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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)

NCT05585645 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2025-03-27

No results posted yet for this study

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.

Conditions

  • Anemia
  • Chronic Kidney Disease Requiring Chronic Dialysis

Interventions

BIOLOGICAL

Stimus (NNG-DEPO)

Nanogen's Darbepoetin alfa 10µg/0.4mL, 20µg/0.5mL, 40µg/0.4mL, 60µg/0.3mL, prefilled syringe

Sponsors & Collaborators

  • Vietstar Biomedical Research

    collaborator INDUSTRY

  • MEDPHASE CLINICAL RESEARCH CONSULTANT COMPANY LIMITED

    collaborator UNKNOWN

  • CLINICAL RESEARCH VIET NAM SKILL TRAINING AND CONSULTING COMPANY LIMITED

    collaborator UNKNOWN

  • MedProve Inc

    collaborator UNKNOWN

  • Nanogen Pharmaceutical Biotechnology Joint Stock Company

    lead INDUSTRY

Principal Investigators

  • Bui V Pham, MD. PhD · Nguyen Tri Phuong Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-08
Primary Completion
2022-11-23
Completion
2022-11-23

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05585645 on ClinicalTrials.gov