Investigation of Pain Incidence After FK506 Immunosuppressive Therapy in Liver Transplantation Patients
Unknown statusNCT04559048
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Investigation of Pain Incidence After FK506 Immunosuppressive Therapy in Liver Transplantation Patients
- Conditions
- Chronic Pain
- Liver Transplantation
- Interventions
- Drug: FK506
- Sponsor
- The Second Hospital of Tangshan
- Collaborators
- Chinese PLA General Hospital
- Start date
- 2019-09-15
- Primary completion
- 2024-03-15
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- China
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 -
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04559048