UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035085 |
|---|---|
| Receipt number | 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 13:21:37 |
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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
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
machiko.oka@tokushukai.jp
Sponsor or person
Institute
Shonan Fujisawa Tokushukai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036329
