Trial · NCT07025460
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, Phase 4, Active not recruiting, Gangnam Severance Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT07025460. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07025460
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT07025460
- Status
- Active not recruiting
- Phases
- Phase 4
- Enrollment
- 40 participants, actual
- Lead sponsor
- Gangnam Severance Hospital
- Conditions
- Chronic Kidney Disease
- Interventions
- darbepoetin alfa
- First posted
- 2025-06-17
- Last updated
- 2025-09-24
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of participants maintaining hemoglobin (Hb) ≥10.0 g/dL at Week 25 | 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. |
| Secondary | Hemoglobin profile during the evaluation phase | Weeks 13, 17, 21, and 25 | Mean hemoglobin concentration at each visit and the proportion of participants outside the target range (Hb \<10 g/dL or \>11 g/dL). |
| Secondary | Iron metabolism and treatment requirements | Weeks 13-25 | Changes in serum ferritin and transferrin saturation (TSAT), total darbepoetin alfa dose administered, and proportion of participants requiring oral iron supplementation. |
| Secondary | Safety outcomes | Weeks 1-25 | Incidence, type, and severity of adverse events (AEs), and changes in systolic and diastolic blood pressure during the evaluation phase. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07025460
GET https://conductscience.org/api/trials/v1/NCT07025460/registered