UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The impact of coversion of dialysate calcium concentration from either 2.5 mEq/L or 3.0 mEq/L to 2.75 mEq/L on mineral and bone disorders in maintenance hemodialysis patients: the K4 Study
Title of the study (Brief title)	the K4 Study
Region	Japan

Condition
Condition	Endstage Kidney Disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the best dialysate calcium concentration in maintenance hemodialysis patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Amount of intradialytic calcium elimination
Key secondary outcomes	Serum levels of calciuim, phosphate, and parathyroid hormone

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	2.75 mEq/L calcium dialysate
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	80 years-old >
Gender	Male
Key inclusion criteria	Maintenance hemodialysis patients treated with either 2.5 mEq/L or 3.0 mEq/L calcium dialysate
Key exclusion criteria	Female
Target sample size	24

Research contact person
Name of lead principal investigator	Masatomo Taniguchi
Organization	Fukuoka Renal Clinic
Division name	Division of Nephrology
Address	4-6-20 Watanabe-dori, Chuo-ku, Fukuoka 810-0004, Japan
TEL	092-761-4936
Email	ana65641@nifty.com

Public contact
Name of contact person	Masatomo Taniguchi
Organization	Fukuoka Renal Clinic
Division name	Division of Nephrology
Address	4-6-20 Watanabe-dori, Chuo-ku, Fukuoka 810-0004, Japan
TEL	092-761-4936
Homepage URL
Email	ana65641@nifty.com

Sponsor
Institute	Fukuoka Renal Clinic
Institute
Department

Funding Source
Organization	Fukuoka Renal Clinic, Japan Red Cross Fukuoka Hospital, Steel Memorial Yawata Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Japanese Red Cross Fukuoka Hospital, Steel Memorial Yawata Hospital
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	2012-10
Org. issuing International ID_1	Fukuoka Red Cross Hospital
Study ID_2	24-12
Org. issuing International ID_2	Steel Memorial Yawata Hospital
IND to MHLW

Institutions
Institutions	福岡赤十字病院(福岡県),製鉄記念八幡病院(福岡県)

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 01 Day
Anticipated trial start date	2012 Year 12 Month 01 Day
Last follow-up date	2018 Year 08 Month 31 Day
Date of closure to data entry	2018 Year 09 Month 01 Day
Date trial data considered complete	2018 Year 10 Month 31 Day
Date analysis concluded	2018 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Conversion of dialysate calcium concentration from 2.5 mEq/L to 2.75 mEq/L decreased intradialytic calcium elimination, while conversion of dialysate calcium concentration from 3.0 mEq/L to 2.75 mEq/L decreaed intradialytic calcium loading in maintenance hemodialysis patients
Other related information

Management information
Registered date	2018 Year 12 Month 08 Day
Last modified on	2018 Year 12 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040105