UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004784 |
|---|---|
| Receipt number | 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 17:48:14 |
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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
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
imasawa@cehpnet.com
Sponsor or person
Institute
National Hospital Organization Chiba-East Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
Single case data URL
Value
https://center6.umin.ac.jp/ice/5659
