Dec. 26, 2022 |
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Jan. 06, 2023 |
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jRCT2041220113 |
An Integrated Pharmacokinetic and Safety Open-label Basket Trial of Daprodustat for the Treatment of Anemia Associated with Chronic Kidney Disease in Male and Female Children and Adolescents Aged 3 Months to Under 18 Years Requiring or Not Requiring Dialysis (ASCEND-P) |
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Anemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat -Pediatric (ASCEND-P) (ASCEND-P) |
Takeuchi Rika |
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Syneos Health Clinical K.K. |
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10F Umeda Daibiru, 3-3-10 Umeda, Kita-ku, Osaka |
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+81-70-1415-7743 |
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rika.takeuchi@syneoshealth.com |
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Takeuchi Rika |
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Syneos Health Clinical K.K. |
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10F Umeda Daibiru, 3-3-10 Umeda, Kita-ku, Osaka |
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+81-70-1415-7743 |
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rika.takeuchi@syneoshealth.com |
Pending |
Feb. 03, 2023 |
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18 | ||
Interventional |
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single arm study |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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treatment purpose |
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Inclusion criteria: |
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Exclusion Criteria: |
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3month old over | ||
18age old not | ||
Both |
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Renal anemia |
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All participants will receive oral daprodustat for a total of 52 weeks and will be followed for an additional 4 weeks after completing treatment. The lowest dose level defined (0.125 mg once daily [QD]) will be achieved by dosing 0.25 mg three times a week (TIW). All other dose steps involve QD dosing frequency. |
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Describe the safety of daprodustat, overall (all ages) and in each age group. |
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GlaxoSmithKline Research and Development Limited |
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital IRB | |
2-9 Myoken-cho, Showa-ku, Nagoya-shi, Aichi, Aichi | |
Approval | |
Nanbu Medical Center & Children's Medical Center IRB | |
118-1 Arakawa, Aza, Haebaru-cho, Shimajiri-gun, Okinawa, Aichi | |
Approval | |
No |
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2021-002013-34 | |
EudraCT |
US/Argentina/ Australia/Belgium/France/Germany/Italy/Netherlands/Russia/Spain/South Korea/Poland/Turkey/Canada/UK |