SepsisPhase 4NICE-AKINCT07518303
Nafamostat Mesylate Versus Regional Citrate Anticoagulation for Continuous Renal Replacement Therapy in Sepsis-Associated Acute Kidney Injury
A Phase 4 study testing Citrate anticoagulation and Nafamostat Mesylate in people with Sepsis and Acute Kidney Injury, run by Jianfeng Xie.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sepsis, Acute Kidney Injury, Continuous Renal Replacement Therapy (CRRT)
- What is being tested?
- Citrate anticoagulation and Nafamostat Mesylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,162 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2026to 10 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
Sepsis-associated acute kidney injury is common among critically ill patients and is associated with increased mortality, delayed renal recovery, and adverse long-term kidney outcomes. Continuous renal replacement therapy is frequently used in hemodynamically unstable patients with severe AKI, and its effective delivery depends on extracorporeal circuit patency and appropriate anticoagulation. Regional citrate anticoagulation is recommended as a first-line CRRT anticoagulation strategy in patients without contraindications, but citrate accumulation, electrolyte disturbances, and acid-base disorders may occur in patients with severe shock, liver dysfunction, or complex metabolic derangements. Nafamostat mesylate is a short-acting serine protease inhibitor with anticoagulant effects that are relatively confined to the extracorporeal circuit and may be associated with a lower systemic bleeding risk.
This study will compare nafamostat mesylate with regional citrate anticoagulation in patients with sepsis-associated acute kidney injury undergoing CRRT. The trial is designed as a multicenter, randomized, open-label, active-controlled, parallel-group non-inferiority study. Participants will be randomized centrally using the IWRS, stratified by study center and SOFA cardiovascular subscore. The primary objective is to determine whether nafamostat mesylate is non-inferior to regional citrate anticoagulation with respect to MAKE30, defined as death, new or ongoing renal replacement therapy, or persistent renal dysfunction within 30 days after randomization.
- Being tested
- Citrate anticoagulation, Nafamostat Mesylate
- Keywords
- Nafamostat Mesylate, Continuous Renal Replacement Therapy (CRRT), Sepsis, Acute Kidney Injury (AKI), Randomized Clinical Trial (RCT)
- Medical subject headings
- Sepsis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citrate anticoagulationDrug
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.
Nafamostat MesylateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Citrate group | Active comparator | Participants in this arm receive regional citrate anticoagulation during continuous renal replacement therapy (CRRT) according to standard institutional protocols. Citrate is infused pre-filter to maintain post-filter ionized calcium concentration between 0.2-0.4 mmol/L, with a maximum not exceeding 0.6 mmol/L. Calcium is replaced post-filter or systemically to maintain normal systemic ionized calcium (1.0-1.2 mmol/L). Anticoagulation targets and dose adjustments follow predefined operational guidelines. Citrate accumulation is monitored by total-to-ionized calcium ratio, and protocol modifications are applied for patients with liver dysfunction or metabolic complications. Receives: Drug: Citrate anticoagulation |
| NM group | Experimental | Nafamostat mesylate is administered as a continuous pre-filter infusion at an initial dose of 50 mg/h, adjusted to maintain activated partial thromboplastin time (aPTT) or other regional anticoagulation parameters as specified in the protocol. Dose modifications are made based on filter lifespan and bleeding risk. Receives: Drug: Nafamostat Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Kidney Events at Day 30 (MAKE30)
MAKE30 is a composite endpoint defined as the occurrence of any of the following within 30 days after randomization:
- All-cause death: the participant dies within 30 days after enrollment. If death has not occurred, proceed to the next criterion.
- New initiation of or persistent need for renal replacement therapy: on Day 30 after enrollment, the participant still requires any form of renal replacement therapy, including CRRT, intermittent hemodialysis, sustained low-efficiency daily dialysis/continuous intermittent renal replacement therapy, peritoneal dialysis, and related modalities. Even if the participant had been temporarily weaned from therapy during the interval, the event is considered to have occurred if renal replacement therapy is still required on Day 30. If this criterion is not met, proceed to the next criterion.
- Persistent renal dysfunction: on Day 30, the participant's serum creatinine level reaches or exceeds twice the baseline value.
Measured: From randomization to day 30
Secondary outcomes (14)
Mean filter lifespan
Defined as the time from CRRT initiation to technical filter failure or nontechnical termination. Nontechnical termination events will be censored in the primary analysis.
