Chronic Kidney DiseasePhase 4NCT07025460
Darbepoetin Alfa Once Monthly Dosing Schedule Maintains Hemoglobin Concentration Comparable to Every 2 Weeks Dosing Schedule in Advanced Chronic Kidney Disease Patients Not on Dialysis: A Multicenter, Phase 4 Study
A Phase 4 study testing darbepoetin alfa in people with Chronic Kidney Disease, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
This open-label, multicenter, single-arm phase 4 trial evaluated the efficacy and safety of once-monthly subcutaneous administration of darbepoetin alfa (DARB) compared with biweekly dosing in Korean patients with non-dialysis chronic kidney disease (ND-CKD) and anemia. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- darbepoetin alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Dec 2019to 18 Jan 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 19 years
- Diagnosis of chronic kidney disease (CKD) not requiring dialysis
- Estimated glomerular filtration rate (eGFR) ≤ 45 mL/min/1.73 m² (calculated using the MDRD formula)
- Mean hemoglobin (Hb) concentration ≤ 11.5 g/dL during the screening period Hb concentration ≥ 9.5 g/dL during the screening period Stable DARB dosing during screening (defined as <25% variation in dose)
- Serum ferritin ≥ 100 µg/L or transferrin saturation (TSAT) > 20%
- Serum vitamin B12 and folate levels above the lower limit of normal (screening only) Provided written informed consent prior to any study-specific procedures
Who cannot join
- Planned kidney transplantation or prior kidney transplant
- Uncontrolled hypertension (systolic BP > 180 mmHg or diastolic BP > 110 mmHg) Acute myocardial infarction or hospitalization for heart failure within the past 12 weeks
- Serum parathyroid hormone (PTH) > 1500 pg/mL (screening only) Active systemic infection
- Diagnosed hematologic diseases (e.g., sickle cell anemia, myelodysplastic syndrome, leukemia, multiple myeloma, hemolytic anemia)
- Major surgery within 12 weeks prior to screening (excluding vascular access surgery)
- Red blood cell transfusion within 8 weeks before screening or during the study period
Show all 9Show fewer
- Use of any investigational drug or medical device within 30 days prior to screening or during the study
- Active malignancy not in remission
- Total darbepoetin alfa dose > 180 mcg in the month prior to enrollment
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Institutional Review Board, Gangnam Severance Hospitial Yonsei University College of Medicine
Seoul
About this study
This open-label, multicenter, single-arm phase 4 trial evaluated the efficacy and safety of once-monthly subcutaneous administration of darbepoetin alfa (DARB) compared with biweekly dosing in Korean patients with non-dialysis chronic kidney disease (ND-CKD) and anemia.
Anemia in CKD is a major contributor to cardiovascular morbidity and mortality. Although DARB every-2-week dosing has been established as effective, once-monthly dosing may maintain Hb levels while improving patient adherence and reducing healthcare burden. No clinical data were previously available for the Korean population, which is rapidly aging and has a high prevalence of CKD.
Read more
Study Design:
A total of 65 patients entered a 12-week screening period during which they received DARB every 2 weeks. Of these, 40 patients met eligibility criteria (stable Hb ≥9.5 g/dL, <25% dose variation) and were enrolled into the 12-week evaluation phase with once-monthly DARB dosing. Dose adjustments were made based on Hb trends to maintain Hb within 10.0-11.0 g/dL. All 40 patients completed the study and were included in efficacy and safety analyses.
Primary Endpoint:
Proportion of participants maintaining Hb ≥10.0 g/dL at Week 25, assessed for non-inferiority with a prespecified margin of 0.2 g/dL.
Secondary Endpoints:
Mean Hb concentration during the evaluation phase (Weeks 13, 17, 21, and 25)
Response frequency
Proportion of patients with Hb <10 g/dL or >11 g/dL
Change in iron parameters (serum ferritin, transferrin saturation)
Total DARB dose administered
Requirement for oral iron supplementation
Incidence of adverse events and blood pressure changes
Eligibility Criteria:
Inclusion:
Age ≥19 years
Diagnosis of CKD not requiring dialysis
eGFR ≤45 mL/min/1.73m² (MDRD formula)
Mean Hb ≤11.5 g/dL during screening, with Hb ≥9.5 g/dL
Stable DARB dosing during screening (<25% variation)
Ferritin ≥100 µg/L or transferrin saturation (TSAT) >20%
Exclusion:
Non-CKD causes of anemia
Acute myocardial infarction or hospitalization for heart failure within the past 12 weeks
Hematologic diseases, active infection, or recent major surgery
RBC transfusion within 8 weeks prior to screening, or DARB >180 mcg in the month prior to enrollment
Uncontrolled hypertension
Active malignancy
Sample Size:
A total of 77 patients were planned for enrollment, accounting for an expected dropout rate of 20%. In practice, 65 patients entered screening, 40 patients were enrolled into the evaluation phase, and all 40 completed the study.
