UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015307 |
|---|---|
| Receipt number | R000017802 |
| Scientific Title | Clinical study of long-term prognosis of renal function after contrast media used examination and treatment (enhanced CT and angiography) |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2024/05/01 12:56:14 |
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Basic information
Public title
Clinical study of long-term prognosis of renal function after contrast media used examination and treatment (enhanced CT and angiography)
Acronym
Clinical study of long-term prognosis of renal function after contrast enhanced CT and angiography
Scientific Title
Clinical study of long-term prognosis of renal function after contrast media used examination and treatment (enhanced CT and angiography)
Scientific Title:Acronym
Clinical study of long-term prognosis of renal function after contrast enhanced CT and angiography
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is the evaluation of long-term renal function after contrast enhanced CT or angiography and investigation of prognostic factor of renal renal dysfunction.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The ratio of the patients with contrast induced nephropathy that show 0.5mg/dl or 25% increase of serum creatinine after 3 months and the ratio of the patients that show double score of serum creatinine or ESRD after one or two years
Key secondary outcomes
onset of renal cholesterol embolism, all cause death and exploratory investigation of risk factor of long-term prognosis of renal dysfunction
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with eGFR < 60ml/min/1.73m2 that will get angiography
patients with eGFR < 45ml/min/1.73m2 that will get contrast enhanced CT
Key exclusion criteria
patients with allergy to contrast media
dialysis patients
patients with hyperthyroidism
pregnant patients
patients with severe liver dysfunction
Target sample size
1080
Research contact person
Name of lead principal investigator
| 1st name | Hidekazu |
| Middle name | |
| Last name | Moriya |
Organization
Shonan Kamakura General Hospital
Division name
Blood purification center
Zip code
247-8533
Address
1370-1, Okamoto, Kamakura, Kanagawa
TEL
0467-46-1717
h_moriya@shonankamakura.or.jp
Public contact
Name of contact person
| 1st name | Hidekazu |
| Middle name | |
| Last name | Moriya |
Organization
Shonan Kamakura General Hospital
Division name
Blood purification center
Zip code
247-8533
Address
1370-1, Okamoto, Kamakura, Kanagawa
TEL
0467-46-1717
Homepage URL
h_moriya@shonankamakura.or.jp
Sponsor or person
Institute
Shonan Kamakura General Hospital
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
Mirai Iryo Research Center Inc.
Address
1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan
Tel
03-3263-4801
machida@mirai-iryo.com
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
| 2014 | Year | 10 | 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
| 2014 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 10 | Month | 06 | Day |
Other
Other related information
Finish the study
Management information
Registered date
| 2014 | Year | 10 | Month | 01 | Day |
Last modified on
| 2024 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017802
