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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009692
Receipt No. R000011344
Scientific Title The actual situation and the effect of treatment for renal anemia on patients with chronic kidney diseases not on dialysis in regional medicine of Kyoto
Date of disclosure of the study information 2013/01/04
Last modified on 2020/07/26

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Basic information
Public title The actual situation and the effect of treatment for renal anemia on patients with chronic kidney diseases not on dialysis in regional medicine of Kyoto
Acronym Kyoto Fushimi Renal Anemia Study
Scientific Title The actual situation and the effect of treatment for renal anemia on patients with chronic kidney diseases not on dialysis in regional medicine of Kyoto
Scientific Title:Acronym Kyoto Fushimi Renal Anemia Study
Region
Japan

Condition
Condition renal anemia with chronic kidney disease not on dialysis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective is to determine the actual situation of treatment for renal anemia after long-acting erythropoiesis stimulating agents release, and to concern for the improvement of renal prognosis, cardiovascular events, and vital prognosis to achieve target hemoglobin level in regional medicine.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Composite renal outcome of chronic dialysis, kidney transplantation, and doubling time of serum creatinine level
Key secondary outcomes 1. Change of eGFR from enrollment
2. Death of any cause
3. Incidence of cardiovascular event [death of cardiovascular event, myocardial infarction, stroke, hospitalization with acute coronary syndrome, hospitalization with heart failure, history of intervention for cardiovascular events (percutaneous coronary intervention, coronary artery bypass graft, cerebrovascular treatment, intervention for artery of lower extremities, leg amputation)]
4. relation between hemoglobin level and the primary outcomes or the secondary outcomes
5. relation between type of ESA and the primary outcomes or the secondary outcomes
6. relation between type of ESA and hemoglobin level

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients with estimated glomerular filtration rate 10 and more mL/min/1.73 m2 in chronic kidney disease stage 3-5
2. Patients with hemoglobin level of <11 g/dL or receiving erythropoiesis stimulating agent
3. Outpatients at enrollment
Key exclusion criteria 1. Patients with other than renal anemia, such as gastrointestinal bleeding or hematological disorders
2. Patients who need blood transfusion frequently
3. Patients with active cancer or cancer treatment within last 2 years
4. Transplant recipients and patients who have previously received long-term dialysis
5. Patients with liver cirrhosis
6. Patients with received interferon
7. Patients with human immunodeficiency virus infection
8. Patients with pregnancy and breast-feeding
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kensei Yahata
Organization National Hospital Organization Kyoto Medical Center
Division name Department of Nephrology
Zip code
Address 1-1 Fukakusa-mukaihata cho, Fushimi-ku, Kyoto
TEL 075-641-9161
Email kyahata@kyotolan.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kensei Yahata
Organization National Hospital Organization Kyoto Medical Center
Division name Department of Nephrology
Zip code
Address 1-1 Fukakusa-mukaihata cho, Fushimi-ku, Kyoto
TEL 075-641-9161
Homepage URL
Email kyahata@kyotolan.hosp.go.jp

Sponsor
Institute National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization Kyoto Medical Center
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
2013 Year 01 Month 04 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 Main results already published
Date of protocol fixation
2013 Year 01 Month 01 Day
Date of IRB
2012 Year 07 Month 31 Day
Anticipated trial start date
2013 Year 01 Month 04 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2019 Year 07 Month 31 Day

Other
Other related information The objective is to determine the actual situation of treatment for renal anemia after long-acting erythropoiesis stimulating agents release, and to concern for the improvement of renal prognosis, cardiovascular events, and vital prognosis to achieve target hemoglobin level in regional medicine. This study is a prospective study.

Management information
Registered date
2013 Year 01 Month 04 Day
Last modified on
2020 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011344

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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