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A Randomized, Active-Controlled, Open-Label Clinical Study of Nafamostat Mesylate for Reducing Bleeding Risk in Maintenance Hemodialysis Patients at High Risk of Bleeding

A Randomized, Active-Controlled, Open-Label Clinical Study of Nafamostat Mesylate for Reducing Bleeding Risk in Maintenance Hemodialysis Patients at High Risk of Bleeding

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116304
Enrollment
Unknown
Registered
2026-01-08
Start date
2026-03-31
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Maintenance hemodialysis

Interventions

Enoxaparin Anticoagulation Control Group:Anticoagulation therapy with sodium enoxaparin (0.6 mL: 6000 AXa IU/vial, Tianjin Hongri Pharmaceutical Co., Ltd.) was administered at a dose of 2000–5000 IU.
Nafamostat Mesylate Anticoagulation Group:Anticoagulation therapy with nafamostat mesylate was administered, with an initial dose of 30 mg/h (adjusted based on ACT results), provided by Jiangsu Duer P

Sponsors

The Seventh Affiliated Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age 18–75 years, sex and ethnicity unrestricted. 2.Confirmed chronic kidney disease stage 5 on maintenance hemodialysis (2–3 sessions/week for > 3 months). 3.Concomitant use of anticoagulants (warfarin, NOACs) and/or antiplatelet agents (aspirin, glycoprotein IIb/IIIa inhibitors, etc.); 4.Signed written informed consent.

Exclusion criteria

Exclusion criteria: 1.Known hypersensitivity to anticoagulants such as nafamostat mesylate, heparin, or heparin analogues. 2.Any contraindication to anticoagulation, including coagulation disorders, active bleeding, heparin-induced thrombocytopenia, or documented allergy to anticoagulant agents. 3.Life expectancy < 3 months. 4.Severe cardiac, hepatic, or respiratory failure; active malignancy. 5.Unable or unwilling to provide written informed consent. 6.Enrollment in any other clinical study within the past 3 months.

Design outcomes

Primary

MeasureTime frame
The incidence of major bleeding events;;

Secondary

MeasureTime frame
Adverse events;Anticoagulant efficacy;Dialysis adequacy;The incidence of non-major bleeding events;

Countries

China

Contacts

Public ContactLei Yan

The Seventh Affiliated Hospital Sun Yat-sen University

hsxr8308@126.com+86 755 81206801

Outcome results

None listed

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