NCT06014801 Low-intensity Versus Medium-intensity Continuous Kidney Replacement Therapy for Critically Ill Patients
| NCT ID | NCT06014801 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Jikei University School of Medicine |
| Condition | Acute Kidney Injury Requiring Continuous Renal Replacement Therapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-10-30 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 400 participants in total. It began in 2023-10-30 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: Patient who meets all of the following criteria and who has given informed consent. 1. 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. 2. 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 3. 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. 1. Receiving chronic dialysis or scheduled for initiation of chronic dialysis 2. Undergoing any kidney replacement therapy or blood purification therapy within 48 hours 3. 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 4. Concomitant blood purification therapy other than hemofiltration/dialysis, such as plasma exchange 5. The patient is in a very critical condition and the treating physician believes that survival for more than 24 hours is unlikely 6. Previous participation in the study 7. 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. 8. The principal investigator (or an investigator) thinks it to be inappropriate to participate in this study.
Contact & Investigator
Tomoko Fujii, MD,PhD
STUDY CHAIR
Jikei University School of Medicine
Frequently Asked Questions
Who can join the NCT06014801 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Kidney Injury Requiring Continuous Renal Replacement Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06014801 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06014801 currently recruiting?
Yes, NCT06014801 is actively recruiting participants. Contact the research team at tofujii-tky@umin.net for enrollment information.
Where is the NCT06014801 trial being conducted?
This trial is being conducted at Sendai, Japan, Takatsuki, Japan, Fukui, Japan, Ibaraki, Japan and 5 additional locations.
Who is sponsoring the NCT06014801 clinical trial?
NCT06014801 is sponsored by Jikei University School of Medicine. The principal investigator is Tomoko Fujii, MD,PhD at Jikei University School of Medicine. The trial plans to enroll 400 participants.
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