transplant period.

The primary end-point is rates of acute cellular rejection within first 24 weeks post-liver transplant. Secondary end points include rates of new onset diabetes after transplant and safety of budesonide.

The study is structured as a prospective clinical trial. After receiving 4 days of intravenous corticosteroids on liver transplant post-operative days 0 through 3, subjects will be started on standard immunosuppression plus enteric coated budesonide (study drug) in place of standard immune suppression plus prednisone (standard of care). Study drug will be tapered over 12 weeks in accordance with the existing standard of care immune suppression protocol. Subjects will be followed in outpatient transplant clinic for 24 weeks. The purpose of the study is to conduct a pilot study to generate rates and effect size that can be used in a subsequent equivalent trial. A total of 20 subjects will be enrolled to receive the standard immunosuppression plus budesonide and their outcomes will be compared to 20 controls receiving standard immunosuppression plus prednisone (standard of care). The use of controls is to generate rate and variability that can be compared with the rate obtained from patients that receive study drug by examining the 95% confidence band.

Condition or disease Intervention/treatment Phase
Acute Cellular Graft Rejection New Onset Diabetes After Transplant Drug: Budesonide 3Mg Capsule Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 20 subjects will receive open label Budesonide along with standard immune suppression and their outcomes will be compared to 20 matched controls receiving standard of care treatment including prednisone plus standard immune suppression
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Efficacy and Safety of Budesonide as an Alternative to Prednisone for Liver Transplant Immune Suppression
Actual Study Start Date : June 27, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

Arm Intervention/treatment
Experimental: Study Group

Budesonide EC 3 mg capsule. The dose will be as follows

Time post Liver Transplantation Immunosuppressive therapy Days 0-3 Standard immune suppression (SIS) + Intravenous corticosteroids Days 4-30 SIS + Budesonide 9 mg Days 31-45 SIS + Budesonide 6 mg Days 46-90 SIS + Budesonide 3 mg Days 90 onwards SIS1

Drug: Budesonide 3Mg Capsule
Budesonide capsule in place of prednisone (standard of care)

Primary Outcome Measures :
  1. Rates of Acute Cellular Rejection [ Time Frame: Post-Transplant day 4 to week 24 ]
    Acute Cellular Rejection of liver graft as determined by liver biopsy using Banff criteria

Secondary Outcome Measures :
  1. Rate of New Onset Diabetes After Transplant [ Time Frame: Post-Transplant day 4 to week 24 ]
    Rates of new onset diabetes in patients who did not have diabetes prior to liver transplant

  2. Effect of Budesonide on hypothalamic-pituitary-adrenal axis [ Time Frame: Post-Transplant week 12 ]
    This will be measured by measuring early morning serum cortisol levels during the first 8 weeks and a one-time ACTH stimulation test at week 12

  3. Safety of Budesonide [ Time Frame: Post-Transplant day 4 to week 24 ]
    Rates of adverse events and severe adverse events including viral, fungal and bacterial infection

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female or male subjects aged 21-75 years old
  • Received a primary liver transplant within 4 days of enrollment

Exclusion Criteria:

  • Received previous organ transplants
  • Undergoing multiple organ transplants
  • Recipients with advanced fibrosis in graft
  • Treatment plan for subject includes receiving immunosuppressant therapy other than standard immune suppression (SIS) as per University of Cincinnati LT immune suppression protocol (UC-ISP).
  • Inability to take enteral (orally or by tube feed) medications by day 4 post-transplant
  • Subjects with diabetes mellitus prior to transplant (diabetes mellitus defined as use of hypoglycemic agents or HbA1c > 6.4 prior to transplant)
  • Subjects who have any severe medical condition requiring acute or chronic treatment that in the investigator's opinion would interfere with study participation.
  • Subjects who have been exposed to an investigational therapy within 30 days prior to enrollment or 5 half-lives on the investigational product, whichever is greater.
  • Subjects in which concomitant use of medications which are inhibitors of CYP3A4 (such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin) cannot be avoided during the study period.
  • Pregnant females
  • Diminished mental capacity to consent for the study as determined by attending on the record.

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 identifier (NCT number): NCT03304626

Contact: Khurram Bari, MD 513-558-2898

United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Khurram Bari, MD    513-558-2898   
Sponsors and Collaborators
University of Cincinnati
American College of Gastroenterology
  Study Documents (Full-Text)

Documents provided by Khurram Bari, University of Cincinnati:

Responsible Party: Khurram Bari, Assistant Professor, University of Cincinnati Identifier: NCT03304626     History of Changes
Other Study ID Numbers: 2016-1488
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents