UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective analysis of factors influencing long term outcome of kidney transplantation
Title of the study (Brief title)	Retrospective analysis of factors influencing long term outcome of kidney transplantation
Region	Japan

Condition
Condition	Chronic renal failure
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the factors which influence the longterm outcome of kidney transplantation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	patient survival and kidney graft survival
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	kidney transplant patients who were performed one-year protocol kidney graft biopsy
Key exclusion criteria	none
Target sample size	100

Research contact person
Name of lead principal investigator	Shiro Takahara
Organization	Osaka University
Division name	Advanced Technology for Transplantation
Address	2-2, J8, Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3746
Email	takahara@att.med.osaka-u.ac.jp

Public contact
Name of contact person	Naotsugu Ichimaru
Organization	Osaka University
Division name	Advanced Technology for Transplantation
Address	2-2, J8, Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3746
Homepage URL
Email	ichimaru@att.med.osaka-u.ac.jp

Sponsor
Institute	Department of Advanced Technology for Transplantation, Osaka University
Institute
Department

Funding Source
Organization	Astellas Pharma Inc.
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 15 Day
Anticipated trial start date	2013 Year 05 Month 20 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	Ten-year kidney graft survival was significantly deteriorated in de novo DSA-positive at the first year after kidney transplantation cases.

Management information
Registered date	2019 Year 03 Month 05 Day
Last modified on	2019 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012565