Safety Considerations:
No unexpected safety issues were identified. Blood pressure remained stable throughout the study. Potential risks such as cardiovascular complications and tumor progression were considered; patients with significant risk factors were excluded. All data were anonymized and securely protected.
Significance:
This study provides real-world evidence that once-monthly DARB is non-inferior to biweekly dosing for maintaining Hb in Korean patients with ND-CKD. Extending the dosing interval to monthly administration may improve patient adherence, reduce injection burden, and inform treatment strategies for anemia management in Korea's aging CKD population.
Read the detailed description
Study Design and Procedures
This was a prospective, open-label, multicenter, single-arm phase 4 clinical trial designed to evaluate the efficacy and safety of once-monthly subcutaneous darbepoetin alfa (DARB) compared with the established biweekly dosing schedule in Korean patients with anemia secondary to non-dialysis chronic kidney disease (ND-CKD).
Study Flow Summary
Screening Phase (Week -12 to 0):
A total of 65 patients received DARB every 2 weeks for 12 weeks. Eligibility required stable Hb levels (≥9.5 g/dL) with <25% dose variation during this period.
Enrollment (Week 0):
Forty patients who met all inclusion criteria and no exclusion criteria were enrolled into the evaluation phase and switched to once-monthly DARB dosing.
Evaluation Phase (Week 1 to 12):
Patients received once-monthly DARB for 12 weeks with predefined dose adjustments to maintain Hb within 10.0-11.0 g/dL.
Follow-up Visits:
Assessments were performed at Weeks 13, 17, 21, and 25.
Dosing Schedule
Initial monthly dose was based on the cumulative biweekly dose administered during the final month of the screening phase.
Dose titration rules:
Hb <10.0 g/dL → increase to next higher dose
Hb 10.0-11.0 g/dL → maintain current dose
Hb >11.0-12.0 g/dL → reduce to next lower dose
Hb >12.0 g/dL → temporarily withhold, reinitiate at lower dose once Hb ≤12.0 g/dL
Available doses: 20, 30, 40, 60, and 120 mcg (prefilled syringes).
Laboratory and Clinical Assessments
Hemoglobin, serum iron, ferritin, transferrin saturation (TSAT), TIBC, creatinine, eGFR (MDRD), and blood pressure were measured at scheduled visits.
Safety assessments included adverse event monitoring, physical examinations, and routine laboratory tests.
Statistical Considerations
Primary endpoint: Proportion of patients maintaining Hb ≥10.0 g/dL at Week 25, analyzed for non-inferiority with a prespecified margin of 0.2 g/dL.
Secondary endpoints: Mean Hb, iron parameters, response frequency, total DARB dose, oral iron requirements, and safety outcomes including adverse events and blood pressure changes.
Analysis sets:
Full Analysis Set (FAS): All 40 enrolled patients who received ≥1 dose and had ≥1 post-baseline Hb measurement.
Per-Protocol (PP) Set: Patients in the FAS without major protocol deviations who completed the study.
Missing data were imputed using Next Observation Carried Backward (NOCB).
Study Completion
Of the 65 patients screened, 40 entered the evaluation phase and all 40 completed the study, allowing full assessment of efficacy and safety outcomes.
Significance
This trial demonstrates that once-monthly darbepoetin alfa is non-inferior to biweekly dosing for maintaining hemoglobin in Korean patients with ND-CKD. These findings support the feasibility of extending the dosing interval to monthly administration, potentially improving adherence and reducing treatment burden in real-world practice.
- Conditions
- Chronic Kidney Disease
- Being tested
- darbepoetin alfa
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
darbepoetin alfaDrug
Participants receive darbepoetin alfa administered subcutaneously once every 4 weeks for 12 weeks during the evaluation phase. Dose adjustments are made to maintain hemoglobin levels within 10.0-11.0 g/dL.
| Study group | Role | What they receive |
|---|---|---|
| Once-monthly darbepoetin alfa group | Experimental | Participants receive darbepoetin alfa administered subcutaneously once every 4 weeks for 12 weeks. Initial dose is based on prior month's cumulative dose. Dose adjustments are made based on hemoglobin levels to maintain Hb within 10.0-11.0 g/dL. Receives: Drug: darbepoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants maintaining hemoglobin (Hb) ≥10.0 g/dL at Week 25
The primary endpoint is the proportion of participants whose hemoglobin (Hb) concentration is maintained at or above 10.0 g/dL at Week 25 following once-monthly subcutaneous administration of darbepoetin alfa. Non-inferiority was assessed using a prespecified margin of 0.2 g/dL.
