UMIN-CTR Clinical Trial

Basic information
Public title	Effects of new dialysate for Japanese dialysis patients (K5) on serum electrolytes, acid-base balance, and calcium mass balance: A prospective multicenter clinical trial.
Acronym	the K5 Study
Scientific Title	Effects of new dialysate for Japanese dialysis patients (K5) on serum electrolytes, acid-base balance, and calcium mass balance: A prospective multicenter clinical trial.
Scientific Title:Acronym	the K5 Study
Region	Japan

Condition
Condition	End-stage kidney disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the clinical efficacy and validity of K5 in maintenance hemodialysis patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in serum potassium, calcium, magnesium, pH, bicarbonate, and glucose levels for one year
Key secondary outcomes	Calcium mass balance during dialysis

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	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Dialysate potassium 2.3 mEq/L, calcium 2.6 mEq/L, magnesium 1.2 mEq/L, bicarbonate 30 mEq/L, acetate 4.2 mEq/L, and glucose 150 mg/dL.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients undergoing dialysis 3 times a week for 4-6 hours using dialysate K4
Key exclusion criteria	Patients with liver dysfunction (serum AST or ALT >= 100 U/L) or cardiac function disorder (>= III of NYHA classification) or respiratory disorder (PO2 < 60 mmHg)
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Tadashi Middle name Last name Yamamoto
Organization	Shirasagi Hospital
Division name	Research Division
Zip code	546-0002
Address	7-11-23 Kumata, Higashisumiyoshi-ku, Osaka 546-0002, Japan
TEL	0667141661
Email	yamamoto@shirasagi-hp.or.jp

Public contact
Name of contact person	1st name Tadashi Middle name Last name Yamamoto
Organization	Shirasagi Hospital
Division name	Research Division
Zip code	546-0002
Address	7-11-23 Kumata, Higashisumiyoshi-ku, Osaka 546-0002, Japan
TEL	0667141661
Homepage URL
Email	yamamoto@shirasagi-hp.or.jp

Sponsor
Institute	Shirasagi Hospital
Institute
Department

Funding Source
Organization	Shirasagi Hospital, Date Clinic, Maeda Clinic
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Date Clinic, Maeda Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shirasagi Hospital, Ethics Committee
Address	7-11-23 Kumata, Higashisumiyoshi-ku, Osaka 546-0002, Japan
Tel	0667141661
Email	kidney@shirasagi-hp.or.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2010-010
Org. issuing International ID_1	Date Clinic
Study ID_2	M0052020
Org. issuing International ID_2	Maeda Clinic
IND to MHLW

Institutions
Institutions	だてクリニック（北海道）、前田医院（長崎県）

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 01 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	Enrolling by invitation
Date of protocol fixation	2020 Year 08 Month 01 Day
Date of IRB	2020 Year 08 Month 25 Day
Anticipated trial start date	2021 Year 03 Month 01 Day
Last follow-up date	2022 Year 04 Month 01 Day
Date of closure to data entry	2022 Year 06 Month 01 Day
Date trial data considered complete	2022 Year 07 Month 01 Day
Date analysis concluded	2022 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date	2021 Year 03 Month 23 Day
Last modified on	2021 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049912

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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