UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003892 |
|---|---|
| Receipt number | R000004666 |
| Scientific Title | An examination of preventive effect of Carperitide for contrast induced nephropathy (CIN) in chronic kidney disease (CKD) patients |
| Date of disclosure of the study information | 2010/07/31 |
| Last modified on | 2010/07/08 19:24:28 |
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Basic information
Public title
An examination of preventive effect of Carperitide for contrast induced nephropathy (CIN) in chronic kidney disease (CKD) patients
Acronym
hANP for CIN in CKD
Scientific Title
An examination of preventive effect of Carperitide for contrast induced nephropathy (CIN) in chronic kidney disease (CKD) patients
Scientific Title:Acronym
hANP for CIN in CKD
Region
| Japan |
Condition
Condition
CKD with coronary artery disease
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate for efficacy of Carperitide for prevention of CIN after PCI or coronary angiography in CKD patients with coronary artery disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.acute and sub-acute renal injury after intervention or coronary angiography (chages of L-FABP, N-gal, Midkine, eGFR, urinary albumin, urinary creatinine and serum creatunine within 24h after contrast use)
2.renal injury at 48h and 7days after intervention or coronary angiography (changes of eGFR, urinary albumin, urinary creatinine, serum creatinine, L-FABP, N-gal, Midkine and cystatin C at 48h and 7days after contrast use)
Key secondary outcomes
incidence of adverse effects of Carperitide
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Carperitide group (intra-venous continuous injection of 0.025-0.05ug/kg/min 18-24h before and 6h after PCI or coronary angiography)
Interventions/Control_2
Control group (intra-venous continuous injection of 5% glucose 18-24h before and 6h after PCI or coronary angiography)
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
1.Patients with renal insufficiency (eGFR(mL/min/1.73m2)<60)
2.Patients with coronary artery disease
Key exclusion criteria
1.Patients with hemodialysis
2.cases with used contrast volume under 40ml, or over 300ml
3.Patients with previous adverse effect with Carperitide
4.female with pregnancy or possibility of pregnancy
5.Patients who judged that the medical attendant was inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mutsuharu Hayashi |
Organization
Nagoya university graduate school of medicine
Division name
Departmrnt of CKD initiatives
Zip code
Address
Turumai-tyo 65, syouwa-ku, Nagoya
TEL
052-744-5502
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mutsuharu Hayashi |
Organization
Nagoya university graduate school of medicine
Division name
Departmrnt of CKD initiatives
Zip code
Address
Turumai-tyo 65, syouwa-ku, Nagoya
TEL
052-744-5502
Homepage URL
muhayasi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Departmrnt of cardiology, Nagoya university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Departmrnt of cardiology, Nagoya university graduate school of medicine
Organization
Division
Category of Funding Organization
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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 08 | Day |
Last modified on
| 2010 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004666
