Investigation of Pain Incidence After FK506 Immunosuppressive Therapy in Liver Transplantation Patients

January 19, 2024 updated by: The Second Hospital of Tangshan
FK506 (tacrolimus), a calcineurin inhibitor, is widely used as an immunosuppressant to lower the risk of organ rejection after organ transplantation, and to treat T cell-mediated diseases such as eczema and atopic dermatitis. FK506 treatment often accompanies pain sensation in patients with atopic dermatitis or after organ transplantation. In previous studies, the investigators confirmed that FK506 treatment increased neuronal activity of primary afferent neurons and causes pain behavior in naïve mice. In order to further search for objective clinical evidence, the investigators proposed to investigate pain incidence after FK506 immunosuppressive therapy in liver transplantation patients. The investigators will investigate pain incidence and pain intensity in patients who underwent liver transplant from September of 2011 to May of 2018 in the Liver Health Rehabilitation Association. The patients who were divided into two groups based on whether or not FK506 was used in the immunosuppressive therapy. The patients in control group (without FK506 treatment) and FK506-treated group report pain sensation 3 months and 12 months after liver transplant. The investigators will compare the pain incidence between the two groups at both time points. On the other hand, the investigators will further investigate changes in pain sensation after 1st and 2nd reductions of FK506 dose. Pain is reported subjectively by the patient using the visual analogue scale (VAS) 1 month after dose reduction. In our study, 1st and 2nd reductions of FK506 dose refers to the first two dose-adjustments (approximately 6 months apart) that occurred 3-6 months after the liver transplantation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Gang Zhao, M.D.
  • Phone Number: +8603152058037
  • Email: tseyyjk@163.com

Study Locations

  • China
    • Hebei
      • Tangshan, Hebei, China, 063000
        • Recruiting
        • The Second Hospital of Tangshan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

A retrospective study was conducted in patients who underwent liver transplant from September of 2011 to May of 2018 in the Liver Health Rehabilitation Association(China)

Description

Inclusion Criteria:

  1. had liver transplantation for end-stage liver disease
  2. was ≥18 years of age at the time of liver transplantation -

Exclusion Criteria:

  1. liver cancer
  2. acute (fulminant) liver failure
  3. multiorgan transplant
  4. chronic postsurgical pain
  5. fibromyalgia, osteoarthritis, low back pain and inflammatory pain of any origin
  6. peripheral and central neuropathic pain of any origin
  7. chronic secondary visceral pain
  8. chronic cancer-related pain that is due to cancer or its treatment -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
FK506-treated group
In FK506-treated group, the patients who underwent liver transplant are treated with FK506 immunosuppressive therapy.
Drug: FK506
FK506 (tacrolimus), a calcineurin inhibitor, is widely used as an immunosuppressant to lower the risk of organ rejection after organ transplantation
control group without FK506 treatment
In control group, the patients who underwent liver transplant are treated without FK506.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain incidence
Time Frame: within 2 years after liver transplantation
Pain is defined as painful sensation that lasts or recurs for 1-3 months within 3 months after liver transplantation, or for longer than 3 months within 12 months after liver transplantation.
within 2 years after liver transplantation
pain intensity
Time Frame: within 2 years after liver transplantation
Pain is reported subjectively by the patient using the visual analogue scale (VAS)
within 2 years after liver transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Tangshan

Collaborators

Chinese PLA General Hospital

Investigators

  • Study Chair: Dequn Liu, M.D., The Second Hospital of Tangshan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2019

Primary Completion (Estimated)

March 15, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

September 16, 2020

First Submitted That Met QC Criteria

September 16, 2020

First Posted (Actual)

September 22, 2020

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBTS1411206

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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