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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043714
Receipt No. R000049912
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.
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/23

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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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