UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001121 |
|---|---|
| Receipt number | R000001360 |
| Scientific Title | Metabolism of Iron and Erythropoiesis-stimulating agents (ESA) in chronic kidney disease (CKD) |
| Date of disclosure of the study information | 2008/04/22 |
| Last modified on | 2015/10/02 16:18:26 |
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Basic information
Public title
Metabolism of Iron and Erythropoiesis-stimulating agents (ESA) in chronic kidney disease (CKD)
Acronym
MIE study
Scientific Title
Metabolism of Iron and Erythropoiesis-stimulating agents (ESA) in chronic kidney disease (CKD)
Scientific Title:Acronym
MIE study
Region
| Japan |
Condition
Condition
CKD (non-dialysis, dialysis)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether ESA administration affect dysregulation of iron, oxidative stress/atherogenesis in patients with CKD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
metabolism of iron, oxidative stress, and factors of atherogenesis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment with long-acting ESA; dose of ESA and iron were changed by Hb concentration (target 10-11 g/dl).
Interventions/Control_2
Treatment with traditional ESA; dose of ESA and iron were changed by Hb concentration (target 10-11 g/dl).
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)Inappropriate for this study judged by the physicians
Target sample size
40
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
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 04 | Month | 22 | 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
| 2008 | Year | 04 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 04 | Month | 17 | 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=R000001360
