Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07518303

PHASE4

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

Sponsor: Jianfeng Xie

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

1162

Start Date

2026-06-10

Completion Date

2028-12-10

Last Updated

2026-06-03

Healthy Volunteers

Conditions

Sepsis Acute Kidney Injury Continuous Renal Replacement Therapy (CRRT)

Interventions

DRUG

Citrate anticoagulation

Citrate (3% or 4% trisodium citrate solution) is a regional anticoagulant that chelates ionized calcium in the extracorporeal circuit, thereby inhibiting the coagulation cascade. The control product is supplied as an injection solution. It should be stored in a tightly closed container. During CRRT, citrate is infused pre-filter (before the blood pump) and requires separate systemic calcium replacement to maintain normal ionized calcium levels.

DRUG

Nafamostat Mesylate

Nafamostat mesylate is a synthetic serine protease inhibitor with a very short half-life (approximately 8 minutes). It acts locally as an anticoagulant by inhibiting thrombin, factor Xa, and other coagulation proteases. The investigational product is supplied as a lyophilized powder for injection. It must be protected from light and stored below 25 °C. For use during continuous renal replacement therapy (CRRT), the powder is reconstituted and administered as a continuous pre-filter infusion.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria