Pharmacokinetic/Pharmacodynamic Parameters of NNG-DEPO (Stimus) With Aranesp® (Amgen) in Treatment of Anemia in CKD Patients on Dialysis
- Conditions
- Chronic Kidney Disease
- Interventions
- Biological: Stimus
- Registration Number
- NCT05636891
- 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.
- Detailed 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 43
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stimus Stimus Treatment: Nanogen's Darbepoetin alfa 10µg/0.4mL, 20µg/0.5mL, 40µg/0.4mL, 60µg/0.3mL, prefilled syringe Aranesp Stimus Control: Amgen's Aranesp® 10µg/0.4mL, 20µg/0.5mL, 40µg/0.4mL, 60µg/0.3mL, prefilled syringe
- Primary Outcome Measures
Name Time Method PK parameters comparison between NNG-DEPO and Aranesp®: 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 Serum peak concentrations (Cmax)
PK parameters comparison between NNG-DEPO and Aranesp®: 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 Area under the curve from 0 to t (AUC 0-t)
- Secondary Outcome Measures
Name Time Method 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 Area under the curve from 0 to ∞ (AUC0-∞)
PK parameters comparison between NNG-DEPO and Aranesp®: λz. 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 λz.
Proportion of the adverse events (AE) including physical examinations, vital signs, and clinical laboratory investigations. Week 0 (Assessed predose)- Week 24] Rate of AE and SAE occurence
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 Serum peak concentrations (Cmax) of reticulocytes
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 Time for the drug to reach peak concentration (Tmax) of reticulocytes
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 Area under the curve from 0 to t (AUC 0-t) of reticulocytes
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 Time for the drug to reach peak concentration (Tmax)
PK parameters comparison between NNG-DEPO and Aranesp®:Vz/F 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 Vz/F
PK parameters comparison between NNG-DEPO and Aranesp®:T1/2 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 Half-life (T1/2)
PK parameters comparison between NNG-DEPO and Aranesp®: CL/F 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 CL/F
Trial Locations
- Locations (1)
NANOGEN Pharmaceutical Biotechnology JSC
🇻🇳Ho Chi Minh City, Vietnam