UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000386 |
|---|---|
| Receipt number | 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 09:10:24 |
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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
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
matuhiko@sc.itc.keio.ac.jp
Sponsor or person
Institute
Study group for appropriate hemoglobin level
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000479
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