UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014279 |
|---|---|
| Receipt number | R000016623 |
| Scientific Title | The investigation of the renal protective effect of Carperitide(hANP:human atrial natriuretic peptide) during adult living donor renal transplantation, a single center experience. |
| Date of disclosure of the study information | 2014/06/16 |
| Last modified on | 2014/06/16 11:14:35 |
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Basic information
Public title
The investigation of the renal protective effect of Carperitide(hANP:human atrial natriuretic peptide) during adult living donor renal transplantation, a single center experience.
Acronym
The investigation of renal protective effect of Carperitide during adult living donor renal transplantation.
Scientific Title
The investigation of the renal protective effect of Carperitide(hANP:human atrial natriuretic peptide) during adult living donor renal transplantation, a single center experience.
Scientific Title:Acronym
The investigation of renal protective effect of Carperitide during adult living donor renal transplantation.
Region
| Japan |
Condition
Condition
living donor renal transplantation
Classification by specialty
| Nephrology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The investigation of the renal protective effect of Carperitide(hANP:human atrial natriuretic peptide) during adult living donor renal transplantation by measured the concentration of urinary liver-type fatty acid binding protein.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The concentrations of urinary liver-type fatty acid binding protein after renal transplantation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After the induction of general anesthesia, Carperitide or placebo drug(normal saline) was intravenously administrated at a rate of 0.025mcg/kg/min. We measured urinary liver-type fatty acid binding protein at preoperative period, immediately after the dissection of an ureter, postoperative period from the donor and the initial urine after the anastomosis, postoperative period, the day after the surgery from the recipient.
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 written informed consent
Key exclusion criteria
Patients without written informed consent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rikizo Kogawa |
Organization
Toho University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
6-11-1 , Omori-Nishi Ota-ku , Tokyo 143-8541 , Japan
TEL
03-3762-4151
rikizo.kogawa@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rikizo Kogawa |
Organization
Toho University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
6-11-1 , Omori-Nishi Ota-ku , Tokyo 143-8541 , Japan
TEL
03-3762-4151
Homepage URL
rikizo.kogawa@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University School of Medicine, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Daiichi-Sankyo Co
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
東邦大学医療センター大森病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 16 | 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
| 2008 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 16 | Day |
Last modified on
| 2014 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016623
