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NCT Number: NCT06147648

Early Conversion of Prolonged-release Tacrolimus in Liver Transplantation.

Tacrolimus is a commonly used immunosuppressant after liver transplantation. A once-daily administration of prolonged-release tacrolimus has been found to improve patient compliance and offer good efficacy and safety. Moreover, there is evidence that this prolonged-release formulation mitigates renal impairment and metabolic syndrome in transplant recipients. Foreign studies have confirmed that it is safe and feasible for liver transplant recipients to switch from immediate-release tacrolimus to prolonged-release tacrolimus during the stable period. At the same time, patients with early conversion are more likely to benefit in terms of graft survival and renal function recovery, and the proportion of drug conversion needs to be further explored.

This study aims to assess the efficacy and safety of switching from immediate-release tacrolimus to prolonged-release tacrolimus three months after liver transplantation. Furthermore, it seeks to investigate the impact of this conversion on indicators such as liver function, kidney function, metabolic disease incidence, and infection incidence in patients.

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Key information

Conditions

Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years old and above
  • 3 months after liver transplantation;
  • Stable use of immediate-release tacrolimus for at least one month before enrollment in the study;
  • The serum levels of aspartate aminotransferase [AST] and alanine aminotransferase [ALT] were within the normal range; ….

Exclusion criteria

  • Multi-organ combined transplantation or multiple liver transplantation;
  • Multiple organ recipients or those who have previously transplanted any organs；
  • Adjuvant liver transplantation or use of bioartificial liver therapy;
  • Prior to joining the group, they had received treatment with immune checkpoint (ICIs);
  • Participation in any other clinical study within 3 months prior to enrollment;
  • Use of tacrolimus sustained release capsules before enrollment;
  • Tacrolimus trough concentration lower than 5 ng/ml at the time of screening;
  • Acute rejection occurred within one month prior to enrollment; ….

Treatment and study plan

Tacrolimus Sustained-release Capsules

Drug

Transition from Immediate-release tacrolimus to prolonged-release tacrolimus at 3 months after liver transplantation

Primary outcomes

  1. Incidence of biopsy-confirmed acute rejection (BPAR) within 3, 6, and 12 months after conversion

    Time frame: within 3, 6, and 12 months after conversion

Secondary outcomes

  1. Graft survival rate and patient survival rate at 12 months after conversion

    Time frame: 12 months after conversion

  2. The conversion dose ratio from ordinary tacrolimus to tacrolimus sustained-release capsules;

    Time frame: 3 months after liver transplantation

  3. Incidence of infection (viral, bacterial and fungal) at 12 months after conversion;

    Time frame: 12 months after conversion;

  4. Observe the serum aspartate aminotransferase (AST) levels of subjects at 3, 6, and 12 months after switching to the prolonged-release tacrolimus.

    Time frame: within 3,6,12 months after conversion

  5. Observe the serum alanine aminotransferase (ALT) levels of subjects at 3, 6, and 12 months after switching to the prolonged-release tacrolimus.

    Time frame: within 3,6,12 months after conversion

  6. Observe the creatinine clearance rate of subjects at 3, 6, and 12 months after switching to the prolonged-release tacrolimus.

    Time frame: within 3,6,12 months after conversion

Study contacts

Contact information is provided by the study sponsor or research team.

XUAN TONG, Doctor

CONTACT

[email protected]

15901019879

Sponsors and collaborators

Lead sponsor

Beijing Tsinghua Chang Gung Hospital

Other

Registry information

Official study title

Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Liver Transplant Recipients

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 27, 2023
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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