A randomized study of FCU-08 in patients with acute kidney injury requiring continuous blood purification therapy

Phase 3

Completed

• Conditions: Acute kidney injury

• Registration Number: JPRN-jRCT2080223207
• Lead Sponsor: FUSO Pharmaceutical Industries, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-19
• Study Completion: 2017-09-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

(1) Patients diagnosed with acute kidney injury
(2) Patients judged to need continuous renal replacement therapy by the investigator, etc.
(3) Patients aged 20 years or older at the time of informed consent
(4) Patients providing written informed consent about participation in this clinical trial by themselves, or legally acceptable representative if patients lack the ability of consent

Exclusion Criteria

(1) Patients with serum potassium level of more than 6.0 mEq/L at the time of enrollment
(2) Patients undergone intermittent hemodialysis, intermittent hemofiltration, intermittent hemodiafiltration more than once or continuous blood purification therapy for more than 24 hours between admission for illness caused acute kidney injury (including other hospitals) and enrollment
(3) Patients who have life-threatening bleeding symptoms or bleeding in regions where it is difficult to stop bleeding with cerebral hemorrhage, severe pulmonary hemorrhage, severe gastrointestinal hemorrhage, and multiple trauma complications, etc. at the time of enrollment
(4) Patients with chronic kidney disease undergoing hemodialysis
(5) Female patients who are pregnant or who have the possibility of pregnancy which cannot be denied by a pregnancy test at the time of enrollment
(6) Patients who can be confirmed the administration of other study drug (use of investigational device) within 12 weeks before the time of enrollment, or patients in another clinical study at the time of enrollment
(7) Patients judged to be inadequate by the investigator, etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>confirmatory<br>-

Secondary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>-