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

Launched by NANOGEN PHARMACEUTICAL BIOTECHNOLOGY JOINT STOCK COMPANY · Nov 23, 2022

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 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.
• • Exclusion Criteria
• • 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.
• • Patients using drugs that can affect the concentration of Hb in the blood (except blood-forming drugs such as iron, folic acid).
• • Patients with seropositivity to HIV, HBV or anti-HCV.
• • Patients having acute tuberculosis or any acute bacterial infection within 1 month prior to the screening.
• • Patient has occult blood in stool or any other known source of internal bleeding and confirmed gastrointestinal bleeding by endoscopy.
• • Patients with blood transfusion due to acute bleeding within 12 weeks prior to screening period.
• • Patients with a history of immunosuppressive therapy within 1 month.
• • The patient is suffering from advanced cancer.
• • Patients having participated in any other clinical trial within 1 month prior to the screening period.
• • The patient had any medical condition that the investigator assessed as affecting the study.