UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028177 |
|---|---|
| Receipt number | 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 | 2021/04/16 11:26:52 |
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Basic information
Public title
The investigation of mineral and bone disorder in patients with chronic kidney disease
Acronym
MBD2
Scientific Title
The investigation of mineral and bone disorder in patients with chronic kidney disease
Scientific Title:Acronym
MBD2
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 | Yukiko |
| Middle name | |
| Last name | Hasuike |
Organization
Hyogo College of Medicine
Division name
Dep Internal Medicine, Div Kidney and Dialysis
Zip code
6638501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798456284
jin@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Hasuike |
Organization
Hyogo College of Medicine
Division name
Dep Internal Medicine, Div Kidney and Dialysis
Zip code
6638501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798456284
Homepage URL
cherry39@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
Hyogo College of Medicine
Address
1-1, Mukogawa-cho, Nishinomiya
Tel
0798456284
rinri@hyo-med.ac.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
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
| 2021 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2021 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032261
