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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030071
Receipt No. R000034336
Scientific Title Effects of complications on onset of nonfatal events and life prognosis in patients with chronic kidney disease
Date of disclosure of the study information 2017/11/22
Last modified on 2019/05/20

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Basic information
Public title Effects of complications on onset of nonfatal events and life prognosis in patients with chronic kidney disease
Acronym Effects of complications on onset of nonfatal events and life prognosis in patients with chronic kidney disease
Scientific Title Effects of complications on onset of nonfatal events and life prognosis in patients with chronic kidney disease
Scientific Title:Acronym Effects of complications on onset of nonfatal events and life prognosis in patients with chronic kidney disease
Region
Japan

Condition
Condition Chronic kidney disease(CKD)
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of the effects of complications of patients with CKD (eg, abnormal bone mineral metabolism, anemia, cardiovascular disease, nutritional disorder) and abnormal laboratory test values on the onset, life prognosis, and rate of decline in renal function of patients' nonfatal events
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To determine the effects of bone and mineral disorders and anemia on nonfatal events and life prognosis in patients with chronic kidney disease
Key secondary outcomes Relationship between clinical laboratory abnormalities in patients with CKD and rate of decline in renal function, nutritional status

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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Chronic kidney disease patients who are visiting our hospital regularly
Key exclusion criteria Patients complicated with serious diseases such as malignancy, heart failure (NYHA III degrees or more), and liver cirrhosis
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Michio
Middle name
Last name Kuwahara
Organization Saitama Tsukinomori Clinic
Division name Division of Nephrology
Zip code 339-0012
Address 366-1 Masunaga, Iwatsuki-ku, Saitama City, Saitama 339-0012, Japan
TEL 048-792-1811
Email kuwahara@k-naika-cl.jp

Public contact
Name of contact person
1st name Michio
Middle name
Last name Kuwahara
Organization Saitama Tsukinomori Clinic
Division name Division of Nephrology
Zip code 339-0012
Address 366-1 Masunaga, Iwatsuki-ku, Saitama City, Saitama 339-0012, Japan
TEL 048-792-1811
Homepage URL
Email kuwahara@k-naika-cl.jp

Sponsor
Institute Saitama Tsukinomori Clinic
Institute
Department

Funding Source
Organization Saitama Tsukinomori Clinic
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The Ethics Committee of Saitama Tsukinomori Clinic
Address 366-1 Masunaga, Iwatsuki-ku, Saitama City, Saitama 339-0012, Japan
Tel 0487921811
Email hayama@k-naika-cl.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
2017 Year 11 Month 22 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
2017 Year 11 Month 19 Day
Date of IRB
2017 Year 11 Month 20 Day
Anticipated trial start date
2017 Year 11 Month 22 Day
Last follow-up date
2027 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a prospective observational study. Among the patients that visit the Division of Nephrology of Saitama Tsukinomori Clinic after November 22, 2017, all patients that fulfilled the inclusion criteria will be enrolled in this study.

Management information
Registered date
2017 Year 11 Month 21 Day
Last modified on
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034336

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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