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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028177
Receipt No. R000032261
Scientific Title The investigation of mineral and bone disorder in patients with chronic kidney disease
Date of disclosure of the study information 2017/07/12
Last modified on 2017/07/11

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Basic information
Public title The investigation of mineral and bone disorder in patients with chronic kidney disease
Acronym MBD-N
Scientific Title The investigation of mineral and bone disorder in patients with chronic kidney disease
Scientific Title:Acronym MBD-N
Region
Japan

Condition
Condition Chronic kidney disease
Classification by specialty
Medicine in general Nephrology Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the influence on mineral and bone disorder on patients with chronic kidney disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Mortality
Key secondary outcomes Bone and cardiovascular changes - Fracture, bone mineral density, markers of bone metabolism, X-ray, cardiovascular disease, ABI, PWV, and renal impairment. Related factors - [MBD: Ca, P, PTH, VitD, FGF23, Klotho, and ucOC] [Anemia and iron: CBC, ferritin, TST, hepcidine, and frataxin] [Inflammation: hCRP, IL-6, and TNF alpha] [Oxidative stress: anti-oxidative activity, bilirubin, 8OHdG, and AOPP] [Others: uremic toxins and therapy (VDRA, phosphate binders, calcimimetics, and drugs for treatment of osteoporosis and the others)]. These are evaluated each 6 months.


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 Patients with chronic kidney disease (including renal transplant recipients).
Key exclusion criteria The patients who dose not agree with this study. The patients who are unsuitable for this study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Nakanishi
Organization Hyogo College of Medicine
Division name Dep Internal Medicine, Div Kidney and Dialysis
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798456521
Email jin@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukiko Hasuike
Organization Hyogo College of Medicine
Division name Dep Internal Medicine, Div Kidney and Dialysis
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798456521
Homepage URL
Email cherry39@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 兵庫医科大学病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 12 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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 12 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A prospective observational study

Management information
Registered date
2017 Year 07 Month 11 Day
Last modified on
2017 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032261

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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