AnemiaPhase 3NCT05585645
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)
A Phase 3 study testing Stimus (NNG-DEPO) in people with Anemia and Chronic Kidney Disease Requiring Chronic Dialysis, run by Nanogen Pharmaceutical Biotechnology Joint Stock Company at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anemia, Chronic Kidney Disease Requiring Chronic Dialysis
- What is being tested?
- Stimus (NNG-DEPO)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteVietnam
- Study dates
- 8 Aug 2019to 23 Nov 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Double-blind, Randomized, Parallel Comparative Study of Efficacy and Safety of Nanogen's Darbepoetin Alfa With Aranesp® (Amgen) in the Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis
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.
Read the detailed description
The phase of the study: phase 3
Study sites:
Nguyen Tri Phuong Hospital Thu Duc City Hospital An Sinh Hospital Thong Nhat General Hospital Dong Nai
Sample size: 214 patients
TARGET POPULATION: Patients with chronic kidney disease undergoing dialysis (aged 18 to 65 years)
STUDY GROUPS:
Darbepoetin alfa (Nanogen) SC/IV route 0.75 µg/kg Q2W, for 24 weeks. Aranesp® (Amgen) SC/IV route 0.75 µg/kg Q2W, for 24 weeks.
Blood sample will be taken for Complete Blood Count (CBC) test at each visit (Week 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24) to monitor haemoglobin response.
Study Procedures:
This study was designed for 26 weeks (2 weeks for screening and 24 weeks for treatment) and there are total of 14 visits:
Visit 1 is the screening visit. Visit 2: Randomization, initiate study treatment, assess the Hb baseline. Visit 3 - 7 is to monitor, evaluate the efficacy, safety. Visit 8 is to interim assess the efficacy, safety for each patient to make the decision continous/discontinous the study treatment.
Vist 9 -13 is to monitor, evaluate the efficacy, safety. Visit 14 is termination visit.
SAFETY AND TOLERABILITY ASSESSMENT:
Safety and tolerability assessments will be performed at each visit. Following variables will be considered to define the safety and tolerability of investigational drugs:
Clinical adverse events (AEs): frequency of AEs, overall and by intensity. Severe clinical adverse events (SAEs): frequency of AEs, overall and by intensity.
Symptoms directed physical examination including body weight, and vital signs during treatment period: mean change from baseline and the frequency of clinically relevant changes from baseline.
Laboratory tests: frequency of clinically relevant changes from baseline. The frequency of any concomitant medication administered to treat any adverse events.
Presence of darbepoetin alfa anti-bodies (immunogenicity).
- Being tested
- Stimus (NNG-DEPO)
- Keywords
- CKD on dialysis, Nanogen, Anemia, Darbepoetin Alfa
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimus (NNG-DEPO)Biological
Nanogen's Darbepoetin alfa 10µg/0.4mL, 20µg/0.5mL, 40µg/0.4mL, 60µg/0.3mL, prefilled syringe
| Study group | Role | What they receive |
|---|---|---|
| Stimus | Experimental | NNG-DEPO (Darbepoetin alfa 10 mcg/0.4 mL, 20 mcg/0.5 mL, 40 mcg/0.4 mL, 60 mcg/0.3 mL) is available as a prefilled syringe in a sterile, colorless, glass tube.
Storage: 2-8ºC, not frozen. The process of transporting and storing the drug must ensure the temperature in the range of 2-8ºC.
NNG-DEPO/Aranesp is administered subcutaneously (or intravenously) at a dose of 0.75 g/kg initially, every 2 weeks at the second visit.
Study drug will be prepared according to standard procedure (SOP). Dosage adjustment guideline:
Patients will have hemoglobin levels monitored every 2 weeks. The investigators will evaluate and adjust the dose of Darbepoetin alfa to maintain the Hb levels within the target range (10 - 12 g/dL) Receives: Biological: Stimus (NNG-DEPO) |
| Aranesp | Active comparator | Aranesp® (Darbepoetin alfa 10 mcg/ 0.4 mL, 20 mcg/ 0.5 mL, 40 mcg/ 0.4 mL, 60 mcg/ 0.3 mL) is manufactured by Amgen, as a pre-filled syringe in a sterile, glass tube, colourless.
Storage: 2-8ºC, not frozen. The process of transporting and storing the drug must ensure the temperature in the range of 2-8ºC.
