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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

NCT07025460 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-24

No results posted yet for this study

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.

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.

Conditions

Interventions

DRUG

darbepoetin alfa

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.

Sponsors & Collaborators

  • Gangnam Severance Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-19
Primary Completion
2024-10-17
Completion
2026-01-18

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07025460 on ClinicalTrials.gov