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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003892
Receipt No. 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

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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
Email

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
Email muhayasi@med.nagoya-u.ac.jp

Sponsor
Institute Departmrnt of cardiology, Nagoya university graduate school of medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004666

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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