UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the safety on hemodiafilter "AMPA-01" in renal failure patients.
Acronym	Evaluation of the safety on AMPA-01.
Scientific Title	Evaluation of the safety on hemodiafilter "AMPA-01" in renal failure patients.
Scientific Title:Acronym	Evaluation of the safety on AMPA-01.
Region	Japan

Condition
Condition	Maintenance dialysis patients who are indicated for hemodiafiltration.
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of hemodiafiltration using "AMPA-01" in maintenance dialysis patients who are indicated for hemodiafiltration.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	1) The frequency of acute failure such as adverse events which is suspected to be caused by "AMPA-01". 2) Blood compatibility (Fluctuations in the number of white blood cells and platelets during hemodiafiltration.)
Key secondary outcomes	1) clearance 2) reduction rate 3) removal amount 4) protein leakage 5) transmembrane pressure

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Hemodiafiltration using AMPA-01
Interventions/Control_2
Interventions/Control_3
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Maintenance dialysis patients corresponding to - three times per week - more than three and a half hours in each dialysis session - hemodialysis or hemodiafiltration for more than six months - last one month received hemodiafiltration. 2) Qb 250 mL/min is possible when the effectiveness evaluation. 3) Outpatients. 4) Ability to give written informed consent. 5) Aged 20 to <80 years at the time of informed consent.
Key exclusion criteria	1) Need to blood purification other than AMPA-01. 2) With a medical history of anaphylaxis symptoms caused by polysulfone or polyvinylpyrrolidone (PVP). 3) Pregnant women or lactating mothers 4) With severe organ dysfunction other than kidney. 5) Patients who had participated in other clinical trial within the previous 6 months. 6) Judged ineligible by the attending physician.
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Middle name Last name HASHIMOTO Shinji
Organization	ASAHI KASEI MEDICAL CO., LTD.
Division name	Clinical Development Department
Zip code
Address	1-105 Kanda Jinbocho, Chiyoda-ku, Tokyo
TEL	03-3296-3787
Email	hashimoto.sg@om.asahi-kasei.co.jp

Public contact
Name of contact person	1st name Middle name Last name OHSHIMA Koji
Organization	ASAHI KASEI MEDICAL CO., LTD.
Division name	Clinical Development Department
Zip code
Address	1-105 Kanda Jinbocho, Chiyoda-ku, Tokyo
TEL	03-3296-3787
Homepage URL
Email	oshima.kb@om.asahi-kasei.co.jp

Sponsor
Institute	ASAHI KASEI MEDICAL CO., LTD.
Institute
Department

Funding Source
Organization	ASAHI KASEI MEDICAL CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW	平成27年4月13日

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 23 Day
Date of IRB
Anticipated trial start date	2015 Year 06 Month 08 Day
Last follow-up date	2015 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2015 Year 10 Month 20 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 06 Month 02 Day
Last modified on	2015 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020568

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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