UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041546 |
|---|---|
| Receipt number | R000047433 |
| Scientific Title | Effect of daprodustat on renal anemia in patients with chronic kidney disease |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2023/01/20 16:11:32 |
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Basic information
Public title
Effect of daprodustat on renal anemia in patients with chronic kidney disease
Acronym
Effect of daprodustat on renal anemia
Scientific Title
Effect of daprodustat on renal anemia in patients with chronic kidney disease
Scientific Title:Acronym
Effect of daprodustat on renal anemia
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of daprodustat on renal anemia in patients with chronic kidney disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemoglobin concentration, serum iron, transferrin saturation, serum ferritin, hepcidin
Key secondary outcomes
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
Daprodustat tablets are orally administered once daily. The dose of daprodustat tablet is appropriately increased or decreased depending on the blood hemoglobin concentration.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Chronic kidney disease patients with renal anemia
Key exclusion criteria
Patients complicated with serious diseases such as malignancy, heart failure (NYHA III degrees or more), and liver cirrhosis
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Michio |
| Middle name | |
| Last name | Kuwahara |
Organization
Saitama Tsukinomori Clinic
Division name
Division of Nephrology
Zip code
339-0012
Address
366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
TEL
0487921811
kuwahara@k-naika-cl.jp
Public contact
Name of contact person
| 1st name | Michio |
| Middle name | |
| Last name | Kuwahara |
Organization
Saitama Tsukinomori Clinic
Division name
Division of Nephrology
Zip code
339-0012
Address
366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
TEL
0487921811
Homepage URL
kuwahara@k-naika-cl.jp
Sponsor or person
Institute
Saitama Tsukinomori Clinic
Institute
Department
Personal name
Funding Source
Organization
Saitama Tsukinomori Clinic
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
The Ethics Committee of Saitama Tsukinomori Clinic
Address
366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
Tel
0487921811
hayama@k-naika-cl.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 | 09 | 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
10
Results
The median dose of darbepoetin before switching was 40 micrograms/wk, and all subjects received daprodustat 4 mg orally once daily at the time of switching. After that, the dose of daprodustat was adjusted appropriately to achieve the guideline target Hb of 10-12g/dL. Hb was 10.9 + 0.4(SE)g/dL when switched to daprodustat. Hb levels did not change significantly until 12 months and were maintained at 10-12g/dL.
Results date posted
| 2023 | Year | 01 | Month | 20 | Day |
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 | 08 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 15 | Day |
Other
Other related information
We evaluated the efficacy and safety of switching from darbepoetin to daprodustat over a 12-month period in 10 hemodialysis patients receiving darbepoetin for renal anemia. The age of the 10 included patients was 74.3 + 2.4 (SE) years, and the duration of dialysis was 4.1 + 1.0 (SE) years. The median dose of darbepoetin before switching was 40 micrograms/wk, and all subjects received daprodustat 4 mg orally once daily at the time of switching. After that, the dose of daprodustat was adjusted appropriately to achieve the guideline target Hb of 10-12g/dL. The median dose of daprodustat was 6 mg one month after the start of administration and remained unchanged thereafter. Hb was 10.9 + 0.4(SE)g/dL when switched to daprodustat. Hb levels did not change significantly until 12 months and were maintained at 10-12g/dL. No side effects of roxadustat were observed in all patients. The results of this study were presented at the Saitama Durblock Tablets Web Seminar (Saitama, May 2021 and Saitama, December 2022).
Management information
Registered date
| 2020 | Year | 08 | Month | 25 | Day |
Last modified on
| 2023 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047433
