Acute Kidney Injury Requiring Continuous Renal Replacement TherapyPhase 2/3LIMITNCT06014801
Low-intensity Versus Medium-intensity Continuous Kidney Replacement Therapy for Critically Ill Patients
A Phase 2/3 study testing Dialysate fluid, Filtration replacement fluid in people with Acute Kidney Injury Requiring Continuous Renal Replacement Therapy, run by Jikei University School of Medicine at 9 sites in Japan.
Trial summary
This clinical trial aims to investigate whether the low treatment intensity (12 mL/kg/hr, low-dose hemodialysis/filtration) or the medium treatment intensity (25 mL/kg/hr, standard-dose hemodialysis/filtration) is more effective and safer for continuous renal replacement therapy in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury Requiring Continuous Renal Replacement Therapy
- What is being tested?
- Dialysate fluid, Filtration replacement fluid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 9 sitesJapan
- Study dates
- 30 Oct 2023to Jun 2030
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Patient who meets all of the following criteria and who has given informed consent.
- Adults (18 years of age or older, regardless of the time since ICU admission) currently admitted to an intensive care unit*. *Includes high care units, where continuous monitoring is conducted and intensive care physicians are in charge of medical care.
- A diagnosis of acute kidney injury is made according to the Kidney Disease: Improving Global Outcomes (KDIGO) international diagnostic criteria (one of the following is met)
- Serum creatinine increased by more than 0.3 mg/dL within 48 hours
- Serum creatinine increased more than 1.5-fold from baseline and the increase is considered to have occurred within 7 days
- Oliguria (< 0.5 mL/kg/hr) lasting more than 6 hours
- The treating intensivist believes that continuous kidney replacement therapy is necessary
Exclusion Criteria: Patient who meets any of the following exclusion criteria will be excluded.
- Receiving chronic dialysis or scheduled for initiation of chronic dialysis
- Undergoing any kidney replacement therapy or blood purification therapy within 48 hours
- When kidney replacement therapy using other dialysate or replacement fluids, such as citrate dialysis, is preferred due to coexisting bleeding disorders or allergy to acetate
- Concomitant blood purification therapy other than hemofiltration/dialysis, such as plasma exchange
- The patient is in a very critical condition and the treating physician believes that survival for more than 24 hours is unlikely
- Previous participation in the study
- After receiving a full explanation of the study and with full understanding, a patient do not consent to participate in the study of their own (or their substitute decision maker's) will.
- The principal investigator (or an investigator) thinks it to be inappropriate to participate in this study.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Japan9 sites, 9 recruiting
- Recruiting
University of Fukui Hospital
Fukui, 910 1193
Aiko Tanaka, MD, PhD, +81 776 61 3111
- Recruiting
Tsuchiura Kyodo General Hospital
Ibaraki, 300 0028
Akira Endo, MD, PhD, +81 29 830 3711
- Not yet recruiting
Osaka University Hospital
Osaka, 565 0871
Naoya Iguchi, MD, PhD, +81 6 6879 5111
- Recruiting
Sendai Medical Center
Sendai, Miyagi, 983-8520
Yu Kawazoe, MD, PhD, +81 22 293 1111, ukz411@gmail.com
- Recruiting
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka, 569-8686
Yu Amemiya, MD, +81 72 683 1221, yu.amemiya@ompu.ac.jp
- Recruiting
Jichi Medical University Hospital
Tochigi, 329 0498
Hisashi Imahase, MD
- Recruiting
Jikei University Hospital
Tokyo, 105 8471
Tomoko Fujii, MD, PhD, +81 3 3433 1111 ext. 4070, tofujii-tky@umin.net
- Recruiting
Keio University Hospital
Tokyo, 160 0016
Ryo Yamamoto, MD, PhD, +81 3 3353 1211
- Recruiting
Wakayama Medical University Hospital
Wakayama, 641 8509
Kyohei Miyamoto, MD, PhD, +81 73 447 2300
About this study
Official title: Low-Intensity Versus Medium-Intensity Continuous Kidney Replacement Therapy for Critically Ill Patients (LIMIT): A Multicenter Randomized Clinical Trial
This clinical trial aims to investigate whether the low treatment intensity (12 mL/kg/hr, low-dose hemodialysis/filtration) or the medium treatment intensity (25 mL/kg/hr, standard-dose hemodialysis/filtration) is more effective and safer for continuous renal replacement therapy in critically ill patients.
