UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011949 |
|---|---|
| Receipt number | R000013421 |
| Scientific Title | Dysregulation of iron and renal anemia treatment in patients with chronic kidney disease |
| Date of disclosure of the study information | 2013/10/03 |
| Last modified on | 2015/06/25 15:02:07 |
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Basic information
Public title
Dysregulation of iron and renal anemia treatment in patients with chronic kidney disease
Acronym
DIRAT-2 study
Scientific Title
Dysregulation of iron and renal anemia treatment in patients with chronic kidney disease
Scientific Title:Acronym
DIRAT-2 study
Region
| Japan |
Condition
Condition
Patients with chronic kidney disease
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Influence of renal anemia treatment on oxidative stress
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Factors related to iron regulation: serum iron, transferrin saturation rate, ferritin, frataxin et al.
Factors related to oxidative stress: malondialdehyde, 8OHdG, AOPP, pentosidine, GSH et al.
Key secondary outcomes
Factors related to inflammation: high-sensitivity CRP, interleukin-6, tumor necrosis factors-alpha, pentraxin, troponin T, et al.
Factors related to nutrition: BMI, albumin, prealbumin et al.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral iron supplementation are used in priority to intravenous adminisitration as renal anemia treatment
Interventions/Control_2
Intravenous iron administration are used as renal anemia 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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Chronic kidney disease patients who are administared erythropoiesis stimulating agents (ESA)
Key exclusion criteria
malignancy and inflammatory, gastro-intestinal, hepatic, and bone marrow diseases
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Nakanishi |
Organization
Hyogo College of Medicine
Division name
Dep Internal Medicine, Div Kidney and Dialysis
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798456521
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
Dep Internal Medicine, Div Kidney and Dialysis
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798456521
Homepage URL
cherry39@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
Tanaka-Kitanoda Hospital, Hojo-Tanaka Hospital,Yashiro-Tanaka Clinic
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（兵庫県），田仲北野田病院（大阪府），北条田仲病院（兵庫県），社田仲クリニック（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 03 | Day |
Last modified on
| 2015 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013421
