UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046998 |
|---|---|
| Receipt number | R000053608 |
| Scientific Title | Relationship between metabolic acidosis and anemia |
| Date of disclosure of the study information | 2022/02/24 |
| Last modified on | 2022/02/24 21:59:58 |
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Basic information
Public title
Relationship between metabolic acidosis and anemia
Acronym
Relationship between metabolic acidosis and anemia
Scientific Title
Relationship between metabolic acidosis and anemia
Scientific Title:Acronym
Relationship between metabolic acidosis and anemia
Region
| Japan |
Condition
Condition
hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Oral sodium bicarbonate tablets and association with anemia To consider.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether Hb is increaseed or not
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Alkalizing agent sodium bicarbonate tablets were administered internally, and the relationship with anemia was examined.
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
| 56 | years-old | < |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with less than 0.5 g/dl variation in Hb levels.
Key exclusion criteria
Patients with high Hb levels variability of more than 0.6 g/dl.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Nishitani |
Organization
Department of Nephrology, Daimon Clinic for Internal Medicine, Nephrology and Dialysis
Division name
Clinical Engineering
Zip code
9218802
Address
1-400 oshino nonoichi ishikawa Japan
TEL
076-294-0066
sdbjr617@gmail.com
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Nishitani |
Organization
Department of Nephrology, Daimon Clinic for Internal Medicine, Nephrology and Dialysis
Division name
Clinical Engineering
Zip code
9218802
Address
1-400 oshino nonoichi ishikawa Japan
TEL
0762940066
Homepage URL
sdbjr617@gmail.com
Sponsor or person
Institute
Department of Nephrology, Daimon Clinic for Internal Medicine, Nephrology and Dialysis
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Nephrology, Daimon Clinic for Internal Medicine, Nephrology and Dialysis
Address
1-400 oshino nonoichi ishikawa Japan
Tel
0762940066
sdbjr617@gmail.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
| 2022 | Year | 02 | Month | 24 | 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
16
Results
The pH was 7.3885 before, 7.3893 after 5 weeks, and 7.3834 after 20 weeks of treatment with sodium bicarbonate. In contrast, HCO3 increased gradually from 22.661 before, to 24.431 after 5 weeks, and 25.563 after 20 weeks treatment with sodium bicarbonate (Table 2).
The Hb levels (primary endpoint) were almost unchanged (Figure 1).
Results date posted
| 2022 | Year | 02 | Month | 24 | Day |
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
| 2020 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 24 | Day |
Last modified on
| 2022 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053608
