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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000316
Receipt No. R000000402
Scientific Title An open, randomized, parallel group, multi-center study on the effect of a resume of Renal Anemia Treatment by Erythropoietin supplemented with Iron and vitamin C on the Prognosis in Hemodialysis Patients
Date of disclosure of the study information 2006/04/12
Last modified on 2016/08/20

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Basic information
Public title An open, randomized, parallel group, multi-center study on the effect of a resume of Renal Anemia Treatment by Erythropoietin supplemented with Iron and vitamin C on the Prognosis in Hemodialysis Patients
Acronym ACTIVE
Scientific Title An open, randomized, parallel group, multi-center study on the effect of a resume of Renal Anemia Treatment by Erythropoietin supplemented with Iron and vitamin C on the Prognosis in Hemodialysis Patients
Scientific Title:Acronym ACTIVE
Region
Japan

Condition
Condition Renal anemia in maintenance dialysis patients
Classification by specialty
Nephrology Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The object of the present study is the comparison of treatments for renal anemia in maintenance dialysis patients between the conventional therapy and the newly proposed protocolized therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1) required doses of erythropoietin and iron for maintaining Hb level>11 g/dl
2) nutritional state 3) cardiovascular event, 4) hospitaization, 5)survival rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
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 Protocolized treatment for renal anemia that was proposed by ACTIVE study group.
Doses of erythropoietin, iron and vitamin C were changed every month by serum ferritin level and Hb concentration according to ACTIVE protocol.
Interventions/Control_2 Conventional therapy for renal anemia;
Attending physician determined the doses of erythropoietin and iron.
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

Not applicable
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Patients with renal anemia receiving erythropoietin who have maintained dialysis therapy for over 1 year.
Key exclusion criteria 1) Patients with malignancy, infection and severe liver and lung diseases, 2)Patients receiving steroids and immunosuppressants
Target sample size 450

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Kuragano
Organization Hyogo College of Medicine
Division name Department of kidney and dislysis
Zip code
Address 1-1 Mukogawa-cho Nishinomiya
TEL 0798-45-6521
Email kuragano@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Kuragano
Organization ACTIVE study office
Division name Department of kidney and dialysis
Zip code
Address 1-1 Mukogawa-cho Nishinomiya
TEL 0798-45-6521
Homepage URL
Email kuragano@hyo-med.ac.jp

Sponsor
Institute Department of Kidney and Dialysis, Hyogo College of Medicine
Institute
Department

Funding Source
Organization Department account fund
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

Other administrative information
Date of disclosure of the study information
2006 Year 04 Month 12 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
2005 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2006 Year 02 Month 01 Day
Last follow-up date
2010 Year 02 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
2006 Year 01 Month 31 Day
Last modified on
2016 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000402

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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