UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004136 |
|---|---|
| Receipt number | R000004960 |
| Scientific Title | An influence of Treatment of Renal Anemia on Iron Dysregulation in patients with chronic kidney disease |
| Date of disclosure of the study information | 2010/09/01 |
| Last modified on | 2015/10/02 17:02:01 |
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Basic information
Public title
An influence of Treatment of Renal Anemia on Iron Dysregulation in patients with chronic kidney disease
Acronym
TRAID study
Scientific Title
An influence of Treatment of Renal Anemia on Iron Dysregulation in patients with chronic kidney disease
Scientific Title:Acronym
TRAID study
Region
| Japan |
Condition
Condition
chronic kidney disease (CKD)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of treatment of renal anemia on iron dysregulation, inflammation, oxidative stress, and MBD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anemia: RBC,Hb,Ht,reticulocytes etc.
Iron metabolism: serum iron, TIBC, Tsat, ferritin,hepcidin,aminolevulinic acid,iron transporters etc.
Key secondary outcomes
inflammation and oxidative stress: high-sensitivity-CRP,pentraxin,inflammatory cytokines (IL-6,TNF-alpha), malondialdehyde,8-OHdG etc. MBD: metabolism of Ca and P (PTH,FGF23,fetuinA),markers of bone metabolism (BMD etc.),markers of vasculopathy (pulse wave velocity etc.)
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
EPO is changed to darbepoietin as treatment of renal anemia
Interventions/Control_2
darbepoietin as treatment of renal anemia
Interventions/Control_3
no intervention
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
hemodialysis patients with Hb <10 g/dl, serum feritin >200ng/ml
Key exclusion criteria
malignant disease, blood disease, severe infection
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Nakanishi |
Organization
Hyogo College of Medicine
Division name
Division fo Kidney and Dialysis, Department of Internal Medicine
Zip code
Address
1-1 Mukogawa-cho Nishinomiya
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
Division fo Kidney and Dialysis, Department of Internal Medicine
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya
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
No source
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
| 2010 | Year | 09 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 31 | Day |
Last modified on
| 2015 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004960