NNG-DEPO/Aranesp is administered subcutaneously (or intravenously) at a dose of 0.75 g/kg initially, every 2 weeks at the second visit.
Study drug will be prepared according to standard procedure (SOP). Dosage adjustment guideline:
Patients will have hemoglobin levels monitored every 2 weeks. The investigators will evaluate and adjust the dose of Darbepoetin alfa to maintain the Hb levels within the target range (10 - 12 g/dL) Receives: Biological: Stimus (NNG-DEPO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change Hemoglobin level from baseline to Week 24
Measured: Week 0 (Assessed predose)- Week 24
Secondary outcomes (7)
Proportion of patients achieving 1 g/dL rise in Hb from baseline during 24 weeks after treatment
Measured: Week 0 (Assessed predose)- Week 24
Proportion of patients achieving Hb within the target range (10 - 12 g/dL) at week 24.
Measured: Week 24
Proportion of patients need for blood transfusion during 24 weeks after treatment.
Measured: Week 0 (Assessed predose)- Week 24
4. The mean dose of NNG-DEPO/Aranesp administered for achievement of Hb in the target Hb levels (10 - 12 g/dL) during 24 weeks.
Measured: Week 0 (Assessed predose)- Week 24
Time to initial achievement of Hb ≥ 11 g/dL.
Measured: Week 0 (Assessed predose)- Week 24
Proportion of the adverse events (AE) including physical examinations, vital signs, and clinical laboratory investigations.
Measured: Week 0 (Assessed predose)- Week 24
Proportion of patients positive with anti-Darbepoetin alfa antibody after treatment.
Measured: Week 0 (Assessed predose)- Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start8 Aug 2019
- Primary completion23 Nov 2022
- Study completion23 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanogen Pharmaceutical Biotechnology Joint Stock Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vietstar Biomedical Research, MEDPHASE CLINICAL RESEARCH CONSULTANT COMPANY LIMITED, CLINICAL RESEARCH VIET NAM SKILL TRAINING AND CONSULTING COMPANY LIMITED, MedProve Inc
- Responsible party
- Sponsor
- Investigators
- Bui V Pham, MD. PhD, Principal investigator, Nguyen Tri Phuong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585645
- Sponsor's protocol ID
- NNG06.2
- Status last verified
- Mar 2025
- First submitted
- 14 Oct 2022
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not yet infomation
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Parallel Comparative Study of Efficacy and Safety of Nanogen's Darbepoetin Alfa With Aranesp® (Amgen) in the Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis
- ClinicalTrials.gov ID
- NCT05585645
- Acronym / sponsor ID
- NNG06.2
- Keywords
- CKD on dialysis, Nanogen, Anemia, Darbepoetin Alfa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Nanogen Pharmaceutical Biotechnology Joint Stock CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Vietstar Biomedical Research, MEDPHASE CLINICAL RESEARCH CONSULTANT COMPANY LIMITED, CLINICAL RESEARCH VIET NAM SKILL TRAINING AND CONSULTING COMPANY LIMITED, MedProve Inc
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The phase of the study: phase 3
Study sites:
Nguyen Tri Phuong Hospital Thu Duc City Hospital An Sinh Hospital Thong Nhat General Hospital Dong Nai
Sample size: 214 patients
TARGET POPULATION: Patients with chronic kidney disease undergoing dialysis (aged 18 to 65 years)
STUDY GROUPS:
Darbepoetin alfa (Nanogen) SC/IV route 0.75 µg/kg Q2W, for 24 weeks. Aranesp® (Amgen) SC/IV route 0.75 µg/kg Q2W, for 24 weeks.
Blood sample will be taken for Complete Blood Count (CBC) test at each visit (Week 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24) to monitor haemoglobin response.
Study Procedures:
This study was designed for 26 weeks (2 weeks for screening and 24 weeks for treatment) and there are total of 14 visits:
Visit 1 is the screening visit. Visit 2: Randomization, initiate study treatment, assess the Hb baseline. Visit 3 - 7 is to monitor, evaluate the efficacy, safety. Visit 8 is to interim assess the efficacy, safety for each patient to make the decision continous/discontinous the study treatment.
Vist 9 -13 is to monitor, evaluate the efficacy, safety. Visit 14 is termination visit.
