Can a new drug match a standard anemia treatment for dialysis patients?
NCT ID NCT05585645
First seen Aug 21, 2026 · Last updated Aug 21, 2026
Summary
This trial is testing whether a new version of darbepoetin alfa works as well as the standard treatment (Aranesp) for anemia in people with chronic kidney disease who are on dialysis. Participants will receive either the new drug or Aranesp by injection every other week for 24 weeks. The goal is to see if the new drug can safely maintain healthy hemoglobin levels, reducing the need for blood transfusions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- darbepoetin alfa (a drug that stimulates red blood cell production)
- What this could lead to
- If successful, this could offer a more affordable or accessible treatment option for anemia in dialysis patients, potentially improving their quality of life.
- What could go wrong
- This is a Phase 3 trial, but results may not show the new drug is as effective or safe as Aranesp. Individual responses can vary, and there are risks like high blood pressure or blood clots.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
214 people
The number who actually took part.
- Started
-
Aug 2019
- Finished
-
Nov 2022
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
NANOGEN Pharmaceutical Biotechnology JSC
Ho Chi Minh City, Vietnam
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Other studies related to the condition(s) this trial covers.
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