UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043714 |
|---|---|
| Receipt number | 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 | 2023/09/27 13:52:46 |
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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
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
yamamoto@shirasagi-hp.or.jp
Sponsor or person
Institute
Shirasagi Hospital
Institute
Department
Personal name
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
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
| Delay expected |
Results Delay Reason
Analysis of results has been delayed due to the author's illness treatment.
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
| 2023 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049912
