CKD AnemiaNCT07517744
Comparison Between Darbapoeitin Alpha and Roxadustat in CKD-related Anemia
An observational study of CKD Anemia and CKD Anemia in Stable Dialysis Patients, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this prospective cohort clinical trial is to compare the effects of roxadustat and darbepoetin alfa on hematological and iron-related parameters in adults with end-stage kidney disease (ESKD) receiving maintenance hemodialysis who have erythropoietin-resistant anemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CKD Anemia, CKD Anemia in Stable Dialysis Patients
- What is being tested?
- Roxadustat and Darbepoetin Alfa Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2026to 10 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Egyptian patients with ESKD- or HD-related anemia who follow up at the Electricity hospital.
Who may be able to join
- End-stage kidney disease-related anemia
- Hemodialysis-related anemia
- The mean of the two most recent Hemoglobin values before randomization was 10.5mg/dL or less
Who cannot join
- RBC transfusion 8 weeks before transfusion
- IV iron transfusion 6 weeks before transfusion
- Known history of myelodysplastic syndrome
- Known history of multiple myeloma
- Known history of hereditary hematologic diseases
- Active bleeding or any cause of anemia unrelated to CKD
Show all 9Show fewer
- NYHA Class III or IV congestive heart failure
- Liver disease, defined as ALT or AST 3x ULN or greater, or total bilirubin 1.5x ULN or greater
- Prior organ transplant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Roxadustat Versus Darbepoetin Alfa on Iron Repletion Effects in the Management of Anemia in Hemodialysis Patients
The goal of this prospective cohort clinical trial is to compare the effects of roxadustat and darbepoetin alfa on hematological and iron-related parameters in adults with end-stage kidney disease (ESKD) receiving maintenance hemodialysis who have erythropoietin-resistant anemia.
The main questions it aims to answer are:
Read more
- Do hematological and iron-related parameters change following treatment with roxadustat or darbepoetin alfa?
- Are there differences in treatment response between roxadustat and darbepoetin alfa?
Researchers will compare oral roxadustat with subcutaneous darbepoetin alfa to evaluate changes in hematological and iron-related parameters over 12 weeks.
Researchers investigate patients who:
- Receive either roxadustat 70 mg orally three times weekly or darbepoetin alfa subcutaneously according to one of two permitted weight-based dosing regimens.
- Undergo laboratory assessments at baseline and after 12 weeks of treatment, including hemoglobin, red blood cell indices, and iron-related parameters.
Read the detailed description
This prospective cohort study will compare the effects of roxadustat and darbepoetin alfa on hematological and iron-related parameters in adults with erythropoietin-resistant anemia receiving maintenance hemodialysis. Patients will receive roxadustat 70 mg three times weekly or darbepoetin alfa, according to hospital protocol, and will be followed for 12 weeks. Hematological and iron-related parameters will be assessed at baseline and 12 weeks, with within-group changes and exploratory between-group differences evaluated.
- Conditions
- CKD Anemia, CKD Anemia in Stable Dialysis Patients
- Being tested
- Roxadustat, Darbepoetin Alfa Injection
- Keywords
- roxadustat, anemia, CKD-related Anemia, Darbepoeitin Alpha
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoxadustatDrug
oral hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs)
Darbepoetin Alfa InjectionDrug
Traditional injectable darbepoetin alfa
| Study group | Role | What they receive |
|---|---|---|
| Darbepoeitin Alpha | Patients are treated with the traditional injectable darbepoetin alfa Receives: Drug: Darbepoetin Alfa Injection | |
| Roxadustat | Patients are treated with the oral hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) Receives: Drug: Roxadustat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Iron profile
The study aims to assess whether Roxadustat usage in the management of CKD-related anemia results in improving iron profile and reducing iron needs compared with traditional treatment for CKD-related anemia.
Measured: 12 weeks
Secondary outcomes (1)
Change in hemoglobin levels
Hemoglobin levels are measured at baseline and at the end of the 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start15 Apr 2026
- Primary completion12 Sep 2026
- Study completion10 Oct 2026
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 CKD AnemiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Misr International University, October 6 University, Egyptian Chinese University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517744
- Sponsor's protocol ID
- 9-2025/18
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Batchelor EK, Kapitsinou P, Pergola PE, Kovesdy CP, Jalal DI. Iron Deficiency in Chronic Kidney Disease: Updates on Pathophysiology, Diagnosis, and Treatment. J Am Soc Nephrol. 2020 Mar;31(3):456-468. doi: 10.1681/ASN.2019020213. Epub 2020 Feb 10.
