A Study to Compare Efficacy and Safety of Nanogen's Darbepoetin Alfa With Aranesp® (Amgen) in the Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis (CKD) — CKD  

Anemia Clinical Trial

Official title: A Multicenter, Double-blind, Randomized, Parallel Comparative Study of Efficacy and Safety of Nanogen's Darbepoetin Alfa With Aranesp® (Amgen) in the Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis

Status Active, not recruiting

Clinical Trial Summary

This is a double-blind, two-arm, randomized, multicenter to compare the efficacy and safety of NNG-DEPO and Aranesp in CKD on dialysis patients.

Patients aged 18 to 65 years (inclusive), diagnosed with anemia due to CKD in dialysis, who meet all inclusion criteria, requiring treatment with Darbepoetin alfa. The study subjects (patients) will be randomized into a 1:1 ratio to NNG-DEPO and Aranesp treatment arms respectively. Patients will receive either NNG-DEPO or Aranesp 0.75 µg/kg by subcutaneous injection every other week for 24 weeks.

During the treatment, dose adjustments will be made as necessary to achieve a hemoglobin response, defined as maintaining Hb in the target range of 10 - 12 g/dL.

Clinical Trial Description

The phase of the study: phase 3

Study sites:

Nguyen Tri Phuong Hospital Thu Duc City Hospital An Sinh Hospital Thong Nhat General Hospital Dong Nai

Sample size: 214 patients

TARGET POPULATION: Patients with chronic kidney disease undergoing dialysis (aged 18 to 65 years)

STUDY GROUPS:

Darbepoetin alfa (Nanogen) SC/IV route 0.75 µg/kg Q2W, for 24 weeks. Aranesp® (Amgen) SC/IV route 0.75 µg/kg Q2W, for 24 weeks.

Blood sample will be taken for Complete Blood Count (CBC) test at each visit (Week 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24) to monitor haemoglobin response.

Study Procedures:

This study was designed for 26 weeks (2 weeks for screening and 24 weeks for treatment) and there are total of 14 visits:

Visit 1 is the screening visit. Visit 2: Randomization, initiate study treatment, assess the Hb baseline. Visit 3 - 7 is to monitor, evaluate the efficacy, safety. Visit 8 is to interim assess the efficacy, safety for each patient to make the decision continous/discontinous the study treatment.

Vist 9 -13 is to monitor, evaluate the efficacy, safety. Visit 14 is termination visit.

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 darbepoetin alfa anti-bodies (immunogenicity). ;

Related Conditions & MeSH terms

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

• NCT number: NCT05585645
• Study type: Interventional
• Source: Nanogen Pharmaceutical Biotechnology Joint Stock Company
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 8, 2019
• Completion date: December 31, 2022