UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039961
Receipt number R000045558
Scientific Title Mineral and Bone Disorder-New EXecute Trial
Date of disclosure of the study information 2020/04/01
Last modified on 2023/10/10 13:03:09

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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

8400


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 or person

Institute

Kyowa Kirin Co., Ltd.

Institute

Department

Personal name



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

8806

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Analysis has not yet been conducted due to the large amount of data and the time required for cleaning from the end of the follow-up period.
Analysis is currently under discussion and is expected to begin in 2024.

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

No longer recruiting

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

2022 Year 06 Month 30 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

2023 Year 10 Month 10 Day



Link to view the page

Value
https://center6.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