drugset / Trial / NCT03029208
Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID)
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this multi-center study is to evaluate the efficacy and safety of daprodustat in subjects with anemia associated with CKD.
Timeline
- Start
- 2017-05-11
- Primary completion
- 2020-09-24
- Completion
- 2020-09-24
Publications
- Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
- Singh AK, Cizman B, Carroll K, McMurray JJV, Perkovic V, Jha V, Johansen KL, Lopes RD, Macdougall IC, Obrador GT, Waikar SS, Wanner C, Wheeler DC, Wiecek A, Stankus N, Strutz F, Blackorby A, Cobitz AR, Meadowcroft AM, Paul G, Ranganathan P, Sedani S, Solomon S. Efficacy and Safety of Daprodustat for Treatment of Anemia of Chronic Kidney Disease in Incident Dialysis Patients: A Randomized Clinical Trial. JAMA Intern Med. 2022 Jun 1;182(6):592-602. doi: 10.1001/jamainternmed.2022.0605.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daprodustat | Small molecule | 1 mg | Oral |
| Subject | Daprodustat | Small molecule | 2 mg | Oral |
| Subject | Daprodustat | Small molecule | 4 mg | Oral |
| Subject | Daprodustat | Small molecule | 6 mg | Oral |
| Subject | Daprodustat | Small molecule | 8 mg | Oral |
| Subject | Daprodustat | Small molecule | 10 mg | Oral |
| Subject | Daprodustat | Small molecule | 12 mg | Oral |
| Subject | Daprodustat | Small molecule | 16 mg | Oral |
| Subject | Daprodustat | Small molecule | 24 mg | Oral |
| Comparator | Darbepoetin alfa | Protein / enzyme biologic | 20 ug | Subcutaneous |
| Comparator | Darbepoetin alfa | Protein / enzyme biologic | 30 ug | Subcutaneous |
| Comparator | Darbepoetin alfa | Protein / enzyme biologic | 40 ug | Subcutaneous |
| Comparator | Darbepoetin alfa | Protein / enzyme biologic | 60 ug | Subcutaneous |
| Comparator | Darbepoetin alfa | Protein / enzyme biologic | 80 ug | Subcutaneous |
| Comparator | Darbepoetin alfa | Protein / enzyme biologic | 100 ug | Subcutaneous |
| Comparator | Darbepoetin alfa | Protein / enzyme biologic | 150 ug | Subcutaneous |