臨床研究等提出・公開システム

Date of registration	May. 19, 2016
Last modified on	July. 30, 2020
Trial ID	jRCT2080223207

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

Completion Date or Terminated date	Sept. 27, 2017
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	FUSO Pharmaceutical Industries, Ltd.
	Address
	Phone Number
	E-mail Address	rinsyo@fuso-pharm.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	FUSO Pharmaceutical Industries, Ltd.
	Address
	Phone Number
	E-mail Address	rinsyo@fuso-pharm.co.jp

Recruitment Status	completed

Date of First Enrolment		April. 30, 2016
Target Sample Size		220
Study Type		Interventional
Study Design	Study Design	A multicenter, open-label, randomized, active-controlled, parallel-group study
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	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.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Acute kidney injury
Intervention(s)		investigational material(s) Generic name etc : FCU-08 INN of investigational material : - Therapeutic category code : 341 Agents for artificial kidney dialysis Dosage and Administration for Investigational material : Used as dialysate for continuous hemodialysis, substitution fluid for continuous hemofiltration, or dialysate and substitution fluid for continuous hemodiafiltration. control material(s) Generic name etc : Sublood-BSG INN of investigational material : - Therapeutic category code : 341 Agents for artificial kidney dialysis Dosage and Administration for Investigational material : Used as dialysate for continuous hemodialysis, substitution fluid for continuous hemofiltration, or dialysate and substitution fluid for continuous hemodiafiltration.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy confirmatory -
Secondary Outcome		safety efficacy -

Primary Sponsor	FUSO Pharmaceutical Industries, Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	-
Address of IRB	-
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	April. 06, 2016

Secondary ID No.	JapicCTI-163262
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
3	July. 30, 2020	(this page)	Changes
2	Oct. 02, 2017	Detail	Changes
1	May. 19, 2016	Detail

List of change history