43
Participants
Start Date
September 19, 2021
Primary Completion Date
November 23, 2022
Study Completion Date
November 23, 2022
Stimus
"* NNG-DEPO (Darbepoetin alfa 10 mcg/0.4 mL, 20 mcg/0.5 mL, 40 mcg/0.4 mL, 60 mcg/0.3 mL) is available as a prefilled syringe in a sterile, colorless, glass tube.~* Aranesp® (Darbepoetin alfa 10 mcg/ 0.4 mL, 20 mcg/ 0.5 mL, 40 mcg/ 0.4 mL, 60 mcg/ 0.3 mL) is manufactured by Amgen, as a pre-filled syringe in a sterile, glass tube, colourless.~Storage: 2-8ºC, not frozen. The process of transporting and storing the drug must ensure the temperature in the range of 2-8ºC.~NNG-DEPO/Aranesp is administered subcutaneously (or intravenously for patients with PK-PD in the previous IV group), at a dose of 0.75 g/kg initially, every 2 weeks at the second visit.~IPs will be prepared according to standard procedure (SOP). Dosage adjustment guideline:~Patients will have hemoglobin levels monitored every 2 weeks. The investigators will evaluate and adjust the dose of Darbepoetin alfa to maintain the Hb levels within the target range (10 - 12 g/dL)"
NANOGEN Pharmaceutical Biotechnology JSC, Ho Chi Minh City
Vietstar Biomedical Research
INDUSTRY
Clinical Research Consultants, Inc.
INDUSTRY
Clinical Research Viet Nam Skill Training And Consultant Company Limited
UNKNOWN
Nanogen Pharmaceutical Biotechnology Joint Stock Company
INDUSTRY