UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039961
Receipt No. R000045558
Scientific Title Mineral and Bone Disorder-New EXecute Trial
Date of disclosure of the study information 2020/04/01
Last modified on 2020/03/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.