UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000908 |
|---|---|
| Receipt number | R000000820 |
| Scientific Title | The Study of Throid and Iron-Sulfur states in CKD |
| Date of disclosure of the study information | 2007/11/28 |
| Last modified on | 2016/04/13 17:05:54 |
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Basic information
Public title
The Study of Throid and Iron-Sulfur states in CKD
Acronym
TIS study
Scientific Title
The Study of Throid and Iron-Sulfur states in CKD
Scientific Title:Acronym
TIS study
Region
| Japan |
Condition
Condition
chronic kidney disease (nondialyzed, dialyzed)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether dysregulation of sulfur amino acid, iron and vitamins affect thyroid function and oxidative stress/atherogenesis in patients with chronic kidney diease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
metabolism of sulfur amino acid, iron and vitamins.
thyroid function.
factors of atherogenesis.
Key secondary outcomes
samples: blood, urine, peritoneal effluent, hair.
factors of metabolism of sulfur amino acids (homocystein, cystein), iron (ferritin, hepcidin, transporters), thiocyanate (cyanide, thiosufate, sulfate), thyroid function (T3/4, fT3/4, TSH, anti-thyroglobulin antibody, lipid), inflammation/oxidative stress (CRP, cytokines, peroxidase, MDA, ROS, GSH), markers of cell damage (growth factors, CA125), atherosclerosis (chest X ray, echo, ABI, PWV), cardiovascular events (cardiovascular death, renal failure, total death, admission), others (nutritional status, vitamins, vintage of dialysis, beta2-microglobulin, hemoglobin)
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)kidney disease, require medical care
2)Followed in the outpatient of our hospital and associated clinic
3)Expected survival time is more than 6 months
4)Aged 20 to 90 years
5)Fully informed consent was obtained
Key exclusion criteria
1)Malignancy
2)Malnutrition
3)Active inflammatory or infectious disease
4)Uncontrollable diabetes mellitus
5)Abdominal ascites or pleural effusion
6)Pregnancy
7)Judged inappropriate for this study by the physicians
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Nakanishi |
Organization
Hyogo College of Medicine
Division name
Department of Internal Medicine, Division of Nephrology and Dialysis
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Japan
TEL
0798-45-6521
jin@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukiko Hasuike |
Organization
Hyogo College of Medicine
Division name
Department of Internal Medicine, Division of Nephrology and Dialysis
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Japan
TEL
0798-45-6521
Homepage URL
jin@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
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
兵庫医科大学病院
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 11 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
influence of clinical parameters on progress of atherosclerosis and cumulative survival, prospective study
Management information
Registered date
| 2007 | Year | 11 | Month | 27 | Day |
Last modified on
| 2016 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000820
| Research Plan | |
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| 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 |
