Pharmacokinetic/Pharmacodynamic Parameters of NNG-DEPO (Stimus) With Aranesp® (Amgen) in Treatmen… (NCT05636891) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetic/Pharmacodynamic Parameters of NNG-DEPO (Stimus) With Aranesp® (Amgen) in Treatment of Anemia in CKD Patients on Dialysis
Vietnam43 participantsStarted 2021-09-19
Plain-language 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.
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 malignanc…
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
PK parameters comparison between NNG-DEPO and Aranesp®: Cmax
Timeframe: 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
2
PK parameters comparison between NNG-DEPO and Aranesp®: AUC(0, t)
Timeframe: 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
Trial details
NCT IDNCT05636891
SponsorNanogen Pharmaceutical Biotechnology Joint Stock Company