UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023724
Receipt number 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 10:35:28

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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 or person

Institute

Jichi Medical University

Institute

Department

Personal name



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

Value
https://center6.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