Measured: Week 25 (end of 12-week evaluation phase)
Secondary outcomes (3)
Hemoglobin profile during the evaluation phase
Mean hemoglobin concentration at each visit and the proportion of participants outside the target range (Hb <10 g/dL or >11 g/dL).
Measured: Weeks 13, 17, 21, and 25
Iron metabolism and treatment requirements
Changes in serum ferritin and transferrin saturation (TSAT), total darbepoetin alfa dose administered, and proportion of participants requiring oral iron supplementation.
Measured: Weeks 13-25
Safety outcomes
Incidence, type, and severity of adverse events (AEs), and changes in systolic and diastolic blood pressure during the evaluation phase.
Measured: Weeks 1-25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start19 Dec 2019
- Primary completion17 Oct 2024
- Study completion18 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study uses a single-group, open-label design in which all enrolled participants receive the investigational intervention-subcutaneous administration of darbepoetin alfa once monthly. After a 12-week screening phase with biweekly dosing to confirm hemoglobin stability and dosing consistency, eligible participants are transitioned to once-monthly dosing for a 12-week evaluation period. There is no comparator or randomization. All participants receive the same treatment protocol, and outcomes are assessed within this single cohort.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoon Young Choi, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025460
- Sponsor's protocol ID
- 3-2019-0358
- Status last verified
- Sep 2025
- First submitted
- 9 Jun 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hertel J, Locay H, Scarlata D, Jackson L, Prathikanti R, Audhya P. Darbepoetin alfa administered every other week maintains hemoglobin levels over 52 weeks in patients with chronic kidney disease converting from once-weekly recombinant human erythropoietin: results from simplify the treatment of anemia with Aranesp (STAAR). Am J Nephrol. 2006;26(2):149-56. doi: 10.1159/000092852. Epub 2006 Apr 21.
PubMed 16636531Roger SD, Kolmakova E, Fung M, Malecki R, Vinhas J, Dellanna F, Thomas M, Manamley N, Ferenczi S. Darbepoetin alfa once monthly corrects anaemia in patients with chronic kidney disease not on dialysis. Nephrology (Carlton). 2014 May;19(5):266-74. doi: 10.1111/nep.12214.
PubMed 24506498
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Darbepoetin Alfa Once Monthly Dosing Schedule Maintains Hemoglobin Concentration Comparable to Every 2 Weeks Dosing Schedule in Advanced Chronic Kidney Disease Patients Not on Dialysis: A Multicenter, Phase 4 Study
- ClinicalTrials.gov ID
- NCT07025460
- Acronym / sponsor ID
- 3-2019-0358
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 18 Jan 2026 (estimated)
- First posted
- 17 Jun 2025 (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 open-label, multicenter, single-arm phase 4 trial evaluated the efficacy and safety of once-monthly subcutaneous administration of darbepoetin alfa (DARB) compared with biweekly dosing in Korean patients with non-dialysis chronic kidney disease (ND-CKD) and anemia.
Anemia in CKD is a major contributor to cardiovascular morbidity and mortality. Although DARB every-2-week dosing has been established as effective, once-monthly dosing may maintain Hb levels while improving patient adherence and reducing healthcare burden. No clinical data were previously available for the Korean population, which is rapidly aging and has a high prevalence of CKD.
Study Design:
A total of 65 patients entered a 12-week screening period during which they received DARB every 2 weeks. Of these, 40 patients met eligibility criteria (stable Hb ≥9.5 g/dL, <25% dose variation) and were enrolled into the 12-week evaluation phase with once-monthly DARB dosing. Dose adjustments were made based on Hb trends to maintain Hb within 10.0-11.0 g/dL. All 40 patients completed the study and were included in efficacy and safety analyses.
Primary Endpoint:
Proportion of participants maintaining Hb ≥10.0 g/dL at Week 25, assessed for non-inferiority with a prespecified margin of 0.2 g/dL.
