UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	What is the best biomarker to predict acute kidney injury during living donor renal transplantation, a single center experience.
Title of the study (Brief title)	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	Rikizo Kogawa
Organization	Toho University School of Medicine
Division name	Department of Anesthesiology
Address	6-11-1 , Omori-Nishi Ota-ku , Tokyo 143-8541 , Japan
TEL	03-3762-4151
Email	rikizo.kogawa@med.toho-u.ac.jp

Public contact
Name of contact person	Rikizo Kogawa
Organization	Toho University School of Medicine
Division name	Department of Anesthesiology
Address	6-11-1 , Omori-Nishi Ota-ku , Tokyo 143-8541 , Japan
TEL	03-3762-4151
Homepage URL
Email	rikizo.kogawa@med.toho-u.ac.jp

Sponsor
Institute	Toho University School of Medicine , Department of Anesthesiology
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016626