Acute Kidney InjuryPhase 4NCT02478242
Trial to Assess the Efficacy and Safety of Nafamostat Mesilate During Continuous Renal Replacement Therapy
A Phase 4 study testing Nafamostat mesilate and Normal saline in people with Acute Kidney Injury, run by Kyungpook National University Hospital.
Trial summary
Randomized study to evaluate the efficacy and safety of nafamostat mesilate use during continuous renal replacement therapy in acute kidney injury patients at a high risk of bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Nafamostat mesilate and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were admitted to the intensive care unit and required CRRT
- active bleeding such as gastrointestinal bleeding and intracranial hemorrhage,
- activated partial thromboplastin time > 60 s,
- prothrombin time-international normalized ratio > 2.0,
- thrombocytopenia (<100,000/µL), and
- surgery within 48 h before CRRT.
Who cannot join
- Pregnant or possibly pregnant women
- Patients who were allergic to nafamostat mesilate
- Patients who were hypercoagulable
About this study
Randomized study to evaluate the efficacy and safety of nafamostat mesilate use during continuous renal replacement therapy in acute kidney injury patients at a high risk of bleeding.
Read the detailed description
Patients were randomly assigned to the nafamostat mesilate (NM) group or the no anticoagulant (NA) group. In patients assigned to the NM group, NM (20mg/h) was used for maintenance anticoagulation. Whereas, in patients assigned to the NA group, normal saline (2mL/h) was infused for continuous renal replacement therapy.
- Conditions
- Acute Kidney Injury
- Being tested
- Nafamostat mesilate, Normal saline
- 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.
Nafamostat mesilateDrug
Also called Futhan
nafamostat mesilate use for anticoagulation
Normal salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Nafamostat mesilate group | Active comparator | Nafamostat mesilate was used for maintenance anticoagulation during continuous renal replacement therapy. Receives: Drug: Nafamostat mesilate |
| No anticoagulation group | Placebo comparator | Normal saline was used for maintenance anticoagulation during continuous renal replacement therapy. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of filters used per hour
Measured: 24 months
Secondary outcomes (2)
Urea reduction ratio
Measured: 24 months
Survival rate
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startJul 2010
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chan-Duck Kim, M.D., Ph.D., Kyungpook National University Hospital
- Investigators
- Chan-Duck Kim, M.D., PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478242
- Sponsor's protocol ID
- KNUH_08-0023
- Status last verified
- Jun 2015
- First submitted
- 11 Jun 2015
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.
PubMed 33314078
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial to Assess the Efficacy and Safety of Nafamostat Mesilate During Continuous Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT02478242
- Acronym / sponsor ID
- KNUH_08-0023
- Conditions
- Acute Kidney Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Jun 2015 (estimated)
- 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.
Randomized study to evaluate the efficacy and safety of nafamostat mesilate use during continuous renal replacement therapy in acute kidney injury patients at a high risk of bleeding.
Detailed description
Patients were randomly assigned to the nafamostat mesilate (NM) group or the no anticoagulant (NA) group. In patients assigned to the NM group, NM (20mg/h) was used for maintenance anticoagulation. Whereas, in patients assigned to the NA group, normal saline (2mL/h) was infused for continuous renal replacement therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nafamostat mesilate group | Active comparator | Drug: Nafamostat mesilateNafamostat mesilate was used for maintenance anticoagulation during continuous renal replacement therapy. |
| No anticoagulation group | Placebo comparator | Drug: Normal salineNormal saline was used for maintenance anticoagulation during continuous renal replacement therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who were admitted to the intensive care unit and required CRRT
Key exclusion criteria (3 listed)
- Pregnant or possibly pregnant women
- Patients who were allergic to nafamostat mesilate
- Patients who were hypercoagulable
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 |
|---|---|---|
| Nafamostat mesilateAlso: Futhannafamostat mesilate use for anticoagulation | Drug | Nafamostat mesilate group |
| Normal saline | Drug | No anticoagulation group |
Primary outcome
Number of filters used per hour
Time frame: 24 months
2 secondary outcomes
Urea reduction ratio
Time frame: 24 months
Survival rate
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
- Derived from this study: PubMed 33314078Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.
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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. This study is not recruiting at the moment.
Chan-Duck Kim, M.D., PhD principal investigator
Associate Professor
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nafamostat mesilate and Normal saline in people with Acute Kidney Injury, run by Kyungpook National University Hospital.
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 6 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: finished, as of the sponsor's last update on 23 Jun 2015. 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. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of filters used per hour (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02478242, which also lists 1 linked publication.
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 23 Jun 2015.