- Technical filter failure (meeting any of the following):
- transmembrane pressure (TMP) persistently > 250 mmHg and not reversible after flushing or adjusting blood flow rate; b. visible circuit clotting at grade 2-3 (grade 0: no visible clotting; grade 1: mild fibrin deposition; grade 2: obvious clotting but the circuit remains functional; grade 3: severe clotting requiring immediate filter replacement); c. complete occlusion of the filter or circuit such that blood flow > 100 mL/min cannot be maintained; or d. unplanned treatment interruption caused by circuit clotting.
- Nontechnical termination (not counted as filter failure)
Measured: From first CRRT initiation to last CRRT discontinuation within 30 days after randomization
CRRT-free days through Day 30
Measured: From randomization to day 30
All-cause mortality by Day 30
Measured: From randomization to day 30
New or Ongoing Renal Replacement Therapy
Requirement for any form of renal replacement therapy at days 27-33 after enrollment, including CRRT, intermittent hemodialysis, slow low-efficiency daily dialysis, sustained low-efficiency dialysis, peritoneal dialysis, or any other form of renal replacement therapy.
Measured: Days 27-33 after randomization
Persistent Renal Dysfunction at Day 30
Serum creatinine at day 30 reaching or exceeding 2 times baseline. If the day 30 value is unavailable, the last available pre-discharge serum creatinine value will be used. Baseline serum creatinine will be defined or estimated according to the protocol-specified hierarchy.
Measured: Day 30 after randomization
ICU mortality
Measured: To be evaluated up to 30 days post randomization
In-hospital mortality
Measured: To be evaluated up to 30 days post randomization
ICU length of stay
Measured: To be evaluated up to 30 days post randomization
Hospital length of stay
Measured: To be evaluated up to 30 days post randomization
Duration of CRRT
Measured: From first CRRT initiation to last CRRT discontinuation within 30 days after randomization
Major Bleeding Events
Major bleeding is defined as any of the following: life-threatening bleeding associated with hypovolemic shock, such as bleeding caused by ruptured abdominal aortic aneurysm or upper or lower gastrointestinal bleeding; life-threatening bleeding at a critical site, such as intracranial, retroperitoneal, or pericardial bleeding; overt clinically important bleeding associated within 24 hours with hemoglobin decrease >20 g/L or transfusion of ≥2 units of packed red blood cells; or bleeding requiring invasive intervention, such as re-operation.
Measured: From randomization to day 30
New Bloodstream Infection During ICU Stay
New bloodstream infection is defined as a bloodstream infection event that occurs during the study observation period and is not present at baseline. The event must meet the following criteria: during the same suspected infection assessment, blood culture specimens are independently collected and submitted from at least two different peripheral venipuncture sites on the same day or consecutive days, and the same pathogenic microorganism is detected in the separately reported cultures. For participants with baseline bloodstream infection, a new bloodstream infection will be identified only when the newly detected pathogen differs from the baseline pathogen or when the clinical endpoint adjudication committee determines that the event represents a new bloodstream infection.
Measured: During ICU stay within 30 days after randomization
SOFA scores on Days 1, 3, 7, 14, and 30
Measured: From randomization to day 30
Total number of filters used during CRRT
Measured: From randomization to day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start10 Jun 2026 (estimated)
- Primary completion10 Jun 2028 (estimated)
- Study completion10 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianfeng Xie
- Sponsor type
- University, hospital or other
- Collaborators
- Southeast University, China
- Responsible party
- Sponsor-investigator, Jianfeng Xie, Southeast University, China
- Investigators
- Yingzi Huang, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518303
- Sponsor's protocol ID
- 2026ZDSYLL076-P01
- Acronym
- NICE-AKI
- Status last verified
- Jun 2026
- First submitted
- 29 Mar 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nafamostat Mesylate Versus Regional Citrate Anticoagulation for Continuous Renal Replacement Therapy in Sepsis-Associated Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT07518303
- Acronym / sponsor ID
- NICE-AKI / 2026ZDSYLL076-P01
- Keywords
- Nafamostat Mesylate, Continuous Renal Replacement Therapy (CRRT), Sepsis, Acute Kidney Injury (AKI), Randomized Clinical Trial (RCT)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,162 participants (estimated)
- Lead sponsor
- Jianfeng XieUniversity, hospital or other
- Collaborators
- Southeast University, China
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 10 Jun 2028 (estimated)
- Study completion
- 10 Dec 2028 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sepsis-associated acute kidney injury is common among critically ill patients and is associated with increased mortality, delayed renal recovery, and adverse long-term kidney outcomes. Continuous renal replacement therapy is frequently used in hemodynamically unstable patients with severe AKI, and its effective delivery depends on extracorporeal circuit patency and appropriate anticoagulation. Regional citrate anticoagulation is recommended as a first-line CRRT anticoagulation strategy in patients without contraindications, but citrate accumulation, electrolyte disturbances, and acid-base disorders may occur in patients with severe shock, liver dysfunction, or complex metabolic derangements. Nafamostat mesylate is a short-acting serine protease inhibitor with anticoagulant effects that are relatively confined to the extracorporeal circuit and may be associated with a lower systemic bleeding risk.
