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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004784
Receipt No. R000005659
Scientific Title Prospective observational study to establish a method to predict the outcome of CKD patients by combined medical information by interview, imaging, and pathological findings
Date of disclosure of the study information 2011/01/01
Last modified on 2016/12/26

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Basic information
Public title Prospective observational study to establish a method to predict the outcome of CKD patients by combined medical information by interview, imaging, and pathological findings
Acronym Prediction of renal outcome by nephron number estimated in CKD patients (PRONEP)
Scientific Title Prospective observational study to establish a method to predict the outcome of CKD patients by combined medical information by interview, imaging, and pathological findings
Scientific Title:Acronym Prediction of renal outcome by nephron number estimated in CKD patients (PRONEP)
Region
Japan

Condition
Condition Chronic Kidney Disease (CKD)
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish a method to predict the outcome of CKD patients by estimating nephron number by combined medical information from interview, imaging, and pathological findings
Basic objectives2 Others
Basic objectives -Others Prospective observational study
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Primary end-point (composite end-point): total mortality, renal death, cerebro-cardiovascular event (ischemic heart disease, cerebral hemorrhage, cerebral infarction), 50% reduction in eGFR
Key secondary outcomes decline rate of eGFR

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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria CKD patients received renal biopsy (Informed concent should be obtained before renal biopsy. If impossible, IC obtained until one month after renal biopsy can be available)
Key exclusion criteria 1. Unilateral kidney, severe unilateral kidney atrophy, functionally unilateral kidney
2.patients with malignancy (if they are free over one year without no medication to the malignant disease, they are possible to attend this study)
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Imasawa
Organization National Hospital Organization Chiba-East Hospital
Division name Division of Nephrology, Diabetes, and Endocrinology
Zip code
Address 673 Nitona-cho Chuoh-ku Chiba-city, Chiba 260-8712, Japan
TEL 043-261-5171
Email imasawa@cehpnet.com

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyuki Imasawa
Organization National Hospital Organization Chiba-East Hospital
Division name Division of Nephrology, Diabetes, and Endocrinology
Zip code
Address 673 Nitona-cho Chuoh-ku Chiba 260-8712, Japan
TEL 043-261-5171
Homepage URL
Email imasawa@cehpnet.com

Sponsor
Institute National Hospital Organization Chiba-East Hospital
Institute
Department

Funding Source
Organization National Hospital Organization
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 国立病院機構北海道医療センター、国立病院機構千葉東病院、国立病院機構金沢医療センター、国立病院機構大阪医療センター、国立病院機構大阪南医療センター、国立病院機構京都医療センター、国立病院機構九州医療センター、国立病院機構福岡南医療センター、国立病院機構長崎医療センター

Other administrative information
Date of disclosure of the study information
2011 Year 01 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 Completed
Date of protocol fixation
2010 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information <Data at registration>
1) The interview information (age at renal biopsy, sex, height, birth weight, gestational age, body weight at 20-year-old, current body weight, CKD family history, family history of hypertension or diabetes mellitus, prescription of blocker of renin-angiotensin-aldosterone system
2) imaging information of kidney (long and short axis diameter of the biopsied-side kidney by echogram)
3) renal biopsy information (date, blood pressure, biopsied-side, needle gauge, total length of the cortex in the sample, the total number of glomeruli, total glomerular sclerosis number, pathological diagnosis)
4) laboratory findings (test-date, serum creatinine, serum cystatin C, HbA1c, uric acid level, serum LDL, urinary protein as protein/creatinine ratio (spot urine), 24-hour creatinine clearance, 24-hour protein excretion in urine

< Follow-up data >
Information for the evaluation will be collected once every year after renal biopsy. Data collection continued until March 31, 2016.
1) The death of individual, renal death, cerebrocardiovascular events and the turning point (death or survival), 50% reduction of eGFR
2) serum creatinine (the date of inspection), body weight, urinary protein as protein/creatinine ratio (spot urine), prescription of blocker of renin-angiotensin-aldosterone system
3) If no data is tracking, patient outcomes should be informed (stop of visiting at hospital, transfer to another hospital, moving house, and offer by patient to stop visiting)
* In this study, ischemic heart disease and cerebro-vascular disease are included,

Management information
Registered date
2010 Year 12 Month 22 Day
Last modified on
2016 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005659

Research Plan
Registered date File name
2016/12/26 改訂研究実施計画書(NHO腎)MRI有.docx

Research case data specifications
Registered date File name
2016/12/26 最終版・登録フォーム.pdf

Research case data
Registered date File name
2016/12/26 最終版・登録フォーム.xls


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