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Anrikefon Injection in Postoperative Patients: PK/PD Integration Study Using Population Pharmacokinetic Modeling and PBPK-Driven Prediction of Nephrotoxicity in Special Populations

Anrikefon Injection in Postoperative Patients: PK/PD Integration Study Using Population Pharmacokinetic Modeling and PBPK-Driven Prediction of Nephrotoxicity in Special Populations

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113676
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Pain after abdominal surgery

Interventions

Anrelifin Analgesia Observation Group:None

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate in this study and sign a written, dated informed consent form. 2. Aged between 18 and 65 years, regardless of gender. 3. Undergoing elective or emergency abdominal surgery, requiring postoperative analgesia with Anrekfen injection. 4. Expected postoperative hospital stay of =72 hours, able to cooperate with the assessments and blood sample collection required for this study. 5. Conscious, with normal communication abilities, capable of accurately describing pain levels and completing the NRS scoring.

Exclusion criteria

Exclusion criteria: 1. Known allergy to Anrikefon or any of its excipients. 2. Patients with severe cardiac insufficiency (NYHA Class III-IV), severe hepatic insufficiency (Child-Pugh Class C), severe renal insufficiency (estimated glomerular filtration rate eGFR < 30 mL/min/1.73m²), or those requiring renal replacement therapy. 3. Pregnant or lactating women. 4. Concurrent use of other medications that may significantly affect the analgesic efficacy or pharmacokinetics of Anruikefen. 5. Patients with severe neurological or psychiatric disorders leading to impaired consciousness, cognitive dysfunction, or inability to reliably assess pain. 6. History of drug abuse (e.g., opioids, sedative-hypnotics) or alcohol dependence. 7. Concurrent participation in other drug clinical trials.

Design outcomes

Primary

MeasureTime frame
Correlation between plasma concentration and NRS score;Renal Function Parameters;

Secondary

MeasureTime frame
Incidence of Adverse Events;

Countries

China

Contacts

Public ContactZhai Xuejia

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

zhaixuejia@163.com+86 27 8572 6073

Outcome results

None listed

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