- Being tested
- Dialysate fluid, Filtration replacement fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialysate fluid, Filtration replacement fluidDrug
Dose of continuous hemodialysis and/or hemofiltration
| Study group | Role | What they receive |
|---|---|---|
| Low intensity | Experimental | 12 mL/kg/hr Receives: Drug: Dialysate fluid, Filtration replacement fluid |
| Medium intensity | Active comparator | 25 mL/kg/hr Receives: Drug: Dialysate fluid, Filtration replacement fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of death and duration of kidney replacement therapy at 28 days
Composite endpoint of death and duration of kidney replacement therapy at 28 days
Measured: 28 days or hospital discharge whichever comes first
Secondary outcomes (7)
ICU mortality
Measured: 90 days or hospital discharge whichever comes first
Hospital mortality
Measured: 90 days or hospital discharge whichever comes first
Dialysis dependence at hospital discharge
Measured: 90 days or hospital discharge whichever comes first
28-day vasopressor-free days
Measured: 28 days or hospital discharge whichever comes first
28-day ventilator-free days
Measured: 28 days or hospital discharge whichever comes first
Serum creatinine level at the end of kidney replacement therapy
Serum creatinine level on the day of final kidney replacement therapy and the day before
Measured: 90 days or hospital discharge whichever comes first
24-hour urine output at the end of kidney replacement therapy
24-hour urine output on the day of final kidney replacement therapy and the day before
Measured: 90 days or hospital discharge whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start30 Oct 2023
- Primary completionSep 2029 (estimated)
- Study completionJun 2030 (estimated)
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 Injury Requiring Continuous Renal Replacement TherapyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jikei University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Fukui, Tsuchiura Kyodo General Hospital, Keio University, Wakayama Medical University, Jichi Medical University, Sendai Medical Center, Osaka Medical and Pharmaceutical University Hospital
- Responsible party
- Principal investigator, Tomoko Fujii, Jikei University School of Medicine
- Investigators
- Tomoko Fujii, MD,PhD, Study chair, Jikei University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014801
- Sponsor's protocol ID
- JKI23-002
- Other IDs
- jRCTs031230292
- Acronym
- LIMIT
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Beaubien-Souligny W, Thompson Bastin M, Teixeira JP, Cerda J, Connor MJ Jr, Dijanic Zeidman A, Garimella PS, Juncos L, Lopez-Ruiz A, Mehta R, Reis T, Rizo-Topete L, Silver SA, Da Silva JR, Speer R, Vijayan A, Wells C, Wille K, Yessayan L, Tolwani A, Neyra JA. Proceedings of the University of Alabama at Birmingham Continuous Renal Replacement Therapy Academy (2023-2024): Managing De-Escalation of Acute Renal Replacement Therapy and Optimizing Drug Dosing during Renal Replacement Therapy Transitions. Kidney360. 2025 Oct 1;6(10):1798-1809. doi: 10.34067/KID.0000000951. Epub 2025 Aug 8.
PubMed 40779331
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Intensity Versus Medium-Intensity Continuous Kidney Replacement Therapy for Critically Ill Patients (LIMIT): A Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06014801
- Acronym / sponsor ID
- LIMIT / JKI23-002
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Jikei University School of MedicineUniversity, hospital or other
- Collaborators
- University of Fukui, Tsuchiura Kyodo General Hospital, Keio University, Wakayama Medical University, Jichi Medical University, Sendai Medical Center, Osaka Medical and Pharmaceutical University Hospital
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 28 Aug 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.
This clinical trial aims to investigate whether the low treatment intensity (12 mL/kg/hr, low-dose hemodialysis/filtration) or the medium treatment intensity (25 mL/kg/hr, standard-dose hemodialysis/filtration) is more effective and safer for continuous renal replacement therapy in critically ill patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low intensity | Experimental | Drug: Dialysate fluid, Filtration replacement fluid12 mL/kg/hr |
| Medium intensity | Active comparator | Drug: Dialysate fluid, Filtration replacement fluid25 mL/kg/hr |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Dialysate fluid, Filtration replacement fluidDose of continuous hemodialysis and/or hemofiltration | Drug | Low intensity, Medium intensity |
Primary outcome
Composite of death and duration of kidney replacement therapy at 28 days
Time frame: 28 days or hospital discharge whichever comes first
Composite endpoint of death and duration of kidney replacement therapy at 28 days
7 secondary outcomes
ICU mortality
Time frame: 90 days or hospital discharge whichever comes first
Hospital mortality
Time frame: 90 days or hospital discharge whichever comes first
Dialysis dependence at hospital discharge
Time frame: 90 days or hospital discharge whichever comes first
28-day vasopressor-free days
Time frame: 28 days or hospital discharge whichever comes first
28-day ventilator-free days
Time frame: 28 days or hospital discharge whichever comes first
Serum creatinine level at the end of kidney replacement therapy
Time frame: 90 days or hospital discharge whichever comes first
24-hour urine output at the end of kidney replacement therapy
Time frame: 90 days or hospital discharge whichever comes first
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 5 Aug 2026.
- Derived from this study: PubMed 40779331Beaubien-Souligny W, Thompson Bastin M, Teixeira JP, Cerda J, Connor MJ Jr, Dijanic Zeidman A, Garimella PS, Juncos L, Lopez-Ruiz A, Mehta R, Reis T, Rizo-Topete L, Silver SA, Da Silva JR, Speer R, Vijayan A, Wells C, Wille K, Yessayan L, Tolwani A, Neyra JA. Proceedings of the University of Alabama at Birmingham Continuous Renal Replacement Therapy Academy (2023-2024): Managing De-Escalation of Acute Renal Replacement Therapy and Optimizing Drug Dosing during Renal Replacement Therapy Transitions. Kidney360. 2025 Oct 1;6(10):1798-1809. doi: 10.34067/KID.0000000951. Epub 2025 Aug 8.
- Individual participant dataSharing planned: Yes
Related trials for Acute Kidney Injury Requiring Continuous Renal Replacement Therapy
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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.
Tomoko Fujii, MD,PhD study chair
Jikei University School of Medicine
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dialysate fluid, Filtration replacement fluid in people with Acute Kidney Injury Requiring Continuous Renal Replacement Therapy, run by Jikei University School of Medicine at 9 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Japan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Tomoko Fujii, MD,PhD (+81 3 3433 1111, tofujii-tky@umin.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of death and duration of kidney replacement therapy at 28 days (time frame: 28 days or hospital discharge whichever comes first). 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 NCT06014801, 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 5 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.