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Monthly injection may ease anemia treatment for kidney patients

NCT ID NCT07025460

Disease control Sponsor: Gangnam Severance Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This phase 4 study tested whether a once-monthly injection of darbepoetin alfa works as well as the standard every-2-week schedule for maintaining healthy hemoglobin levels in people with advanced chronic kidney disease who are not on dialysis. Forty Korean adults completed the 12-week evaluation phase. The goal was to see if the monthly dosing could keep hemoglobin at or above 10.0 g/dL, which would mean fewer injections and less burden for patients.

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
What this could lead to
If successful, this could offer a more convenient once-monthly injection schedule for managing anemia in chronic kidney disease, potentially improving patient adherence and reducing healthcare visits.
What could go wrong
This is a small, single-arm study in a specific Korean population, so results may not apply broadly. The trial is already complete, and while it showed non-inferiority, larger studies would be needed to confirm safety and effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

40 people

The number who actually took part.

Started

Dec 2019

Expected to finish

Jan 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Female participants only

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease

Contacts and locations

Locations

  • Institutional Review Board, Gangnam Severance Hospitial Yonsei University College of Medicine

    Seoul, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.