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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035085
Receipt No. R000036329
Scientific Title Effects of dialysates on acidosis-related factors (EPO resistance, insulin resistance, and coronary calcification)in HD patients
Date of disclosure of the study information 2018/11/30
Last modified on 2019/05/31

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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
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
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

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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