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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000386
Receipt No. R000000479
Scientific Title Open label multi-center randomized parallel two-group comparison test of the effects of hemoglobin levels on cardiovascular complications, prognosis, and quality of life in chronic hemodialysis patients
Date of disclosure of the study information 2006/04/01
Last modified on 2009/09/30

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Basic information
Public title Open label multi-center randomized parallel two-group comparison test of the effects of hemoglobin levels on cardiovascular complications, prognosis, and quality of life in chronic hemodialysis patients
Acronym Multi-center randomized clinical studies of the effects of hemoglobin levels on cardiovascular complications in hemodialysis patients
Scientific Title Open label multi-center randomized parallel two-group comparison test of the effects of hemoglobin levels on cardiovascular complications, prognosis, and quality of life in chronic hemodialysis patients
Scientific Title:Acronym Multi-center randomized clinical studies of the effects of hemoglobin levels on cardiovascular complications in hemodialysis patients
Region
Japan

Condition
Condition Patients on hemodialysis therapy due to end-stage renal failure
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to determine whether hemoglobin levels in the patients on hemodialysis may affect the prevalence of cardiovascular complication, quality of life, residual renal function, and shunt failure.
Basic objectives2 Others
Basic objectives -Others To examine the efficacy of the treatment
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1) Patient death by any cause including accidental death and every kind of complications.
2) Newly diagnosed ischemic heart diseases: acute myocardial infarction, coronary heart disease diagnosed by coronary arteriography, percutaneous coronary intervention, coronary artery bypass grafting
3) Shunt failure: any procedures for reconstruction of A-V fistula due to decreased blood flow.
4) Newly diagnosed cereberovascular diseases: cerebral hemorrhage/infarction, subarachnoid hemorrhage
5) Newly diagnosed peripheral vessel disorders: intermittent claudication with definitive peripheral vascular disorders, newly developed ulcer or gangrene of extremities, delayed wound healing.
Key secondary outcomes 1) Changes in sf36 scores
2) Changes in urine volume
3) Changes in left ventricular mass index measured by echocardiography
4) Changes in pulse wave velocity
5) Hospitalization due to any diseases including hospitalization for clinical evaluation of the newly developed diseases

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Adjust doses of iron erythropoietin to maintain hemoglobin level between 9.0 to 10.5 g/dl
Interventions/Control_2 Adjust doses of iron and erythropoietin to maintain hemoglobin level between 11.0 to 12.0 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
21 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Male and female patients; age between 21 years old and 80 years old.
Written informed consent must be obtained. Patients should be on hemodialysis for longer than 3 months and in stable medical condition.
Key exclusion criteria 1) Uncontrollable severe hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg) even with appropriate antihypertensive agents
2) Cardiovascular complication or shunt failure within 3 months
3) Malignant diseases
4) Patients contraindicated to erythropoietin or iron
5) Any patients who are considered to be inappropriate by physician
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Matsuhiko Hayashi
Organization Keio University School of Medicine
Division name Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3878
Email

Public contact
Name of contact person
1st name
Middle name
Last name Matsuhiko Hayashi
Organization Keio University School of Medicine
Division name Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3878
Homepage URL
Email matuhiko@sc.itc.keio.ac.jp

Sponsor
Institute Study group for appropriate hemoglobin level
Institute
Department

Funding Source
Organization self-funding
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 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 Completed
Date of protocol fixation
2006 Year 03 Month 08 Day
Date of IRB
Anticipated trial start date
2006 Year 07 Month 01 Day
Last follow-up date
2009 Year 01 Month 01 Day
Date of closure to data entry
2009 Year 12 Month 01 Day
Date trial data considered complete
2010 Year 06 Month 01 Day
Date analysis concluded
2010 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 03 Month 31 Day
Last modified on
2009 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000479

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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