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 Aranesp® (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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 maligna…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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