PubMed 32041774Stoumpos S, Crowe K, Sarafidis P, Barratt J, Bolignano D, Del Vecchio L, Malyszko J, Wiecek A, Ortiz A, Cozzolino M. Hypoxia-inducible factor prolyl hydroxylase inhibitors for anaemia in chronic kidney disease: a clinical practice document by the European Renal Best Practice board of the European Renal Association. Nephrol Dial Transplant. 2024 Sep 27;39(10):1710-1730. doi: 10.1093/ndt/gfae075.
PubMed 38573822
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Roxadustat Versus Darbepoetin Alfa on Iron Repletion Effects in the Management of Anemia in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07517744
- Acronym / sponsor ID
- 9-2025/18
- Conditions
- CKD Anemia, CKD Anemia in Stable Dialysis Patients
- Keywords
- roxadustat, anemia, CKD-related Anemia, Darbepoeitin Alpha
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Misr International University, October 6 University, Egyptian Chinese University
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 12 Sep 2026 (actual)
- Study completion
- 10 Oct 2026 (actual)
- First posted
- 8 Apr 2026 (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.
The goal of this prospective cohort clinical trial is to compare the effects of roxadustat and darbepoetin alfa on hematological and iron-related parameters in adults with end-stage kidney disease (ESKD) receiving maintenance hemodialysis who have erythropoietin-resistant anemia.
The main questions it aims to answer are:
- Do hematological and iron-related parameters change following treatment with roxadustat or darbepoetin alfa?
- Are there differences in treatment response between roxadustat and darbepoetin alfa?
Researchers will compare oral roxadustat with subcutaneous darbepoetin alfa to evaluate changes in hematological and iron-related parameters over 12 weeks.
Researchers investigate patients who:
- Receive either roxadustat 70 mg orally three times weekly or darbepoetin alfa subcutaneously according to one of two permitted weight-based dosing regimens.
- Undergo laboratory assessments at baseline and after 12 weeks of treatment, including hemoglobin, red blood cell indices, and iron-related parameters.
Detailed description
This prospective cohort study will compare the effects of roxadustat and darbepoetin alfa on hematological and iron-related parameters in adults with erythropoietin-resistant anemia receiving maintenance hemodialysis. Patients will receive roxadustat 70 mg three times weekly or darbepoetin alfa, according to hospital protocol, and will be followed for 12 weeks. Hematological and iron-related parameters will be assessed at baseline and 12 weeks, with within-group changes and exploratory between-group differences evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Darbepoeitin Alpha | – | Drug: Darbepoetin Alfa InjectionPatients are treated with the traditional injectable darbepoetin alfa |
| Roxadustat | – | Drug: RoxadustatPatients are treated with the oral hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Egyptian patients with ESKD- or HD-related anemia who follow up at the Electricity hospital.
Key inclusion criteria (3 listed)
- End-stage kidney disease-related anemia
- Hemodialysis-related anemia
- The mean of the two most recent Hemoglobin values before randomization was 10.5mg/dL or less
Key exclusion criteria (9 listed)
- RBC transfusion 8 weeks before transfusion
- IV iron transfusion 6 weeks before transfusion
- Known history of myelodysplastic syndrome
- Known history of multiple myeloma
- Known history of hereditary hematologic diseases
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 |
|---|---|---|
| Roxadustatoral hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) | Drug | Roxadustat |
| Darbepoetin Alfa InjectionTraditional injectable darbepoetin alfa | Drug | Darbepoeitin Alpha |
Primary outcome
Change in Iron profile
Time frame: 12 weeks
The study aims to assess whether Roxadustat usage in the management of CKD-related anemia results in improving iron profile and reducing iron needs compared with traditional treatment for CKD-related anemia.
1 secondary outcome
Change in hemoglobin levels
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 32041774Batchelor EK, Kapitsinou P, Pergola PE, Kovesdy CP, Jalal DI. Iron Deficiency in Chronic Kidney Disease: Updates on Pathophysiology, Diagnosis, and Treatment. J Am Soc Nephrol. 2020 Mar;31(3):456-468. doi: 10.1681/ASN.2019020213. Epub 2020 Feb 10.
- Background: PubMed 38573822Stoumpos S, Crowe K, Sarafidis P, Barratt J, Bolignano D, Del Vecchio L, Malyszko J, Wiecek A, Ortiz A, Cozzolino M. Hypoxia-inducible factor prolyl hydroxylase inhibitors for anaemia in chronic kidney disease: a clinical practice document by the European Renal Best Practice board of the European Renal Association. Nephrol Dial Transplant. 2024 Sep 27;39(10):1710-1730. doi: 10.1093/ndt/gfae075.
- KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney DiseaseLink provided by the sponsor.
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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?
An observational study of CKD Anemia and CKD Anemia in Stable Dialysis Patients, run by Ain Shams University at 1 site in Egypt.
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 3 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: finished, as of the sponsor's last update on 28 Oct 2026. 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 Egypt. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Iron profile (time frame: 12 weeks). 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 NCT07517744, 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 28 Oct 2026.