Nafamostat Mesylate Versus Regional Citrate Anticoagulation for Continuous Renal Replacement Therapy in Sepsis-Associated Acute Kidney Injury

Starting soon · Phase 4

Conditions studied: Sepsis, Acute Kidney Injury, Continuous Renal Replacement Therapy (CRRT)

In brief

This multicenter, randomized, open-label, active-controlled, parallel-group trial will evaluate the efficacy and safety of nafamostat mesylate anticoagulation compared with regional citrate anticoagulation in adult patients with sepsis-associated acute kidney injury requiring continuous renal replacement therapy. Eligible participants will be randomized in a 1:1 ratio to receive either nafamostat mesylate or regional citrate anticoagulation during CRRT. The primary outcome is MAKE30, a composite of all-cause mortality, new or ongoing renal replacement therapy, or persistent renal dysfunction within 30 days after randomization. Secondary outcomes include filter lifespan, CRRT-free days, 30-day all-cause mortality, renal replacement therapy status, persistent renal dysfunction, ICU and hospital mortality, length of stay, CRRT duration, major bleeding, new bloodstream infection during ICU stay, SOFA score, number of filters used, and protocol-defined safety outcomes.

Key facts

Study ID

NCT07518303

Run by

Jianfeng Xie

People needed

1162

Starts

2026-06-10

Expected to finish

2028-12-10

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 to 90 years, inclusive, regardless of sex.
• Meets Sepsis 3.0 diagnostic criteria and develops acute kidney injury within 7 days after the diagnosis of sepsis.
• After adequate resuscitation, meets KDIGO 2012 stage 2 or stage 3 acute kidney injury criteria, including any of the following:
• Serum creatinine increased to more than 3 times baseline; or Serum creatinine ≥4.0 mg/dL [353.6 μmol/L]; or Urine output <0.3 mL/kg/h for ≥24 hours; or Anuria, defined as extremely low or absent urine output, lasting ≥12 hours.
• Or has an indication for CRRT, including any of the following:
• Blood urea nitrogen >150 mg/dL; or Serum potassium >6 mmol/L; or pH <7.15; or Organ edema and/or fluid overload in the setting of AKI that is refractory to diuretic therapy.
• Expected duration of CRRT treatment >48 hours.
• Written informed consent obtained.

You may not qualify if…

• Requirement for therapeutic anticoagulation, such as pulmonary embolism or deep vein thrombosis.
• Contraindication to systemic anticoagulation.
• Hemolytic uremic syndrome or thrombotic thrombocytopenic purpura.
• Acute liver failure and/or shock with persistent severe lactic acidosis, defined as two consecutive measurements of pH <7.2 lasting for more than 2 hours, with lactate >72.1 mg/dL [8 mmol/L].
• Chronic kidney disease requiring long-term regular dialysis.
• Acute kidney injury caused by permanent bilateral renal artery occlusion or surgical injury.
• Acute kidney injury caused by glomerulonephritis, interstitial nephritis, or vasculitis.
• Known allergy to study drugs, including nafamostat mesylate, sodium citrate, or their excipients.
• Kidney transplantation within 1 year.
• Planning pregnancy in the near term, pregnancy, or lactation.
• HIV infection.
• Only adsorptive filters such as oXiris are available at study enrollment.
• Participation in another clinical trial within the previous 3 months.
• Judged by the investigator to be in a moribund state or unlikely to complete the study intervention and primary outcome assessment, including but not limited to expected death within 24 hours after enrollment, decision for do-not-resuscitate order or limitation/withdrawal of life-sustaining treatment, or planned abandonment of active treatment and self-discharge within 24 hours due to terminal disease or patient/family preference.
• Any other condition that, in the investigator's judgment, makes the patient unsuitable for enrollment.

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.