UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010762 |
|---|---|
| Receipt number | R000012554 |
| Scientific Title | Effects of erythropoiesis stimulating agentin on heart failure patients with reduced left ventricular function and the cardiorenal anemia syndrome |
| Date of disclosure of the study information | 2013/05/20 |
| Last modified on | 2016/02/10 16:49:44 |
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Basic information
Public title
Effects of erythropoiesis stimulating agentin on heart failure patients with reduced left ventricular function and the cardiorenal anemia syndrome
Acronym
Effects of erythropoiesis stimulating agent on heart failure patients
Scientific Title
Effects of erythropoiesis stimulating agentin on heart failure patients with reduced left ventricular function and the cardiorenal anemia syndrome
Scientific Title:Acronym
Effects of erythropoiesis stimulating agent on heart failure patients
Region
| Japan |
Condition
Condition
Chronic heart failure patients with reduced left ventricular function
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the effect of erythropoiesis stimulating agent on chronic heart failure patients with the cardiorenal anemia syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sudden cardiac death, death and hospitalization due to worsening heart failure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
with anemia
Interventions/Control_2
without anemia
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Hb<12g/dl and eGFR<60ml/min/1.73m2 for atleast 3 months
2. Optimal pharmacologic therapy including ACEI, ARB and beta-blockers
3. TSAT>15.0%, Vit B12, folate concentration in the normal range
Key exclusion criteria
1. uncontrolled hypertension (>160/100 mmHg)
2. previous history of cardiovascular disease within 3 months
3. new-onset of atrial fibrillation and atrial flutter within one month
4. Cr>3mg/dl
5. renal transplantation within 6 months, or chemo and radiation therapy within 12 months. Previous history of malignant disease, hematological disorder.
6. allergy of ESA
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidekazu Tanaka |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kobe University Graduate School of Medicine |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
Address
TEL
Homepage URL
tanakah@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2013 | Year | 05 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | 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
| 2013 | Year | 05 | Month | 20 | Day |
Last modified on
| 2016 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012554
