A Study to Compare Efficacy and Safety of Nanogen's Darbepoetin Alfa With Aranesp® (Amgen) in the⦠(NCT05585645) | Clinical Trial Compass
CompletedPhase 3
A Study to Compare Efficacy and Safety of Nanogen's Darbepoetin Alfa With AranespĀ® (Amgen) in the Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis (CKD)
Vietnam214 participantsStarted 2019-08-08
Plain-language 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.
Who can participate
Age range18 Years ā 65 Years
SexALL
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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 ā„ 20%, serum ferritin ā„ 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 ā„ 160/90 mmHg).
* Patients treated with Darbepoetin alfa or r-HuEPO within 4 weeks prior to enrollment.
* Patients with Uncontrolled diabetes mellitus with HbA1C ā„ 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 malignaā¦
What they're measuring
1
The mean change Hemoglobin level from baseline to Week 24
Timeframe: Week 0 (Assessed predose)- Week 24
Trial details
NCT IDNCT05585645
SponsorNanogen Pharmaceutical Biotechnology Joint Stock Company