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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023724
Receipt No. R000026467
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
Date of disclosure of the study information 2016/08/24
Last modified on 2019/04/08

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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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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