Secondary Endpoints:
Mean Hb concentration during the evaluation phase (Weeks 13, 17, 21, and 25)
Response frequency
Proportion of patients with Hb <10 g/dL or >11 g/dL
Change in iron parameters (serum ferritin, transferrin saturation)
Total DARB dose administered
Requirement for oral iron supplementation
Incidence of adverse events and blood pressure changes
Eligibility Criteria:
Inclusion:
Age ≥19 years
Diagnosis of CKD not requiring dialysis
eGFR ≤45 mL/min/1.73m² (MDRD formula)
Mean Hb ≤11.5 g/dL during screening, with Hb ≥9.5 g/dL
Stable DARB dosing during screening (<25% variation)
Ferritin ≥100 µg/L or transferrin saturation (TSAT) >20%
Exclusion:
Non-CKD causes of anemia
Acute myocardial infarction or hospitalization for heart failure within the past 12 weeks
Hematologic diseases, active infection, or recent major surgery
RBC transfusion within 8 weeks prior to screening, or DARB >180 mcg in the month prior to enrollment
Uncontrolled hypertension
Active malignancy
Sample Size:
A total of 77 patients were planned for enrollment, accounting for an expected dropout rate of 20%. In practice, 65 patients entered screening, 40 patients were enrolled into the evaluation phase, and all 40 completed the study.
Safety Considerations:
No unexpected safety issues were identified. Blood pressure remained stable throughout the study. Potential risks such as cardiovascular complications and tumor progression were considered; patients with significant risk factors were excluded. All data were anonymized and securely protected.
Significance:
This study provides real-world evidence that once-monthly DARB is non-inferior to biweekly dosing for maintaining Hb in Korean patients with ND-CKD. Extending the dosing interval to monthly administration may improve patient adherence, reduce injection burden, and inform treatment strategies for anemia management in Korea's aging CKD population.
Detailed description
Study Design and Procedures
This was a prospective, open-label, multicenter, single-arm phase 4 clinical trial designed to evaluate the efficacy and safety of once-monthly subcutaneous darbepoetin alfa (DARB) compared with the established biweekly dosing schedule in Korean patients with anemia secondary to non-dialysis chronic kidney disease (ND-CKD).
Study Flow Summary
Screening Phase (Week -12 to 0):
A total of 65 patients received DARB every 2 weeks for 12 weeks. Eligibility required stable Hb levels (≥9.5 g/dL) with <25% dose variation during this period.
Enrollment (Week 0):
Forty patients who met all inclusion criteria and no exclusion criteria were enrolled into the evaluation phase and switched to once-monthly DARB dosing.
Evaluation Phase (Week 1 to 12):
Patients received once-monthly DARB for 12 weeks with predefined dose adjustments to maintain Hb within 10.0-11.0 g/dL.
Follow-up Visits:
Assessments were performed at Weeks 13, 17, 21, and 25.
Dosing Schedule
Initial monthly dose was based on the cumulative biweekly dose administered during the final month of the screening phase.
Dose titration rules:
Hb <10.0 g/dL → increase to next higher dose
Hb 10.0-11.0 g/dL → maintain current dose
Hb >11.0-12.0 g/dL → reduce to next lower dose
Hb >12.0 g/dL → temporarily withhold, reinitiate at lower dose once Hb ≤12.0 g/dL
Available doses: 20, 30, 40, 60, and 120 mcg (prefilled syringes).
Laboratory and Clinical Assessments
Hemoglobin, serum iron, ferritin, transferrin saturation (TSAT), TIBC, creatinine, eGFR (MDRD), and blood pressure were measured at scheduled visits.
Safety assessments included adverse event monitoring, physical examinations, and routine laboratory tests.
Statistical Considerations
Primary endpoint: Proportion of patients maintaining Hb ≥10.0 g/dL at Week 25, analyzed for non-inferiority with a prespecified margin of 0.2 g/dL.
Secondary endpoints: Mean Hb, iron parameters, response frequency, total DARB dose, oral iron requirements, and safety outcomes including adverse events and blood pressure changes.
Analysis sets:
Full Analysis Set (FAS): All 40 enrolled patients who received ≥1 dose and had ≥1 post-baseline Hb measurement.
Per-Protocol (PP) Set: Patients in the FAS without major protocol deviations who completed the study.
Missing data were imputed using Next Observation Carried Backward (NOCB).
Study Completion
Of the 65 patients screened, 40 entered the evaluation phase and all 40 completed the study, allowing full assessment of efficacy and safety outcomes.
