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

NCT04559048 | Unknown DMC

• 1 other identifier: HBTS1411206
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain; Liver Transplantation

Keywords

Chronic Pain; Liver Transplantation; FK506

Outcome Measures

Primary Outcomes (2)

• pain incidence

  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

  Pain is reported subjectively by the patient using the visual analogue scale (VAS)

  within 2 years after liver transplantation

Study Arms (2)

FK506-treated group

In FK506-treated group, the patients who underwent liver transplant are treated with FK506 immunosuppressive therapy.

Drug: FK506

control group without FK506 treatment

In control group, the patients who underwent liver transplant are treated without FK506.

Interventions

FK506 DRUG

FK506 (tacrolimus), a calcineurin inhibitor, is widely used as an immunosuppressant to lower the risk of organ rejection after organ transplantation

FK506-treated group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

• liver cancer
• acute (fulminant) liver failure
• multiorgan transplant
• chronic postsurgical pain
• fibromyalgia, osteoarthritis, low back pain and inflammatory pain of any origin
• peripheral and central neuropathic pain of any origin
• chronic secondary visceral pain
• chronic cancer-related pain that is due to cancer or its treatment -

Sponsors & Collaborators

• The Second Hospital of Tangshan: lead
• Chinese PLA General Hospital: collaborator

Study Sites (1)

The Second Hospital of Tangshan

Tangshan, Hebei, 063000, China

RECRUITING

Related Publications (2)

• Reitamo S, Rustin M, Ruzicka T, Cambazard F, Kalimo K, Friedmann PS, Schoepf E, Lahfa M, Diepgen TL, Judodihardjo H, Wollenberg A, Berth-Jones J, Bieber T; European Tacrolimus Ointment Study Group. Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone butyrate ointment in adult patients with atopic dermatitis. J Allergy Clin Immunol. 2002 Mar;109(3):547-55. doi: 10.1067/mai.2002.121832.

  PMID: 11898005 BACKGROUND

• Malat GE, Dupuis RE, Kassman B, Rhoads JM, Freeman K, Lichtman S, Johnson MW, Gerber D, Andreoni K, Fair J. Tacrolimus-induced pain syndrome in a pediatric orthotopic liver transplant patient. Pediatr Transplant. 2002 Oct;6(5):435-8. doi: 10.1034/j.1399-3046.2002.02030.x.

  PMID: 12390434 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Dequn Liu, M.D.

  The Second Hospital of Tangshan

  STUDY CHAIR

Central Study Contacts

Gang Zhao, M.D.

CONTACT

+8603152058037; tseyyjk@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 22, 2020
• Study Start: September 15, 2019
• Primary Completion: March 15, 2024
• Study Completion: June 30, 2024
• Last Updated: January 22, 2024

Record last verified: 2024-01

Locations

CN (1)