Acute Kidney InjuryNEPHRONCT06150742
Nafamostat Efficacy in Phase 3 Registrational CRRT Study
A study testing Niyad (nafamostat mesylate) in people with Acute Kidney Injury, run by Talphera, Inc at 10 sites in United States.
Trial summary
A prospective, randomized, placebo-controlled clinical study to investigate the safety and efficacy of Niyad (nafamostat mesylate) for anticoagulation of extracorporeal blood circulating through a dialysis filter in patients undergoing CRRT who cannot tolerate heparin or are at higher risk for bleeding. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Niyad (nafamostat mesylate)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 10 sitesUnited States
- Study dates
- 15 Aug 2024to Dec 2025
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring CRRT or undergoing CRRT initiated within the prior 48 hours
- Patients who cannot tolerate heparin or are at high risk of bleeding
Who cannot join
- Patients weighing less than 50 kg
- Patients receiving systemic anticoagulation
- Patients with active bleeding
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chris Houchins contact
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
University of New Mexico
Albuquerque, New Mexico, 87131
Nurse Research Coordinator
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Clinical Research Coordinator
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Clinical Research Manager
- Recruiting
Baylor University Medical Center
Dallas, Texas, 75246
Research Nurse 1
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Clinical Study Coordinator
- Recruiting
Northwell Health
Great Neck, New York, 11021
Clinical Research Coordinator
- Recruiting
University of California Los Angeles
Los Angeles, California, 90095
Senior Clinical Research Associate
- Recruiting
Mount Sinai
New York, New York, 10029
Clinical Research Assistant
- Not yet recruiting
AdventHealth
Orlando, Florida, 32804
Program Manager Study Intake
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Assistant Director, Laboratory Operations
About this study
Official title: A Randomized, Placebo-controlled, Double-blind, Multi-center Study of the Safety and Efficacy of Niyad in Patients Undergoing Continuous Renal Replacement Therapy (CRRT) Who Cannot Tolerate Heparin or Are at a Higher Risk for Bleeding
A prospective, randomized, placebo-controlled clinical study to investigate the safety and efficacy of Niyad (nafamostat mesylate) for anticoagulation of extracorporeal blood circulating through a dialysis filter in patients undergoing CRRT who cannot tolerate heparin or are at higher risk for bleeding.
Read the detailed description
Patients in intensive care units with acute kidney injury are often too frail to undergo the rapid fluid shifts that accompany intermittent hemodialysis. Continuous renal replacement therapy (CRRT) allows a more gentle continual dialysis, more similar to regular kidney function. Anticoagulation of the CRRT circuit can reduce clotting of the filter, which can lead to less filter changes and possibly less transfusions. Niyad (nafamostat mesylate), an anticoagulant with an ultra-short half-life of 8 minutes, is approved for use in South Korea and Japan for anticoagulation of the CRRT circuit. For patients who cannot tolerate heparin or who are at a high risk of bleeding, nafamostat may be an optimal anticoagulant to infuse into the CRRT circuit as the short half-life should minimize patient exposure. The primary objective of this study is to measure the anticoagulation efficacy of Niyad in the CRRT circuit versus placebo. Evaluation of the safety of Niyad in patients undergoing CRRT versus placebo will also be performed.
- Conditions
- Acute Kidney Injury
- Being tested
- Niyad (nafamostat mesylate), Placebo (0.9% NaCl)
- Keywords
- continuous renal replacement therapy, anticoagulation
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niyad (nafamostat mesylate)Device
Niyad (nafamostat mesylate) lyophilized
Placebo (0.9% NaCl)Device
0.9% NaCl
| Study group | Role | What they receive |
|---|---|---|
| Niyad | Experimental | 1 mg/mL infusion of nafamostat mesylate Receives: Device: Niyad (nafamostat mesylate) |
| Placebo | Placebo comparator | 0.9% saline infusion Receives: Device: Placebo (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean post-filter activated clotting time (ACT)
mean post-filter activated clotting time (ACT)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start15 Aug 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Talphera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150742
- Sponsor's protocol ID
- NYD301
- Acronym
- NEPHRO
- Status last verified
- Oct 2024
- First submitted
- 21 Nov 2023
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, Multi-center Study of the Safety and Efficacy of Niyad in Patients Undergoing Continuous Renal Replacement Therapy (CRRT) Who Cannot Tolerate Heparin or Are at a Higher Risk for Bleeding
- ClinicalTrials.gov ID
- NCT06150742
- Acronym / sponsor ID
- NEPHRO / NYD301
- Conditions
- Acute Kidney Injury
- Keywords
- continuous renal replacement therapy, anticoagulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Talphera, IncIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Nov 2023 (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.
A prospective, randomized, placebo-controlled clinical study to investigate the safety and efficacy of Niyad (nafamostat mesylate) for anticoagulation of extracorporeal blood circulating through a dialysis filter in patients undergoing CRRT who cannot tolerate heparin or are at higher risk for bleeding.
Detailed description
Patients in intensive care units with acute kidney injury are often too frail to undergo the rapid fluid shifts that accompany intermittent hemodialysis. Continuous renal replacement therapy (CRRT) allows a more gentle continual dialysis, more similar to regular kidney function. Anticoagulation of the CRRT circuit can reduce clotting of the filter, which can lead to less filter changes and possibly less transfusions. Niyad (nafamostat mesylate), an anticoagulant with an ultra-short half-life of 8 minutes, is approved for use in South Korea and Japan for anticoagulation of the CRRT circuit. For patients who cannot tolerate heparin or who are at a high risk of bleeding, nafamostat may be an optimal anticoagulant to infuse into the CRRT circuit as the short half-life should minimize patient exposure. The primary objective of this study is to measure the anticoagulation efficacy of Niyad in the CRRT circuit versus placebo. Evaluation of the safety of Niyad in patients undergoing CRRT versus placebo will also be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Niyad | Experimental | Device: Niyad (nafamostat mesylate)1 mg/mL infusion of nafamostat mesylate |
| Placebo | Placebo comparator | Device: Placebo (0.9% NaCl)0.9% saline infusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients requiring CRRT or undergoing CRRT initiated within the prior 48 hours
- Patients who cannot tolerate heparin or are at high risk of bleeding
Key exclusion criteria (3 listed)
- Patients weighing less than 50 kg
- Patients receiving systemic anticoagulation
- Patients with active bleeding
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 |
|---|---|---|
| Niyad (nafamostat mesylate)Niyad (nafamostat mesylate) lyophilized | Device | Niyad |
| Placebo (0.9% NaCl)0.9% NaCl | Device | Placebo |
Primary outcome
mean post-filter activated clotting time (ACT)
Time frame: 24 hours
mean post-filter activated clotting time (ACT)
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 15 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Chris Houchins contact
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Niyad (nafamostat mesylate) in people with Acute Kidney Injury, run by Talphera, Inc at 10 sites in United States.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Nazneen Patel (647-724-5709 ext. 305, nazneen.patel@clinchoice.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean post-filter activated clotting time (ACT) (time frame: 24 hours). 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 15 Oct 2025.