UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of efficacy of Kremezin in peripheral arterial disease patients with chronic kidney disease.
Acronym	Evaluation of efficacy of Kremezin in peripheral arterial disease patients with chronic kidney disease.
Scientific Title	Evaluation of efficacy of Kremezin in peripheral arterial disease patients with chronic kidney disease.
Scientific Title:Acronym	Evaluation of efficacy of Kremezin in peripheral arterial disease patients with chronic kidney disease.
Region	Japan

Condition
Condition	Peripheral arterial disease with chronic kidney disease
Classification by specialty	Cardiology Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	CAVI(Cardio-ankle vascular index)
Key secondary outcomes	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

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	Treatment with Kremezin (6g/day) for 12 month
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	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
Key exclusion criteria	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
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Takayasu Ohtake
Organization	Shonan Kamakura General Hospital
Division name	Department of Nephrology, Immunology & Vascular Medicine
Zip code
Address	1370-1 Okamoto, Kamakura, Kanagawa
TEL	0467-46-1717
Email	ohtake@shonankamakura.or.jp

Public contact
1st name of contact person	1st name Middle name Last name Tomoko Machida
Organization	Mirai Iryo Research Center Inc,
Division name	Clinical Research Promotion Dept.
Zip code
Address	Emina Building 3F, 1-8-7, Koji-machi, Chiyoda-ku, Tokyo, Japan 102-0083
TEL	03-3263-4801
Homepage URL	http://www.mirai-iryo.com/
Email	machida@mirai-iryo.com

Sponsor
Institute	Shonan Kamakura General Hospital
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
Address
Tel
Email

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	湘南鎌倉総合病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 31 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	2014 Year 03 Month 11 Day
Date of IRB	2014 Year 03 Month 20 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 09 Month 30 Day
Date analysis concluded	2018 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date	2014 Year 03 Month 31 Day
Last modified on	2019 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015732