UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045857 |
|---|---|
| Receipt number | R000050339 |
| Scientific Title | Effect of roxadustat on erythropoiesis and iron metabolism |
| Date of disclosure of the study information | 2021/10/26 |
| Last modified on | 2023/09/11 09:37:57 |
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Basic information
Public title
Effect of roxadustat on erythropoiesis and iron metabolism
Acronym
Effect of roxadustat
Scientific Title
Effect of roxadustat on erythropoiesis and iron metabolism
Scientific Title:Acronym
Effect of roxadustat on erythropoiesis and iron metabolism
Region
| Japan |
Condition
Condition
renal anemia
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of differences between roxadustst and ESA on erythropoiesis and iron metabolism
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
comparison between changes in hemoglobin by ESA treatment and those after switching from ESA to roxadustat
Key secondary outcomes
comparison between changes in biomarkers of iron metabolism by ESA treatment and those after switching from ESA to roxadustat
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
roxadustst 70mg or 100mg
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) PD patients who are treated at Showa university and HD patients who are treated at Shibagaki clinic.
2) Hemoglobin level above 9g/dL, and ferritin 100 ng/mL or TSAT>20%.
3) Patienta who are more than 20 year-old
4) Patients who are treated by ESA more than 3 months.
5) Patients who are provided written, informed consent to participate
Key exclusion criteria
1) Patients who have history of allergy for HIF-PH inhibitor.
2) Patients who are taking HIF-PH inhibitor.
3) Patients whose serum ferritin level 100 ng/mL and TSAT<20%.
4) Pregnant women.
5) Patients with bleeding, severe liver disease, malignant, chronic infection, autoimmune disease, polycystic kidney disease, active diabetic retinopathy.
6) Patients who are ineligible for participating the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Honda |
Organization
Showa University
Division name
Department of Medicine, Division of Nephrology, School of Medicine
Zip code
142-8666
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8533
hondah@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Honda |
Organization
Showa University
Division name
Department of Medicine, Division of Nephrology, School of Medicine
Zip code
142-8666
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8533
Homepage URL
hondah@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Showa University
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
Showa University Committee on Human Research
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8000
hondah@med.showa-u.ac.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
| 2021 | Year | 10 | Month | 26 | 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
34
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
| 2021 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 25 | Day |
Last modified on
| 2023 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050339
