UMIN-CTR Clinical Trial

Basic information
Public title	Effects of dialysates on acidosis-related factors (EPO resistance, insulin resistance, and coronary calcification)in HD patients
Acronym	Effects of dialysates on HD patients
Scientific Title	Effects of dialysates on acidosis-related factors (EPO resistance, insulin resistance, and coronary calcification)in HD patients
Scientific Title:Acronym	Effects of dialysates on HD patients
Region	Japan

Condition
Condition	Chronic kidney disease stage 5D
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We compare the effects of 2 different dialysates on hemodialysis patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Coronary artery calcification (6 months and 12 months after initiation)
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Kindary 3E, Carbostar P
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Patients on hemodialysis 2)Being on hemodialysis for more than 12 weeks 3)Patients on hemodialysis with Kindary 3E 4)Aged between 20 and 80 years, either sex 5)Patients who are able to provide informed consent
Key exclusion criteria	1) Patients with arrhythmia or inability to hold their breath 2) Pregnant or lactating patients 3) Patients with severe liver disease (Child-Pugh score: 10 or more points) 4)Patients with anemia due to active bleeding 5)Diabetes patients treated with insulin 6)History of hospitalization for treatment within 12 weeks 7)Fever, or elevated CRP value (over the upper limit of institutional reference value) 8)Ejection fraction =<25%] 9) Patients after coronary artery angioplasty and stenting 10) Patients scheduled for coronary artery intervention or coronary artery bypass 11) Patients taking warfarin 12) Patients scheduled for parathyroidectomy or percutaneous ethanol injection therapy (PEIT). 13) Patients who received other study drugs or investigational drugs within 12 weeks 14) Patients judged unsuitable as research subjects
Target sample size	120

Research contact person
Last name of lead principal investigator	1st name Machiko Middle name Last name Oka
Organization	Shonan Fujisawa Tokushukai Hospital
Division name	Division of Nephrology
Zip code	251-0041
Address	1-5-1 Tsujido-Kandai, Fujisawa, Kanagawa
TEL	0466-35-1177
Email	machiko.oka@tokushukai.jp

Public contact
1st name of contact person	1st name Machiko Middle name Last name Oka
Organization	Shonan Fujisawa Tokushukai Hospital
Division name	Division of Nephrology
Zip code	251-0041
Address	1-5-1 Tsujido-Kandai, Fujisawa, Kanagawa
TEL	0466-35-1177
Homepage URL
Email	machiko.oka@tokushukai.jp

Sponsor
Institute	Shonan Fujisawa Tokushukai Hospital
Institute
Department

Funding Source
Organization	Self-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Shonankamakura General Hospital Shonanatsugi Hospital Hayama Heart Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Mirai iryo research center
Address	Emina building 3F Kojimachi 1-8-7 Chiyoda-ku, tokyo
Tel	03-3263-4801
Email	mirai-ec@mirai-iryo.com

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	2018 Year 11 Month 30 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	Open public recruiting
Date of protocol fixation	2018 Year 05 Month 14 Day
Date of IRB	2018 Year 05 Month 09 Day
Anticipated trial start date	2018 Year 09 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 11 Month 30 Day
Last modified on	2019 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036329