UMIN-CTR Clinical Trial

Basic information
Public title	The prevention of progression in CKD of medication adherence to AST-120 in patients with non-dialysis chronic kidney disease (CKD) and significance of measurement indoxyl sulfate as an indicator of medication adherence
Acronym	The prevention of progression in CKD of medication adherence to AST-120 in patients with non-dialysis chronic kidney disease (CKD) and significance of measurement indoxyl sulfate as an indicator of medication adherence
Scientific Title	The prevention of progression in CKD of medication adherence to AST-120 in patients with non-dialysis chronic kidney disease (CKD) and significance of measurement indoxyl sulfate as an indicator of medication adherence
Scientific Title:Acronym	The prevention of progression in CKD of medication adherence to AST-120 in patients with non-dialysis chronic kidney disease (CKD) and significance of measurement indoxyl sulfate as an indicator of medication adherence
Region	Japan

Condition
Condition	non-dialysis chronic kidney disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect by lowering indoxyl sulfate with AST-120 on prevention of progression in CKD. To examine medication adherence to treatment effect. To evaluate the efficacy of AST-120 in CKD by measurement indoxyl sulfate as an indicator of the medication adherence.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Medication adherence Serum creatinine eGFR indoxyl sulfate(Serum, 24 hour urine)
Key secondary outcomes	BUN Urinany microalbumin Urinany protein NAG B2-Mg

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The patient who is already taking AST-120 continues prescription of AST-120. The patient who does not take AST-120 starts prescription of AST-120<6g/day t.i.d. between meals>
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	1) Age is >=20 years and obtain written informed consent 2) eGFR<45ml/min/1.73mm2(CKD stage 3b, 4, 5) 3)non-peritoneal dialysis and non-hemodialysis
Key exclusion criteria	1) Patients with a gastrointestinal disorder 2) AFR,RPGN(acute phase), Advanced nephrotic syndrome (albumin<2g/dl), Transplanted kidney 3) Severe heart failure (NYHA3 or more),Serious arrhythmia, Myocardial infarction or PCI within 6 months. 4) T1DM,and T2DM 5) AST, ALT less than 5 times as much as upper limit of standard value. 6) progressive cancer 7) Pregnant or women of childbearing potential unwilling to use effective means of contraception. 8) Patients who cannot signed an informed consent 9) Allergy to AST-120 10) Any other medical conditions disable to comply with the protocol
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Daisuke Middle name Last name Nagata
Organization	Jichi Medical University
Division name	Division of Nephrology
Zip code	329-0431
Address	3311-1 Yakushiji,Shimotsuke-shi,Tochigi-Ken
TEL	028-558-7346
Email	nagatad@jichi.ac.jp

Public contact
1st name of contact person	1st name Hiromichi Middle name Last name Yoshizawa
Organization	Jichi Medical University
Division name	Division of Nephrology
Zip code	329-0431
Address	3311-1 Yakushiji,Shimotsuke-shi,Tochigi-Ken
TEL	028-558-7346
Homepage URL
Email	zawa-52@jichi.ac.jp

Sponsor
Institute	Jichi Medical University
Institute
Department

Funding Source
Organization	Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Jichi Medical University Clinical Research Ethics Committee
Address	3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan
Tel	0285-58-8933
Email	rinri@jichi.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	自治医科大学（栃木県）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 24 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	Completed
Date of protocol fixation	2016 Year 02 Month 25 Day
Date of IRB	2016 Year 03 Month 22 Day
Anticipated trial start date	2016 Year 08 Month 24 Day
Last follow-up date	2018 Year 05 Month 31 Day
Date of closure to data entry	2018 Year 08 Month 28 Day
Date trial data considered complete	2018 Year 11 Month 12 Day
Date analysis concluded	2018 Year 12 Month 28 Day

Other
Other related information	There is no other related information

Management information
Registered date	2016 Year 08 Month 23 Day
Last modified on	2019 Year 04 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026467