UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000303 |
|---|---|
| Receipt number | R000000387 |
| Scientific Title | Romdomized study to evaluate the renoprotective effects of clarithromycin for diabetic patients with microalbuminuria. |
| Date of disclosure of the study information | 2005/12/30 |
| Last modified on | 2005/12/30 23:26:53 |
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Basic information
Public title
Romdomized study to evaluate the renoprotective effects of clarithromycin for diabetic patients with microalbuminuria.
Acronym
The study of the renoprotective effects of clarithromycin for diabetic nephropathy.
Scientific Title
Romdomized study to evaluate the renoprotective effects of clarithromycin for diabetic patients with microalbuminuria.
Scientific Title:Acronym
The study of the renoprotective effects of clarithromycin for diabetic nephropathy.
Region
| Japan |
Condition
Condition
Diabetic nephropathy
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the renoprotective effects of clarithromycin for diabetic patients with microalbuminuria
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary albumin excretion
Key secondary outcomes
1.Inflammatory marker
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is 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
In the clarythromycin group, claruthromycin will be prescribed at 200mg/day.
Interventions/Control_2
In control group, patients receive ordinary diet/excercise therapy and hypotensive agents including ACE inhibitor and ARB.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Diabetic patients with microalbuminuria (ACR(alb/Cr) is more than 100 microgram/mgCr, less than 300microgram/mgCr)
2.Diabetic duration is more than 5 years
Key exclusion criteria
1.CHF
2.Severe liver and/or kidney dysfunction
3.History of allergic response to drugs
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Shikata |
Organization
Okayama university graduate school of medicine, dentistry and pharmaceutical sciences
Division name
Department of medicine and clinical science
Zip code
Address
2-5-1 Shikata-cho, Okayama, 700-8558, Japan
TEL
086-235-7235
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Okayama university graduate school of medicine, dentistry and pharmaceutical sciences
Division name
Department of medicine and clinical science
Zip code
Address
TEL
086-235-7235
Homepage URL
Sponsor or person
Institute
Okayama university graduate school of medicine, dentistry and pharmaceutical sciences, Department of medicine and clinical science
Institute
Department
Personal name
Funding Source
Organization
Okayama university graduate school of medicine, dentistry and pharmaceutical sciences, Department of medicine and clinical science
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
| 2005 | Year | 12 | Month | 30 | 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
Date of protocol fixation
| 2005 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2005 | Year | 12 | Month | 30 | Day |
Last modified on
| 2005 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000387
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