SAFETY AND TOLERABILITY ASSESSMENT:
Safety and tolerability assessments will be performed at each visit. Following variables will be considered to define the safety and tolerability of investigational drugs:
Clinical adverse events (AEs): frequency of AEs, overall and by intensity. Severe clinical adverse events (SAEs): frequency of AEs, overall and by intensity.
Symptoms directed physical examination including body weight, and vital signs during treatment period: mean change from baseline and the frequency of clinically relevant changes from baseline.
Laboratory tests: frequency of clinically relevant changes from baseline. The frequency of any concomitant medication administered to treat any adverse events.
Presence of darbepoetin alfa anti-bodies (immunogenicity).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimus | Experimental | Biological: Stimus (NNG-DEPO)NNG-DEPO (Darbepoetin alfa 10 mcg/0.4 mL, 20 mcg/0.5 mL, 40 mcg/0.4 mL, 60 mcg/0.3 mL) is available as a prefilled syringe in a sterile, colorless, glass tube. Storage: 2-8ºC, not frozen. The process of transporting and storing the drug must ensure the temperature in the range of 2-8ºC. NNG-DEPO/Aranesp is administered subcutaneously (or intravenously) at a dose of 0.75 g/kg initially, every 2 weeks at the second visit. Study drug will be prepared according to standard procedure (SOP). Dosage adjustment guideline: Patients will have hemoglobin levels monitored every 2 weeks. The investigators will evaluate and adjust the dose of Darbepoetin alfa to maintain the Hb levels within the target range (10 - 12 g/dL) |
| Aranesp | Active comparator | Biological: Stimus (NNG-DEPO)Aranesp® (Darbepoetin alfa 10 mcg/ 0.4 mL, 20 mcg/ 0.5 mL, 40 mcg/ 0.4 mL, 60 mcg/ 0.3 mL) is manufactured by Amgen, as a pre-filled syringe in a sterile, glass tube, colourless. Storage: 2-8ºC, not frozen. The process of transporting and storing the drug must ensure the temperature in the range of 2-8ºC. NNG-DEPO/Aranesp is administered subcutaneously (or intravenously) at a dose of 0.75 g/kg initially, every 2 weeks at the second visit. Study drug will be prepared according to standard procedure (SOP). Dosage adjustment guideline: Patients will have hemoglobin levels monitored every 2 weeks. The investigators will evaluate and adjust the dose of Darbepoetin alfa to maintain the Hb levels within the target range (10 - 12 g/dL) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stimus (NNG-DEPO)Nanogen's Darbepoetin alfa 10µg/0.4mL, 20µg/0.5mL, 40µg/0.4mL, 60µg/0.3mL, prefilled syringe | Biological | Aranesp, Stimus |
Primary outcome
The mean change Hemoglobin level from baseline to Week 24
Time frame: Week 0 (Assessed predose)- Week 24
7 secondary outcomes
Proportion of patients achieving 1 g/dL rise in Hb from baseline during 24 weeks after treatment
Time frame: Week 0 (Assessed predose)- Week 24
Proportion of patients achieving Hb within the target range (10 - 12 g/dL) at week 24.
Time frame: Week 24
Proportion of patients need for blood transfusion during 24 weeks after treatment.
Time frame: Week 0 (Assessed predose)- Week 24
4. The mean dose of NNG-DEPO/Aranesp administered for achievement of Hb in the target Hb levels (10 - 12 g/dL) during 24 weeks.
Time frame: Week 0 (Assessed predose)- Week 24
Time to initial achievement of Hb ≥ 11 g/dL.
Time frame: Week 0 (Assessed predose)- Week 24
Proportion of the adverse events (AE) including physical examinations, vital signs, and clinical laboratory investigations.
Time frame: Week 0 (Assessed predose)- Week 24
Proportion of patients positive with anti-Darbepoetin alfa antibody after treatment.
Time frame: Week 0 (Assessed predose)- Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No. Not yet infomation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bui V Pham, MD. PhD principal investigator
Nguyen Tri Phuong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stimus (NNG-DEPO) in people with Anemia and Chronic Kidney Disease Requiring Chronic Dialysis, run by Nanogen Pharmaceutical Biotechnology Joint Stock Company at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean change Hemoglobin level from baseline to Week 24 (time frame: Week 0 (Assessed predose)- Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.