UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005981 |
|---|---|
| Receipt number | 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 16:53:31 |
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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 ≥ 30mL/min/1.73 m2 and eGFR ≤ 50mL/min/1.73 m2 and urinary albumin to urinary creatinine ratio ≥ 300mg/g·creatinine at the enrollment
2) Outpatient
3) Age ≥ 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
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
Sponsor or person
Institute
Kanazawa Medical University Diabetes and Endocrinology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007024
