UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004136
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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 Division fo Kidney and Dialysis, Department of Internal Medicine
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya
TEL 0798-45-6521
Homepage URL
Email jin@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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004960

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.