Unique ID issued by UMIN | UMIN000023724 |
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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 |
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
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
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
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
Japan |
non-dialysis chronic kidney disease
Nephrology |
Others
NO
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.
Efficacy
Confirmatory
Pragmatic
Medication adherence
Serum creatinine
eGFR
indoxyl sulfate(Serum, 24 hour urine)
BUN
Urinany microalbumin
Urinany protein
NAG
B2-Mg
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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>
20 | years-old | <= |
Not applicable |
Male and Female
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
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
100
1st name | Daisuke |
Middle name | |
Last name | Nagata |
Jichi Medical University
Division of Nephrology
329-0431
3311-1 Yakushiji,Shimotsuke-shi,Tochigi-Ken
028-558-7346
nagatad@jichi.ac.jp
1st name | Hiromichi |
Middle name | |
Last name | Yoshizawa |
Jichi Medical University
Division of Nephrology
329-0431
3311-1 Yakushiji,Shimotsuke-shi,Tochigi-Ken
028-558-7346
zawa-52@jichi.ac.jp
Jichi Medical University
Mitsubishi Tanabe Pharma Corporation
Profit organization
Japan
Jichi Medical University Clinical Research Ethics Committee
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan
0285-58-8933
rinri@jichi.ac.jp
NO
自治医科大学(栃木県)
2016 | Year | 08 | Month | 24 | Day |
Unpublished
Completed
2016 | Year | 02 | Month | 25 | Day |
2016 | Year | 03 | Month | 22 | Day |
2016 | Year | 08 | Month | 24 | Day |
2018 | Year | 05 | Month | 31 | Day |
2018 | Year | 08 | Month | 28 | Day |
2018 | Year | 11 | Month | 12 | Day |
2018 | Year | 12 | Month | 28 | Day |
There is no other related information
2016 | Year | 08 | Month | 23 | Day |
2019 | Year | 04 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026467
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