UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035184 |
|---|---|
| Receipt number | R000040105 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2018/12/08 22:07:52 |
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Basic information
Public title
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
Acronym
the K4 Study
Scientific Title
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
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Masatomo Taniguchi |
Organization
Fukuoka Renal Clinic
Division name
Division of Nephrology
Zip code
Address
4-6-20 Watanabe-dori, Chuo-ku, Fukuoka 810-0004, Japan
TEL
092-761-4936
ana65641@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masatomo Taniguchi |
Organization
Fukuoka Renal Clinic
Division name
Division of Nephrology
Zip code
Address
4-6-20 Watanabe-dori, Chuo-ku, Fukuoka 810-0004, Japan
TEL
092-761-4936
Homepage URL
ana65641@nifty.com
Sponsor or person
Institute
Fukuoka Renal Clinic
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
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
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
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040105
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
