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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011949
Receipt No. 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

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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
Email 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
Email cherry39@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013421

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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