UMIN-CTR Clinical Trial

Basic information
Public title	Study of effectiveness and safety of roxadustat for renal anemia in dialysis patients
Acronym	roxadustat study
Scientific Title	Study of effectiveness and safety of roxadustat for renal anemia in dialysis patients
Scientific Title:Acronym	roxadustat study
Region	Japan

Condition
Condition	Renal anemia in dialysis patients
Classification by specialty	Nephrology Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness and safety of roxadustat for renal anemia in dialysis patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hb(evaluated before administration and 4, 12, and 24 weeks after administration)
Key secondary outcomes	Blood test(MCV,MCH,MCHC,reticulocyte count,erythropoietin,serum iron,ferritin,TIBC and TSAT),blood pressure,activity(frail checklist prepared by the Ministry of Health, Labor and Welfare)and digestive symptoms(Gastrointestinal Symptom Rating Scale). All evaluated before administration and 4, 12, and 24 weeks after administration.

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Any of our maintenance hemodialysis patients with no improvement in anemia after existing treatment for various causes and serum ferritin >= 300 ng/ml, epoetin kappa dose >= 9000 international units/week, darbepoetin alpha dose >= 40 micrograms/week, or epoetin beta pegol dose >=150 micrograms/four weeks.
Key exclusion criteria	Patient with thromboembolism within 6 months after treatment, malignant tumor during treatment, eye disease during treatment, and moderate or higher liver dysfunction.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Junki Middle name Last name Aikawa
Organization	Nagakubo Hospital
Division name	Dr
Zip code	186-0011
Address	6907-1 Yaho Kunitachi Tokyo, 186-0011, Japan
TEL	042-571-2211
Email	shiki12070712@gmail.com

Public contact
Name of contact person	1st name Junki Middle name Last name Aikawa
Organization	Nagakubo Hospital
Division name	Dr
Zip code	186-0011
Address	6907-1 Yaho Kunitachi Tokyo, 186-0011, Japan
TEL	042-571-2211
Homepage URL
Email	shiki12070712@gmail.com

Sponsor
Institute	Nagakubo Hospital
Institute
Department

Funding Source
Organization	nothing
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagakubo Hospital
Address	6907-1 Yaho Kunitachi Tokyo, 186-0011, Japan
Tel	042-571-2211
Email	nagakubohospital1f@yahoo.co.jp

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	2020 Year 02 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	8
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	2020 Year 01 Month 01 Day
Date of IRB	2019 Year 12 Month 16 Day
Anticipated trial start date	2020 Year 01 Month 01 Day
Last follow-up date	2022 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	nothing paticular

Management information
Registered date	2020 Year 01 Month 22 Day
Last modified on	2021 Year 07 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044650