Nafamostat Mesylate Versus Regional Citrate Anticoagulation for Continuous Renal Replacement Ther… (NCT07518303) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Nafamostat Mesylate Versus Regional Citrate Anticoagulation for Continuous Renal Replacement Therapy in Sepsis-Associated Acute Kidney Injury
1,162 participantsStarted 2026-06-10
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cau…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing nafamostat mesylate to regional citrate anticoagulation during CRRT — can you explain how these two approaches differ, and which one you would normally use for my care right now?
2Since this trial is Phase 4, does that mean both nafamostat and citrate anticoagulation already have an established safety record, and what specific risks should I be aware of with each option?
3The trial isn't recruiting yet — given that timing, would waiting to potentially join this study put me at any disadvantage compared to starting standard CRRT treatment right away?
4The main outcome this trial is measuring is something called MAKE30, which tracks major adverse kidney events at 30 days — can you help me understand what that means for my specific situation and how likely those events are with or without being in a trial?
5Are there factors in my current health — like the severity of my sepsis or how my kidneys are functioning — that would make me a good or poor candidate for this kind of study when it does open, and is there anything we should be doing now to keep my options open?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.