UMIN-CTR Clinical Trial

Basic information
Public title	Mineral and Bone Disorder-New EXecute Trial
Acronym	MBD-NEXT
Scientific Title	Mineral and Bone Disorder-New EXecute Trial
Scientific Title:Acronym	MBD-NEXT
Region	Japan

Condition
Condition	Hyperphosphatemia under maintenance hemodialysis
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aims of this study are to describe variations in patient profiles and practice patterns (pharmacotherapies, non-pharmacotherapies, dialysis treatment and laboratory data), and to analyze the causes of variation in practice patterns, and to identify practice patterns and other factors related to patient outcomes.
Basic objectives2	Others
Basic objectives -Others	1) Relationship between calcimimetics treatment and outcomes 2) Relationship between MBD parameters and outcomes 3) Relationship between calcimimetics treatment and MBD
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Mortality, cardiovascular mortality, hospitatization, lower limb intervention, anemia, vascular access, etc.
Key secondary outcomes	Laboratory data and PROs (patient reported outcomes)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Maintenance hemodialysis patients who fulfill the following conditions 1) Patients who have given written informed consent 2) Patients with serum phosphate level of 3.5mg / dL or more or taking any phoshate binders.
Key exclusion criteria	Non
Target sample size	8000

Research contact person
Name of lead principal investigator	1st name Masafumi Middle name Last name Fukagawa
Organization	Japan chronic kidney disease - mineral bone disorder forum
Division name	Representative director
Zip code	259-1143
Address	143 Shimokasuya, Isehara-shi, Kanagawa
TEL	0463-93-1121
Email	mbd.next.du@kyowakirin.com

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Kirayama
Organization	JAPAN CONVENTION SERVICES,INC
Division name	Medical Department
Zip code	100-0013
Address	1-4-2 kasumigaseki, Chiyoda-ku, Tokyo
TEL	03-3508-1214
Homepage URL
Email	h-kira@convention.co.jp

Sponsor
Institute	Kyowa Kirin Co., Ltd.
Institute
Department

Funding Source
Organization	Kyowa Kirin Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institute for Health Outcomes and Process Evaluation Research (iHope International)
Address	5-513, Akinono-cho, Nakagyo-ku, Kyoto
Tel	075-211-5656
Email	research@i-hope.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 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	2019 Year 04 Month 19 Day
Date of IRB	2019 Year 05 Month 29 Day
Anticipated trial start date	2019 Year 05 Month 30 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The aims of this study are to describe variations in patient profiles and practice patterns (pharmacotherapies, non-pharmacotherapies, dialysis treatment and laboratory data), and to analyze the causes of variation in practice patterns, and to identify practice patterns and other factors related to patient outcomes.

Management information
Registered date	2020 Year 03 Month 27 Day
Last modified on	2020 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045558

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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