UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014475 |
|---|---|
| Receipt number | R000016840 |
| Scientific Title | Significance of erythopoietin receptor antibody concentration in diabetes |
| Date of disclosure of the study information | 2014/07/07 |
| Last modified on | 2019/07/16 09:26:31 |
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Basic information
Public title
Significance of erythopoietin receptor antibody concentration in diabetes
Acronym
Erythopoietin receptor antibody in diabetes
Scientific Title
Significance of erythopoietin receptor antibody concentration in diabetes
Scientific Title:Acronym
Erythopoietin receptor antibody in diabetes
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study asesses the associatin between erythropoietin antibody and other autoimmune antibodies, anemia, glycemic control in diabtes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma concentration of erythopoietin antobodies
Key secondary outcomes
Factors which may affect plasma concentration of erythopoietin antobodies
1)GAD antibodies
2)Thyrogloblin (Tg) antibodies
3)Peroxidase (Pox) antibodies
4) HbA1c, fasting and post-prandial blood glucose, immnunoreactive insulin (IRI)
5) Age
6) Anemia (Hb, Hct, RBC)
7) eGFR, urinal albumin/ Crea, clinical stage for nephropathy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients with diabetes
2)Patients with written informed concent to the study
3)Age over 20 and under 80 at the time of registration
Key exclusion criteria
1)Patients with severe diabetic ketoacidosis or come within recent 6 month
2) Patents with severe infectious disease, peri-operation and severe trauma
3)Patients with pregnancy (possible pregnancy) or nursing.
4)Patients ineligible for some other medical reason by a physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Yamakawa |
Organization
Yokohama City University Medical Center
Division name
Department of Endocrinology and Diabetes
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
naibunpi@urahp.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Okamoto |
Organization
Yokohama City University Medical Center
Division name
Department of Endocrinology and Diabetes
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
yokamoto@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
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
横浜市立大学附属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 07 | 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
54
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 | 04 | Month | 15 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The present study asesses the associatin between erythropoietin antibody and other autoimmune antibodies, anemia, glycemic control in type1diabtes
Management information
Registered date
| 2014 | Year | 07 | Month | 04 | Day |
Last modified on
| 2019 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016840
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
