UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect and safety of conversion from Candesartan to Azilsartan in renal transplant recipeints
Title of the study (Brief title)	Conversion to Azilsartan in kidney trasnplant recipients
Region	Japan

Condition
Condition	hypertensive patient
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess beneficial effect and safety of convesrion from Azilsartan from Candesartan in renal translant patients with hypertension and proteinuria
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Urine protein before,3 months,6 months,and 12 months after the conversion
Key secondary outcomes	Blood pressure,albumin,creatinen,potasium,hemoglubin,plasma renin activity,plasma aldosterone concentarion and MCP-1 before,3 months,6 months,and 12 months after the conversion

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	20mg Azilsartan qd for 12wks,40mg qd for 40wks
Interventions/Control_2	8mg Candesartan qd for 52wks
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	Renal transplant recipients with grater than 200mg/day of urine protein despite of the treatment of 12mg Candesartan qd
Key exclusion criteria	1)Past medical history of hypersensitivity to azilsartan 2)Pregnant,lactating,and possibly pregnant women and those planning to become pregnant 3)Judged as ineligible by clinical investigators
Target sample size	40

Research contact person
Name of lead principal investigator	Yoichi Kakuta
Organization	Osaka University Greduate School of Medicine
Division name	Department of Urology
Address	2-2 E4 Yamada-oka,Suita,Osaka,Japan
TEL	06-6879-3531
Email	kakuta@uro.med.osaka-u.ac.jp

Public contact
Name of contact person	Yoichi Kakuta
Organization	Osaka University Greduate School of Medicine
Division name	Department of Urology
Address	2-2 E4 Yamada-oka,Suita,Osaka,Japan
TEL	06-6879-3531
Homepage URL
Email	kakuta@uro.med.osaka-u.ac.jp

Sponsor
Institute	Soryukai Inoue Hospital
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

Other administrative information
Date of disclosure of the study information	2012 Year 10 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 27 Day
Anticipated trial start date	2012 Year 10 Month 01 Day
Last follow-up date	2013 Year 10 Month 01 Day
Date of closure to data entry	2015 Year 05 Month 22 Day
Date trial data considered complete	2015 Year 05 Month 22 Day
Date analysis concluded	2015 Year 05 Month 22 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 09 Month 27 Day
Last modified on	2017 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010541