drugset / Trial / NCT05636891
Pharmacokinetic/Pharmacodynamic Parameters of NNG-DEPO (Stimus) With Aranesp® (Amgen) in Treatment of Anemia in CKD Patients on Dialysis
Phase 1
Completed
43 enrolled
Nanogen Pharmaceutical Biotechnology Joint Stock Company
Clinical Research Consultants, Inc. · collabClinical Research Viet Nam Skill Training And Consultant Company Limited · collabVietstar Biomedical Research · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a double-blind, randomized, active-control study with 2-study arms-darbepoetin alfa biosimilar and Aranesp, noninferiority trial design in dialysis patients. Dialysis patients will be randomized into 1:1 ratio to receive either Darbepoetin alfa or Aranesp 0.75 µg/kg by subcutaneous injection every other week for 24 weeks. Pharmacokinetic/pharmacodynamic parameters for evaluation are assessed as per study endpoints at defined time points on all patients. During the treatment, dose adjustments will be made as necessary to achieve a hemoglobin response, defined as maintaining Hb in target range 10 - 12 g/dL.
Timeline
- Start
- 2021-09-19
- Primary completion
- 2022-11-23
- Completion
- 2022-11-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darbepoetin alfa | Protein / enzyme biologic | 0.75 ug/kg | Subcutaneous |