Unique ID issued by UMIN | UMIN000013577 |
---|---|
Receipt number | R000015732 |
Scientific Title | Evaluation of efficacy of Kremezin in peripheral arterial disease patients with chronic kidney disease. |
Date of disclosure of the study information | 2014/03/31 |
Last modified on | 2019/04/03 18:11:27 |
Evaluation of efficacy of Kremezin in peripheral arterial disease patients with chronic kidney disease.
Evaluation of efficacy of Kremezin in peripheral arterial disease patients with chronic kidney disease.
Evaluation of efficacy of Kremezin in peripheral arterial disease patients with chronic kidney disease.
Evaluation of efficacy of Kremezin in peripheral arterial disease patients with chronic kidney disease.
Japan |
Peripheral arterial disease with chronic kidney disease
Cardiology | Nephrology |
Others
NO
To examine effects of Kremezin on arteriosclerosis using CAVI, peripheral artery calcification score, ABI, SPP, %FMD.
To examine the relationships between Kremezin and other factors including PDMP, insulin resistance, FGF-23, and IS.
Efficacy
Exploratory
Pragmatic
Not applicable
CAVI(Cardio-ankle vascular index)
1) Renal function: 1/sCr, eGFR
2) Marker: IS, FGF-23
3) Vascular function: PDMP, %FMD, ABI, SPP
4) Diagnostic imaging: pACS
5) Insulin resistance: HOMA-R
6) Safety: Adverse effect
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Treatment with Kremezin (6g/day) for 12 month
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) CKD: CKD stage G3a - G5
2) PAD: Fontaine classification I - II
3) Age 20 - 85 years old at the time of consent to participate in the study
4) Outpatient
5) Patients who have personally and voluntarily provided written informed consent, after having received and thoroughly understood an adequate explanation about participation in the study
1) Patients with diabetes
2) Patients who have newly taken NSAIDs during this study
3) Patients who have taken iodinated contrast medium or gadolinium contrast medium during entry period
4) Patients with major limb amputation
5) Patients with prior stroke and/or prior coronary artery disease
6) Patients with coronary stent by arteriosclerosis
7) Patients who have gastrointestinal obstruction
8) Patients who in currently pregnant, parturient, breast-feeding, or plan to become pregnant during the study period
9) Patients who are judged unsuitable for this study by the doctor in charge of the patients
40
1st name | |
Middle name | |
Last name | Takayasu Ohtake |
Shonan Kamakura General Hospital
Department of Nephrology, Immunology & Vascular Medicine
1370-1 Okamoto, Kamakura, Kanagawa
0467-46-1717
ohtake@shonankamakura.or.jp
1st name | |
Middle name | |
Last name | Tomoko Machida |
Mirai Iryo Research Center Inc,
Clinical Research Promotion Dept.
Emina Building 3F, 1-8-7, Koji-machi, Chiyoda-ku, Tokyo, Japan 102-0083
03-3263-4801
http://www.mirai-iryo.com/
machida@mirai-iryo.com
Shonan Kamakura General Hospital
Mitsubishi Tanabe Pharma Corporation
Profit organization
Japan
NO
湘南鎌倉総合病院(神奈川県)
2014 | Year | 03 | Month | 31 | Day |
Unpublished
Completed
2014 | Year | 03 | Month | 11 | Day |
2014 | Year | 03 | Month | 20 | Day |
2014 | Year | 04 | Month | 01 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 09 | Month | 30 | Day |
2018 | Year | 11 | Month | 30 | Day |
2014 | Year | 03 | Month | 31 | Day |
2019 | Year | 04 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015732
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |