UMIN-CTR Clinical Trial

Basic information
Public title	Cooperation system between hospital and pharmacy in chronic kidney disease
Acronym	Cooperation system between hospital and pharmacy in chronic kidney disease
Scientific Title	Cooperation system between hospital and pharmacy in chronic kidney disease
Scientific Title:Acronym	Cooperation system between hospital and pharmacy in chronic kidney disease
Region	Japan

Condition
Condition	chronic kidney disease
Classification by specialty	Nephrology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of CKD patients instruction on medication adherence
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	medication adherence
Key secondary outcomes	ambulatory rate of medical record, blood pressure, blood sugar, HbA1c, nonHDL-C, Cr, eGFR, patient satisfaction

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	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	usual medical instruction
Interventions/Control_2	medical instruction with information of CKD
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	1. CKD patients 2. patients who can attend this hospital 3. patients who had already used the attend pharmacy 4. patients who understand this study
Key exclusion criteria	1. patients who can not understand this study 2. patient who will move to ohter hospital
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kunihiro Middle name Last name Yamagata
Organization	University of Tsukuba, Division of clinical medicine, Faculty of medicine
Division name	Department of nephrology
Zip code	305-8575
Address	1-1-1, Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-3202
Email	k-yamaga@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Chie Middle name Last name Saito
Organization	University of Tsukuba, Division of clinical medicine, Faculty of medicine
Division name	Department of nephrology
Zip code	305-8575
Address	1-1-1, Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-3202
Homepage URL
Email	chie.saito@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba Hospital
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tsukuba Clinical Research and Development Organization
Address	2-1-1,Amakubo, Tsukuba, Ibaraki, Japan
Tel	029-853-3914
Email	chiken@un.tsukuba.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	筑波大学附属病院（茨城県）、調剤薬局（茨城県つくば市）

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 27 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	No longer recruiting
Date of protocol fixation	2012 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date	2013 Year 06 Month 30 Day
Last follow-up date	2014 Year 06 Month 30 Day
Date of closure to data entry	2014 Year 09 Month 30 Day
Date trial data considered complete	2014 Year 09 Month 30 Day
Date analysis concluded	2014 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2012 Year 12 Month 27 Day
Last modified on	2019 Year 07 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011327