This study will compare nafamostat mesylate with regional citrate anticoagulation in patients with sepsis-associated acute kidney injury undergoing CRRT. The trial is designed as a multicenter, randomized, open-label, active-controlled, parallel-group non-inferiority study. Participants will be randomized centrally using the IWRS, stratified by study center and SOFA cardiovascular subscore. The primary objective is to determine whether nafamostat mesylate is non-inferior to regional citrate anticoagulation with respect to MAKE30, defined as death, new or ongoing renal replacement therapy, or persistent renal dysfunction within 30 days after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citrate group | Active comparator | Drug: Citrate anticoagulationParticipants in this arm receive regional citrate anticoagulation during continuous renal replacement therapy (CRRT) according to standard institutional protocols. Citrate is infused pre-filter to maintain post-filter ionized calcium concentration between 0.2-0.4 mmol/L, with a maximum not exceeding 0.6 mmol/L. Calcium is replaced post-filter or systemically to maintain normal systemic ionized calcium (1.0-1.2 mmol/L). Anticoagulation targets and dose adjustments follow predefined operational guidelines. Citrate accumulation is monitored by total-to-ionized calcium ratio, and protocol modifications are applied for patients with liver dysfunction or metabolic complications. |
| NM group | Experimental | Drug: Nafamostat MesylateNafamostat mesylate is administered as a continuous pre-filter infusion at an initial dose of 50 mg/h, adjusted to maintain activated partial thromboplastin time (aPTT) or other regional anticoagulation parameters as specified in the protocol. Dose modifications are made based on filter lifespan and bleeding risk. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Citrate anticoagulationCitrate (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 | Citrate group |
| Nafamostat MesylateNafamostat 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. | Drug | NM group |
Primary outcome
Major Adverse Kidney Events at Day 30 (MAKE30)
Time frame: From randomization to day 30
MAKE30 is a composite endpoint defined as the occurrence of any of the following within 30 days after randomization: 1. All-cause death: the participant dies within 30 days after enrollment. If death has not occurred, proceed to the next criterion. 2. New initiation of or persistent need for renal replacement therapy: on Day 30 after enrollment, the participant still requires any form of renal replacement therapy, including CRRT, intermittent hemodialysis, sustained low-efficiency daily dialysis/continuous intermittent renal replacement therapy, peritoneal dialysis, and related modalities. Even if the participant had been temporarily weaned from therapy during the interval, the event is considered to have occurred if renal replacement therapy is still required on Day 30. If this criterion is not met, proceed to the next criterion. 3. Persistent renal dysfunction: on Day 30, the participant's serum creatinine level reaches or exceeds twice the baseline value.
14 secondary outcomes
Mean filter lifespan
Time frame: From first CRRT initiation to last CRRT discontinuation within 30 days after randomization
CRRT-free days through Day 30
Time frame: From randomization to day 30
All-cause mortality by Day 30
Time frame: From randomization to day 30
New or Ongoing Renal Replacement Therapy
Time frame: Days 27-33 after randomization
Persistent Renal Dysfunction at Day 30
Time frame: Day 30 after randomization
ICU mortality
Time frame: To be evaluated up to 30 days post randomization
In-hospital mortality
Time frame: To be evaluated up to 30 days post randomization
ICU length of stay
Time frame: To be evaluated up to 30 days post randomization
Hospital length of stay
Time frame: To be evaluated up to 30 days post randomization
Duration of CRRT
Time frame: From first CRRT initiation to last CRRT discontinuation within 30 days after randomization
Major Bleeding Events
Time frame: From randomization to day 30
New Bloodstream Infection During ICU Stay
Time frame: During ICU stay within 30 days after randomization
SOFA scores on Days 1, 3, 7, 14, and 30
Time frame: From randomization to day 30
Total number of filters used during CRRT
Time frame: From randomization to day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yingzi Huang principal investigator
Zhongda Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Citrate anticoagulation and Nafamostat Mesylate in people with Sepsis and Acute Kidney Injury, run by Jianfeng Xie.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiwen Zhang (+86 025-83262750, xiwen_zhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Kidney Events at Day 30 (MAKE30) (time frame: From randomization to day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.