UMIN-CTR Clinical Trial

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
Email	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
Email	sdbjr617@gmail.com

Sponsor
Institute	Department of Nephrology, Daimon Clinic for Internal Medicine, Nephrology and Dialysis
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053608