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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005981
Receipt No. R000007024
Scientific Title Therapeutic effect by spherical oral adsorbent(Kremezin®) on vascular endothelial function in type 2 diabetic patients with overt nephropathy.
Date of disclosure of the study information 2011/07/15
Last modified on 2014/08/14

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Basic information
Public title Therapeutic effect by spherical oral adsorbent(Kremezin®) on vascular endothelial function in type 2 diabetic patients with overt nephropathy.
Acronym Therapeutic effect by spherical oral adsorbent(Kremezin®) on vascular endothelial function in type 2 diabetic patients with overt nephropathy.
Scientific Title Therapeutic effect by spherical oral adsorbent(Kremezin®) on vascular endothelial function in type 2 diabetic patients with overt nephropathy.
Scientific Title:Acronym Therapeutic effect by spherical oral adsorbent(Kremezin®) on vascular endothelial function in type 2 diabetic patients with overt nephropathy.
Region
Japan

Condition
Condition Type 2 diabetic patients with overt nephropathy.
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Therapeutic effect by spherical oral adsorbent(Kremezin®) on vascular endothelial function in type 2 diabetic patients with overt nephropathy is examined. The association between uremic toxin(i.e., indoxyl sulfate) and vascular endothelial function is examined as well.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Flow-mediated vasodilation(FMD)
Key secondary outcomes Changes of estimated GFR by Japanese equation, urinary protein to urinary creatinine ratio, parameters related to vascular endothelial function and atherosclerosis (i.e., ADMA, NOx, vWF), NT-proBNP, uremic toxin (i.e., indoxyl sulfate), and oxidative stress(urinary 8-OHdG).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Control group based on conventional treatment.
Interventions/Control_2 Treatment group based on Kremezin 6g per day(sachet or capsule) added to conventional treatment.
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 Inclusion criteria.
Type 2 diabetic patients with overt nephropathy and Patients that meet any of the following Inclusion Criteria may be enrolled into the study:
1) eGFR &#8805; 30mL/min/1.73 m2 and eGFR &#8804; 50mL/min/1.73 m2 and urinary albumin to urinary creatinine ratio &#8805; 300mg/g&#903;creatinine at the enrollment
2) Outpatient
3) Age &#8805; 20 years old and Age < 80 years old at the time of consent to participate in the study
4) Patients not required changes in anti-hypertensive medications or doses in the last 4 weeks prior to the enrollment
5) Patients being treated for hypertension(as anti-hypertensive regimen)
Patients who fully understand purpose, contents, anticipated adverse events , and risks of this clinical trial and patients with willingness to comply with the study and sign a written informed consent
Key exclusion criteria Exclusion Criteria
Patients that meet any of the following Exclusion Criteria must not be enrolled into the study:
1) Patients with transit disorder in the digestive tract or peptic ulcer and esophageal varix (this product may irritate affected area.) and patients whom physician judges as inappropriate
2) Patients with a predisposition to severe and habitual constipation (this product may exacerbate constipation) and patients whom physician judges as inappropriate
3) Patients with severe ketosis, diabetic coma, or precoma
4) Patients with severe infection, before and after operation, or severe injury
5) Patients with hematuria
6) Patients with a previous history of medication allergy
7) Patients who is currently pregnant, or plan to become pregnant during the study period
8) Patients with active diabetic proliferative retinopathy (except for patients with proliferative retinopathy who conducted retinal photocoagulation therapy and were stable on the retina)
9) Patients whom physician determines as inappropriate
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Koya
Organization Kanazawa Medical University Hospital
Division name Endocrinolgy and Metabolism
Zip code
Address Daigaku1-1 Uchinadamachi Kahokugun Ishikawa
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Koya
Organization Kanazawa Medical University Hospital
Division name Endocrinolgy and Metabolism
Zip code
Address Daigaku1-1 Uchinadamachi Kahokugun Ishikawa
TEL
Homepage URL
Email

Sponsor
Institute Kanazawa Medical University Diabetes and Endocrinology
Institute
Department

Funding Source
Organization Kanazawa Medical University and Endocrinology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 15 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
2011 Year 04 Month 08 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 07 Month 15 Day
Last modified on
2014 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007024

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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