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To evaluate the efficacy and safety of tacrolimus extended-release capsules and tacrolimus capsules in early postoperative immunosuppression in adult DCD liver transplantation recipients: a single-center, open-label, randomized controlled trial

To evaluate the efficacy and safety of tacrolimus extended-release capsules and tacrolimus capsules in early postoperative immunosuppression in adult DCD liver transplantation recipients: a single-center, open-label, randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020719
Enrollment
Unknown
Registered
2019-01-15
Start date
2018-01-12
Completion date
Unknown
Last updated
2019-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver transplantation

Interventions

ADV:extended-release tacrolimus
PRG:tacrolimus

Sponsors

Shulan (Hangzhou) Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years old at enrollment; 2. Liver transplant recipients whose graft fitting criteria of donation after circulatory death; 3. Women of childbearing age promise to contraception during the trial; 4. Signing informed consent.

Exclusion criteria

Exclusion criteria: 1. Receiving other organ transplant patients other than liver transplantation; 2. Allergic to tacrolimus and other basic medications; 3. Suffering from uncontrollable local or systemic infections; 4. HIV positive recipient or donor; 5. Have severe diarrhea or vomiting, active upper gastrointestinal ulcer or malabsorption; 6. Have serious heart and lung disease; 7. Pregnant or lactating women; 8. Failure to comply with the protocol due to psychological, family, social, geographic or other reasons; 9. Participate in other clinical trials within 1 month prior to enrollment; 10. Patient refused to sign informed consent.

Design outcomes

Primary

MeasureTime frame
The incidence of biopsy-proven acute rejection (BPAR) within 30 days after liver transplantation;

Secondary

MeasureTime frame
Dose of tacrolimus;Trough concentration of tacrolimus;The incidence of biopsy-proven acute rejection (BPAR) within 24 weeks after liver transplantation;Rate of graft loss;Patient survival rate;

Countries

China

Contacts

Public ContactZheng Shusen

Shulan (Hangzhou) Hospital

shusenzheng@zju.edu.cn+86 13805749805

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026