Pharmacokinetic/Pharmacodynamic Parameters of NNG-DEPO (Stimus) With Aranesp® (Amgen) in Treatment of Anemia in CKD Patients on Dialysis

PHASE1CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

September 19, 2021

Primary Completion Date

November 23, 2022

Study Completion Date

November 23, 2022

Conditions
Chronic Kidney Disease
Interventions
BIOLOGICAL

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)"

Trial Locations (1)

Unknown

NANOGEN Pharmaceutical Biotechnology JSC, Ho Chi Minh City

All Listed Sponsors
collaborator

Vietstar Biomedical Research

INDUSTRY

collaborator

Clinical Research Consultants, Inc.

INDUSTRY

collaborator

Clinical Research Viet Nam Skill Training And Consultant Company Limited

UNKNOWN

lead

Nanogen Pharmaceutical Biotechnology Joint Stock Company

INDUSTRY

NCT05636891 - Pharmacokinetic/Pharmacodynamic Parameters of NNG-DEPO (Stimus) With Aranesp® (Amgen) in Treatment of Anemia in CKD Patients on Dialysis | Biotech Hunter | Biotech Hunter