UMIN-CTR Clinical Trial

Basic information
Public title	The association between histological feature of kidney biopsy and prognosis of kidney transplant recipients and donors.
Acronym	The association between histological feature of kidney biopsy and prognosis of kidney transplant recipients and donors.
Scientific Title	The association between histological feature of kidney biopsy and prognosis of kidney transplant recipients and donors.
Scientific Title:Acronym	The association between histological feature of kidney biopsy and prognosis of kidney transplant recipients and donors.
Region	Japan

Condition
Condition	kidney transplant recipients and donors
Classification by specialty	Nephrology Surgery in general Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the relationship between histological injuries in renal transplant biopsy and clinical course of the recipients and donors.
Basic objectives2	Others
Basic objectives -Others	retrospective observational study
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	progression to end-stage renal disease or deterioration of renal function
Key secondary outcomes	mortality, rejection, infection, changes in estiamated glomeular filtration rate, cardiovascular event, malignancy, diastolic ventricular dysfunction, vascular calcification, post-transplant anemia, parathyroid function

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	The donors and the recipients who underwent kidney transplantation at Kyushu universtity from January 1, 2000 to June 25, 2012.
Key exclusion criteria	Patients who wish to not participate in the study or patients who were deemed inappropriate.
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Toshiaki Middle name Last name Nakano
Organization	Graduate school of Medical Sciences, Kyushu University
Division name	Department of Medicine and Clinical Science
Zip code	812-8582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	+81-92-642-5843
Email	nakano.toshiaki.455@m.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Yuta Middle name Last name Matsukuma
Organization	Graduate school of Medical Sciences, Kyushu University
Division name	Department of Medicine and Clinical Science
Zip code	812-8582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	+81-92-642-5843
Homepage URL	http://www.kcu.med.kyushu-u.ac.jp/index.html
Email	matsukuma.yuta.191@m.kyushu-u.ac.jp

Sponsor
Institute	Graduate school of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization	Graduate school of Medical Sciences, Kyushu University
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	Kyushu University, Department of Clinical Medicine and Science
Address	3-1-1, Maidashi, HIgashi-ku
Tel	092-642-5843
Email	matsukuma.yuta.191@m.kyushu-u.ac.jp

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	2012 Year 08 Month 01 Day

Related information
URL releasing protocol	http://www.kcu.med.kyushu-u.ac.jp/index.html
Publication of results	Partially published

Result
URL related to results and publications	http://www.kcu.med.kyushu-u.ac.jp/index.html
Number of participants that the trial has enrolled	600
Results	Post-tranplant anemia was associated with interstitial fibrosis in donor kidney
Results date posted	2022 Year 01 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2013 Year 09 Month 21 Day
Baseline Characteristics	Kidney transplant recipient
Participant flow	Obseervational study
Adverse events	None
Outcome measures	Anemia was related with renal fibrosis
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 03 Month 01 Day
Date of IRB	2012 Year 07 Month 05 Day
Anticipated trial start date	2012 Year 07 Month 05 Day
Last follow-up date	2012 Year 07 Month 05 Day
Date of closure to data entry	2021 Year 12 Month 31 Day
Date trial data considered complete	2021 Year 12 Month 31 Day
Date analysis concluded	2021 Year 12 Month 31 Day

Other
Other related information	retrospective observational study

Management information
Registered date	2012 Year 07 Month 19 Day
Last modified on	2022 Year 01 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009951