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 | Completed Phase 3

• 1 other identifier: NNG06.2
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

CKD on dialysis; Nanogen; Anemia; Darbepoetin Alfa

Outcome Measures

Primary Outcomes (1)

• The mean change Hemoglobin level from baseline to Week 24

  Week 0 (Assessed predose)- Week 24

Secondary Outcomes (7)

• Proportion of patients achieving 1 g/dL rise in Hb from baseline during 24 weeks after treatment

  Week 0 (Assessed predose)- Week 24

• Proportion of patients achieving Hb within the target range (10 - 12 g/dL) at week 24.

  Week 24

• Proportion of patients need for blood transfusion during 24 weeks after treatment.

  Week 0 (Assessed predose)- Week 24

• 4. The mean dose of NNG-DEPO/Aranesp administered for achievement of Hb in the target Hb levels (10 - 12 g/dL) during 24 weeks.

  Week 0 (Assessed predose)- Week 24

• Time to initial achievement of Hb ≥ 11 g/dL.

  Week 0 (Assessed predose)- Week 24

Study Arms (2)

Stimus

EXPERIMENTAL

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. 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) at a dose of 0.75 g/kg initially, every 2 weeks at the second visit. Study drug 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)

Biological: Stimus (NNG-DEPO)

Aranesp

ACTIVE COMPARATOR

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) at a dose of 0.75 g/kg initially, every 2 weeks at the second visit. Study drug 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)

Biological: Stimus (NNG-DEPO)

Interventions

Stimus (NNG-DEPO) BIOLOGICAL

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

Aranesp; Stimus

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients signed the informe consent form and adhere to study visit schedule.
• Male or female patients aged from 18 to 65 years.
• Patients on hemodialysis or peritoneal dialysis for at least 3 months and have Hb baseline \<10 g/dL during the screening period.
• Have transferrin saturation ≥ 20%, serum ferritin ≥ 200 ng/mL, vitamin B12 and folate within the normal range.
• Have expected survival of at least 6 months from time of enrollment (by investigator's assessment).
• Women childbearing age must agree to use medically acceptable methods of contraception during the study and for 6 months after the last study treatment.
• The patient does not have any serious medical conditions that may affect to study treatment compliance.

You may not qualify if:

• Uncontrolled hypertension over 2 weeks prior to and within the screening period (BP ≥ 160/90 mmHg).
• Patients treated with Darbepoetin alfa or r-HuEPO within 4 weeks prior to enrollment.
• Patients with Uncontrolled diabetes mellitus with HbA1C ≥ 10%.
• Congestive Heart Failure of grade 3 or 4 as New York Heart Association classification.
• History of unstable angina or myocardial infarction within 6 months.
• History of Grand mal seizures in last 2 years.
• Present with severe hyperparathyroidism (iPTH \>1500 pg/mL for Dialysis).
• History of major surgery within 12 weeks prior to screening.
• Systemic hematologic disorders including sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma and hemolytic anemia.
• Systemic infections, active inflammatory diseases and malignancies.
• Active liver disease or hepatic with liver enzymes AST and ALT raised \> 2-times of laboratory normal values, child B or child C cirrhosis.
• Are being treated with androgen therapy within the 8 weeks prior to the screening period.
• Pregnant or suspected pregnant women, breast-feeding women.
• Patients scheduled for any transplant procedure within 6 months of screening or with a previous history of kidney transplantation.
• Patients who are hypersensitive to any of substances of investigational product.

Sponsors & Collaborators

• Nanogen Pharmaceutical Biotechnology Joint Stock Company: lead
• Vietstar Biomedical Research: collaborator
• MEDPHASE CLINICAL RESEARCH CONSULTANT COMPANY LIMITED: collaborator
• CLINICAL RESEARCH VIET NAM SKILL TRAINING AND CONSULTING COMPANY LIMITED: collaborator
• MedProve Inc: collaborator

Study Sites (1)

NANOGEN Pharmaceutical Biotechnology JSC

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Bui V Pham, MD. PhD

  Nguyen Tri Phuong Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 19, 2022
• Study Start: August 8, 2019
• Primary Completion: November 23, 2022
• Study Completion: November 23, 2022
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)