UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031900 |
|---|---|
| Receipt number | R000036424 |
| Scientific Title | PlGF/sFlt-1 and outcomes in CKD |
| Date of disclosure of the study information | 2018/03/27 |
| Last modified on | 2021/09/28 12:21:12 |
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Basic information
Public title
PlGF/sFlt-1 and outcomes in CKD
Acronym
PlGF/sFlt-1 and outcomes
Scientific Title
PlGF/sFlt-1 and outcomes in CKD
Scientific Title:Acronym
PlGF/sFlt-1 and outcomes
Region
| Japan |
Condition
Condition
CKD
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We shows PlGF/sFlt-1 as a useful predictor in CKD.
Basic objectives2
Others
Basic objectives -Others
We investigates whether PlGF/sFlt-1 is independently associated with cardiac and renal events in CKD patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cardiovascuar events
renal outcomes including end staging renal disease
renal anemia
all-cause mortality
cancer incidence
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
CKD criteria defined as an eGFR less than 60 mL/min or continuous proteinuria over 3 months
Key exclusion criteria
acute coronary syndrome within 3 months
malignancy within 5 years
acute kidney injury
pregnancy
Target sample size
1351
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Matsui |
Organization
Nara Medical University
Division name
Nephrology
Zip code
6348521
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
matsui-o-v2008420@olive.plala.or.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Matsui |
Organization
Nara Medical University
Division name
Nephrology
Zip code
6248521
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
matsui-o-v2008420@olive.plala.or.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
none
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
Nara Medical University
Address
840 Shijo-cho, Kashihara
Tel
0744-22-3051
matsui-o-v2008420@olive.plala.or.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
| 2018 | Year | 03 | Month | 27 | 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
Suspended
Date of protocol fixation
| 2004 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2005 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2004 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We are investigating the relation between PlGF/sFlt-1 and cardiac and renal events.
Management information
Registered date
| 2018 | Year | 03 | Month | 26 | Day |
Last modified on
| 2021 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036424
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
