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

Chronic Kidney Disease Clinical Trial

Official title: 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 Active, not recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Anemia
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

• NCT number: NCT05636891
• Study type: Interventional
• Source: Nanogen Pharmaceutical Biotechnology Joint Stock Company
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: August 8, 2019
• Completion date: December 31, 2022