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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019283
Receipt No. R000022296
Scientific Title Low dose iron supplementation and efficacy of erythropoiesis in renal anemia treatment for hemodialysis patients: a randomized controlled study
Date of disclosure of the study information 2015/10/08
Last modified on 2018/04/10

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Basic information
Public title Low dose iron supplementation and efficacy of erythropoiesis in renal anemia treatment for hemodialysis patients: a randomized controlled study
Acronym Low dose iron supplementation and efficacy of erythropoiesis induced by epoetin beta pegol
Scientific Title Low dose iron supplementation and efficacy of erythropoiesis in renal anemia treatment for hemodialysis patients: a randomized controlled study
Scientific Title:Acronym Low dose iron supplementation and efficacy of erythropoiesis induced by epoetin beta pegol
Region
Japan

Condition
Condition Renal anemia
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of epoetin beta pegol efficacy between low dose iron and routine iron supplementations.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1) Hemoglobin and erythropoiesis-related indexes
(2)Blood chemical examination including iron-related, inflammation, nutrition indexes
(3)Required dose of epoetin beta pegol
(4)Hemodynamic parameters

(After 3 months of iron supplementation)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 Low dose iron supplementation (Fesin 6A/ 3months)
Interventions/Control_2 Routine iron supplementation (Fesin 12A/ 3months)
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients with maintenance hemodialysis
(2) Patients with renal anemia, who are treated with rHuEPO and iron
Key exclusion criteria (1) Patients with chronic inflammation, malignant disorder, severe congestive heart failure, respiratory organs, and liver disorder
(2) Patients who are receiving dialysis modalities other than hemodialysis
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoyuki Kawano
Organization Bunko Jin Clinic
Division name Director /Director of hemodialysis clinic
Zip code
Address 35 Yatsuchou, Kanazawa-ku, Yokohama city, Japan
TEL 045-790-8280
Email t-kawano@kousai.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyuki Kawano
Organization Bunko Jin Clinic
Division name Director /Director of hemodialysis clinic
Zip code
Address 35 Yatsuchou, Kanazawa-ku, Yokohama city, Japan
TEL 045-790-8280
Homepage URL
Email t-kawano@kousai.or.jp

Sponsor
Institute Bunko Jin Clinic
Institute
Department

Funding Source
Organization Kousai-kai medical corporation, Bunko Jin Clinic
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 厚済会透析クリニック(神奈川県)

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 08 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 Completed
Date of protocol fixation
2015 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 10 Month 08 Day
Last modified on
2018 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022296

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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