UMIN-CTR Clinical Trial

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