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

NCT05636891 | Completed Phase 1

• 1 other identifier: NNG06.1
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease

Keywords

darbepoetin alfa; Nanogen; CKD; dialysis; treatment of anemia

Outcome Measures

Primary Outcomes (2)

• PK parameters comparison between NNG-DEPO and Aranesp®: Cmax

  Serum peak concentrations (Cmax)

  IV:Assessed predose and at 0.25; 0.5; 4;12;24;48;96;144;240;336 hours postdose/ SC: Assessed predose and at 4;12;24;48;96;144;240;336 hours postdose

• PK parameters comparison between NNG-DEPO and Aranesp®: AUC(0, t)

  Area under the curve from 0 to t (AUC 0-t)

  IV:Assessed predose and at 0.25; 0.5; 4;12;24;48;96;144;240;336 hours postdose/ SC: Assessed predose and at 4;12;24;48;96;144;240;336 hours postdose

Secondary Outcomes (10)

• PD parameters comparison between NNG-DEPO and Aranesp®: Cmax of reticulocytes

  Assessed predose and at and at 24;48;96;144;240;336 hours postdose

• PD parameters comparison between NNG-DEPO and Aranesp®: AUC(0, t) of reticulocytes

  Assessed predose and at and at 24;48;96;144;240;336 hours postdose

• PD parameters comparison between NNG-DEPO and Aranesp®: Tmax of reticulocytes

  Assessed predose and at and at 24;48;96;144;240;336 hours postdose

• PK parameters comparison between NNG-DEPO and Aranesp®:Tmax

  IV:Assessed predose and at 0.25; 0.5; 4;12;24;48;96;144;240;336 hours postdose/ SC: Assessed predose and at 4;12;24;48;96;144;240;336 hours postdose

• PK parameters comparison between NNG-DEPO and Aranesp®: AUC(0,∞)

  IV:Assessed predose and at 0.25; 0.5; 4;12;24;48;96;144;240;336 hours postdose/ SC: Assessed predose and at 4;12;24;48;96;144;240;336 hours postdose

Study Arms (2)

Stimus

EXPERIMENTAL

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

Biological: Stimus

Aranesp

ACTIVE COMPARATOR

Control: Amgen's Aranesp® 10µg/0.4mL, 20µg/0.5mL, 40µg/0.4mL, 60µg/0.3mL, prefilled syringe

Biological: Stimus

Interventions

Stimus BIOLOGICAL

* 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)

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
• Clinical Research Consultants, Inc.: collaborator
• Clinical Research Viet Nam Skill Training And Consultant Company Limited: collaborator

Study Sites (1)

NANOGEN Pharmaceutical Biotechnology JSC

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• 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 13, 2022
• First Posted: December 5, 2022
• Study Start: September 19, 2021
• Primary Completion: November 23, 2022
• Study Completion: November 23, 2022
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

VN (1)