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

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 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


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

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