UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014282 |
|---|---|
| Receipt number | R000016626 |
| Scientific Title | What is the best biomarker to predict acute kidney injury during living donor renal transplantation, a single center experience. |
| Date of disclosure of the study information | 2014/06/16 |
| Last modified on | 2017/04/26 21:51:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
What is the best biomarker to predict acute kidney injury during living donor renal transplantation, a single center experience.
Acronym
The best biomarker during renal transplantation.
Scientific Title
What is the best biomarker to predict acute kidney injury during living donor renal transplantation, a single center experience.
Scientific Title:Acronym
The best biomarker during 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 biomarker to predict renal ischemic reperfusion injury during living donor renal transplantation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The concentrations of biomarkers during living donor renal transplantation . The measured biomarkers were included urinary L-FABP(liver-type fatty acid binding protein), urinary H-FABP(heart-type fatty acid binding protein), urinary NGAL(neutrophil gelatinase-associated lipocalin), urinary Lf(lactoferrin) and plasma IL-18(interleukin 18).
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with written informed consent(or by next of kin)
Key exclusion criteria
Patients without written informed consent(or by next of kin)
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
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
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
| 2012 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We measured the concentrations of biomarkers during living donor renal transplantation. The biomarkers were urinary L-FABP(liver-type fatty acid binding protein), urinary H-FABP(heart-type fatty acid binding protein), urinary NGAL(neutrophil gelatinase-associated lipocalin), urinary Lf(lactoferrin) and plasma IL-18(interleukin 18). The urine and blood samples were collected at preoperative period, postoperative period from the donor and the initial urine after the anastomosis, 5hours after the reperfusion, 24hours after the reperfusion, and the week after the surgery from the recipient.
Management information
Registered date
| 2014 | Year | 06 | Month | 16 | Day |
Last modified on
| 2017 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016626
