UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045872 |
|---|---|
| Receipt number | R000052369 |
| Scientific Title | Safety and Efficacy of Daprodustat in Peritoneal Dialysis Patients with Renal Anemia |
| Date of disclosure of the study information | 2021/10/26 |
| Last modified on | 2021/10/26 15:04:14 |
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Basic information
Public title
Safety and Efficacy of Daprodustat in Peritoneal Dialysis Patients with Renal Anemia
Acronym
Safety and Efficacy of Daprodustat in Peritoneal Dialysis Patients with Renal Anemia
Scientific Title
Safety and Efficacy of Daprodustat in Peritoneal Dialysis Patients with Renal Anemia
Scientific Title:Acronym
Safety and Efficacy of Daprodustat in Peritoneal Dialysis Patients with Renal Anemia
Region
| Japan |
Condition
Condition
Peritoneal dialysis patients with renal anemia
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of daprodustat in peritoneal dialysis patients with renal anemia who are receiving darbepoetin alpha.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in mean hemoglobin level from baseline to the primary efficacy evaluation period (defined as 20 to 24 weeks of treatment). The target hemoglobin level is defined as between 11.0 g/dL and 13.0 g/dL.
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
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. peritoneal dialysis patients with renal anemia who are receiving darbepoetin alpha
2. male and female, 20 years of age or older at the time of consent
3. patients on peritoneal dialysis for more than 8 weeks at the time of consent
4. patients receiving darbepoetin alpha for more than 16 weeks at the time of obtaining consent
5. Patients who have given their written consent to participate in the study.
Key exclusion criteria
1. patients with a history of hypersensitivity to any component of daprodustat
2. patients with unstable or acute heart failure
3. patients with a history of thrombosis within 6 months
4. patients with severe hypertension (systolic blood pressure of 190 mmHg or higher or diastolic blood pressure of 120 mmHg or higher)
5. patients with malignant tumors
6. Patients with severe hepatic dysfunction (Child-Pugh C)
7. Patients receiving the following drugs: clopidocrel, trimethoprem, rifampicin
8. Patients who are pregnant, lactating, may be pregnant, or plan to become pregnant.
9. patients with proliferative diabetic retinopathy, macular edema, exudative age-related macular degeneration, retinal vein occlusion, etc.
10. patients who require a substitute.
11. Other patients deemed inappropriate by the principal investigator or sub-investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yan |
Organization
Nippon Medical School
Division name
Department of Nephrology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
t-yan@nms.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yan |
Organization
Nippon Medical School
Division name
Department of Nephrology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
t-yan@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
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
Nippon Medical School Hospital Center for Clinical Research
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
clinicaltrial@nms.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
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2023 | 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 | 26 | Day |
Last modified on
| 2021 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052369