Significance
This trial demonstrates that once-monthly darbepoetin alfa is non-inferior to biweekly dosing for maintaining hemoglobin in Korean patients with ND-CKD. These findings support the feasibility of extending the dosing interval to monthly administration, potentially improving adherence and reducing treatment burden in real-world practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study uses a single-group, open-label design in which all enrolled participants receive the investigational intervention-subcutaneous administration of darbepoetin alfa once monthly. After a 12-week screening phase with biweekly dosing to confirm hemoglobin stability and dosing consistency, eligible participants are transitioned to once-monthly dosing for a 12-week evaluation period. There is no comparator or randomization. All participants receive the same treatment protocol, and outcomes are assessed within this single cohort.
| Arm | Type | Receives |
|---|---|---|
| Once-monthly darbepoetin alfa group | Experimental | Drug: darbepoetin alfaParticipants receive darbepoetin alfa administered subcutaneously once every 4 weeks for 12 weeks. Initial dose is based on prior month's cumulative dose. Dose adjustments are made based on hemoglobin levels to maintain Hb within 10.0-11.0 g/dL. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 19 years
- Diagnosis of chronic kidney disease (CKD) not requiring dialysis
- Estimated glomerular filtration rate (eGFR) ≤ 45 mL/min/1.73 m² (calculated using the MDRD formula)
- Mean hemoglobin (Hb) concentration ≤ 11.5 g/dL during the screening period Hb concentration ≥ 9.5 g/dL during the screening period Stable DARB dosing during screening (defined as <25% variation in dose)
- Serum ferritin ≥ 100 µg/L or transferrin saturation (TSAT) > 20%
Key exclusion criteria (9 listed)
- Planned kidney transplantation or prior kidney transplant
- Uncontrolled hypertension (systolic BP > 180 mmHg or diastolic BP > 110 mmHg) Acute myocardial infarction or hospitalization for heart failure within the past 12 weeks
- Serum parathyroid hormone (PTH) > 1500 pg/mL (screening only) Active systemic infection
- Diagnosed hematologic diseases (e.g., sickle cell anemia, myelodysplastic syndrome, leukemia, multiple myeloma, hemolytic anemia)
- Major surgery within 12 weeks prior to screening (excluding vascular access surgery)
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 |
|---|---|---|
| darbepoetin alfaParticipants receive darbepoetin alfa administered subcutaneously once every 4 weeks for 12 weeks during the evaluation phase. Dose adjustments are made to maintain hemoglobin levels within 10.0-11.0 g/dL. | Drug | Once-monthly darbepoetin alfa group |
Primary outcome
Proportion of participants maintaining hemoglobin (Hb) ≥10.0 g/dL at Week 25
Time frame: Week 25 (end of 12-week evaluation phase)
The primary endpoint is the proportion of participants whose hemoglobin (Hb) concentration is maintained at or above 10.0 g/dL at Week 25 following once-monthly subcutaneous administration of darbepoetin alfa. Non-inferiority was assessed using a prespecified margin of 0.2 g/dL.
3 secondary outcomes
Hemoglobin profile during the evaluation phase
Time frame: Weeks 13, 17, 21, and 25
Iron metabolism and treatment requirements
Time frame: Weeks 13-25
Safety outcomes
Time frame: Weeks 1-25
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Background: PubMed 16636531Hertel J, Locay H, Scarlata D, Jackson L, Prathikanti R, Audhya P. Darbepoetin alfa administered every other week maintains hemoglobin levels over 52 weeks in patients with chronic kidney disease converting from once-weekly recombinant human erythropoietin: results from simplify the treatment of anemia with Aranesp (STAAR). Am J Nephrol. 2006;26(2):149-56. doi: 10.1159/000092852. Epub 2006 Apr 21.
- Background: PubMed 24506498Roger SD, Kolmakova E, Fung M, Malecki R, Vinhas J, Dellanna F, Thomas M, Manamley N, Ferenczi S. Darbepoetin alfa once monthly corrects anaemia in patients with chronic kidney disease not on dialysis. Nephrology (Carlton). 2014 May;19(5):266-74. doi: 10.1111/nep.12214.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing darbepoetin alfa in people with Chronic Kidney Disease, run by Gangnam Severance Hospital at 1 site in South Korea.
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 6 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2025. 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of participants maintaining hemoglobin (Hb) ≥10.0 g/dL at Week 25 (time frame: Week 25 (end of 12-week evaluation phase)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07025460, which also lists 2 linked publications.
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 24 Sep 2025.