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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name