NCT05636891

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

Randomized, Double-blind, Parallel, Active Controlled Study to Compare Pharmacokinetic/Pharmacodynamic Parameters of Nanogen's Darbepoetin Alfa With Aranesp® (Amgen) in Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Nanogen Pharmaceutical Biotechnology Joint Stock Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PHASE OF TRIAL: I SAMPLE SIZE: 43 for pharmacokinetic/pharmacodynamic parameters TARGET POPULATION: Patients with chronic kidney disease undergoing dialysis STUDY GROUPS: 1. Darbepoetin alfa (Nanogen) SC 0.75 µg/kg Q2W, for 24 weeks. 2. Aranesp® (Amgen) SC 0.75 µg/kg Q2W, for 24 weeks. PK ASSESSMENT: Blood samples for PK assessments will be collected at: * IV: time zero (predose) before injection of study drug and then after 0.25, 0.5, 4, 12, 24, 48, 96, 144, 240 and 336 hours post-dose. * SC: time zero (predose) before injection of study drug and then after 4, 12, 24, 48, 96, 144, 240 and 336 hours post-dose. PD ASSESSMENT: Blood samples for PD assessments will be collected at time zero (predose) before injection of study drug and then after 24, 48, 96, 144, 240 and 336 hours post-dose. SAFETY AND TOLERABILITY ASSESSMENT: Safety and tolerability assessments will be performed at each visit. Following variables will be considered to define the safety and tolerability of investigational drugs: * Clinical adverse events (AEs): frequency of AEs, overall and by intensity. * Severe clinical adverse events (SAEs): frequency of AEs, overall and by intensity. * Symptoms directed physical examination including body weight, and vital signs during treatment period: mean change from baseline and the frequency of clinically relevant changes from baseline. * Laboratory tests: frequency of clinically relevant changes from baseline. * The frequency of any concomitant medication administered to treat any adverse events. * Presence of anti-bodies to darbepoetin alfa (immunogenicity).

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2021-09-19
• Primary completion: 2022-11-23
• Completion: 2022-11-23
• First posted: 2022-12-05
• Last updated: 2025-03-30

Locations

1 site across 1 country: Vietnam