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Search / Trial NCT05636891

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

Trial Information

Current as of January 17, 2025

Unknown status

Keywords

Darbepoetin Alfa Nanogen Ckd Dialysis Treatment Of Anemia

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.

About Nanogen Pharmaceutical Biotechnology Joint Stock Company

Nanogen Pharmaceutical Biotechnology Joint Stock Company is a leading biopharmaceutical firm dedicated to the development and commercialization of innovative therapeutic solutions. With a strong emphasis on research and development, Nanogen leverages advanced biotechnology to create cutting-edge treatments in areas such as oncology, infectious diseases, and chronic conditions. The company is committed to improving patient outcomes through rigorous clinical trials and collaborations with global research institutions, ensuring that its products meet the highest standards of safety and efficacy. Driven by a mission to enhance healthcare accessibility, Nanogen aims to deliver transformative therapies that address unmet medical needs both locally and internationally.

Locations

Ho Chi Minh City, , Vietnam

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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