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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013577
Receipt No. 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

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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
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
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://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


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