UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective randomized controlled study of CRRT hemofilters for the treatment of acute kidney injury (AKI)
Title of the study (Brief title)	Prospective randomized controlled study of CRRT hemofilters for the treatment of acute kidney injury (AKI)
Region	Japan

Condition
Condition	Acute kidney injury (AKI)
Classification by specialty	Nephrology Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the clinical effects of CRRT hemofilters with different membrane materials and sizes for the treatment of acute kidney injury.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	28-day mortality
Key secondary outcomes	60-day mortality. Changes of SOFA score at 3 and 7 days after CRRT. Changes of plasma IL-6 levels at 1, 3, and 7 days after CRRT. Changes of lactate levels at 1, 3, and 7 days after CRRT. ICU free-days at Day 28. RRT free-days at Day 28. Progression to ESRD requiring maintenance hemodialysis. (subgroup analysis) septic AKI and non-septic AKI. with and without endotoxin removal hemoperfusion therapy.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	CRRT with 1.8m2 PMMA hemofilter (HEMOFEEL CH-1.8W)
Interventions/Control_2	CRRT with 1.0m2 PMMA hemofilter (HEMOFEEL CH-1.0N)
Interventions/Control_3	CRRT with 1.0m2 Polysulfone hemofilter (EXCELFLO AEF-10)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	AKI patients (AKIN criteria stage 1 or more) who required CRRT in ICU
Key exclusion criteria	- age less than 18 - pregnant women - chronic hemodialysis patients or patients who received RRT before randomization - end stage cancer patients
Target sample size	60

Research contact person
Name of lead principal investigator	Takashi Shigematsu
Organization	Wakayama Medical University
Division name	Division of Nephrology, Department of Internal Medicine
Address	811-1 Kimiidera, Wakayama City, Wakayama, Japan
TEL	073-441-0639
Email	taki@wakayama-med.ac.jp

Public contact
Name of contact person	Shigeo Negi
Organization	Wakayama Medical University
Division name	Division of Nephrology, Department of Inerenal Medicine
Address	811-1 Kimiidera, Wakayama City, Wakayama, Japan
TEL	073-441-0639
Homepage URL
Email	shigeon@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Toray Industries, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 15 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2014 Year 12 Month 25 Day
Anticipated trial start date	2015 Year 01 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 04 Day
Last modified on	2016 Year 12 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018706