Anemia in Dialysis-dependent CKD PatientsPhase 4NCT06115421
Effect of Low Doses of Hypoxia-inducible Factor- Prolyl Hydroxylase Enzyme Inhibitor Plus Iron in the Treatment of Anemia in Dialysis-dependent Chronic Kidney Disease Patients
A Phase 4 study testing Roxadustat in people with Anemia in Dialysis-dependent CKD Patients, run by Alexandria University at 1 site in Egypt.
Trial summary
this study aims to : 1. To compare the efficacy of combining low doses of Roxadustat Hypoxia-Inducible Factor (HIF)-Prolyl Hydroxylase (PHD) inhibitor and iron versus standard treatment with erythropoietin-stimulating agents (ESA) in the treatment of anemia as a complication of chronic kidney disease (CKD) among… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anemia in Dialysis-dependent CKD Patients
- What is being tested?
- Roxadustat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 24 May 2023to 30 Jan 2025
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Ages >18. 2. End Stage Renal Disease (ESRD) on Incident Dialysis (ID), defined as dialysis ≥2 weeks but ≤4 months or stable dialysis (dialysis dependent DD) defined as dialysis for ≥ 4 months \&having hemodialysis access.
- 3. Hb ≤10.5 g/dl during the screening period. 4. Erythropoiesis-stimulating agents (ESAs) naïve patients, ESAs resistant patients, or patients who didn't receive any ESA treatment within 4-6 weeks
Who cannot join
- 1. Age <18 year or >80 year 2. Known hypersensitivity to active substances, peanuts, soya, or any of the drug excipients.
- 3. History of hereditary problems galactose intolerance 4. Systolic BP ≥160 mmHg or diastolic BP ≥95 mmHg, within 2 weeks prior to randomization. Patients may be reevaluated once BP is controlled.
- 5. Congestive heart failure (CHF), New York Heart Association (NYHA) Class III or IV 6. Acute coronary syndrome (ACS), a thrombotic/thromboembolic event (eg, deep vein thrombosis (DVT) or pulmonary embolism (PE)), stroke, or seizure, within 12 weeks prior to randomization.
- 7. Elective coronary revascularization or elective surgery that is expected to lead to significant blood loss.
- 8. Hematologic diseases such as thalassemia, sickle cell anemia, active inflammatory bowel disease, active or chronic gastrointestinal bleeding, significant blood loss, or any other known causes for anemia other than CKD.
- 9. Red blood cell transfusion within 6 weeks prior to the first screening visit.
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- 10. More than one dose of IV iron was received within 12 weeks prior to recruiting.
- 11. History of uncontrolled chronic, severe, fulminant, autoimmune, or end-stage liver disease with Aspartate aminotransferase( AST), alanine aminotransferase (ALT) > 3 × upper limit normal (ULN), or total bilirubin > 1.5 × ULN. 12. Any clinically significant inflammatory disorders other than CKD, as any evidence of an active underlying infection, rheumatoid arthritis, systemic lupus, or cancer.
- 13. Known and untreated retinal vein occlusion or proliferative diabetic retinopathy, macular degeneration, diabetic macular edema.
- 14. Prior organ transplant or a scheduled organ transplantation date. 15. Planning for pregnancy, pregnant, or breastfeeding female patients
Trial locations and contacts
1 site in 1 country.
About this study
this study aims to :
- To compare the efficacy of combining low doses of Roxadustat Hypoxia-Inducible Factor (HIF)-Prolyl Hydroxylase (PHD) inhibitor and iron versus standard treatment with erythropoietin-stimulating agents (ESA) in the treatment of anemia as a complication of chronic kidney disease (CKD) among dialysis-dependent patients.
- To emphasize the safety profile of low doses of Roxadustat HIF-PHD.
- To assess changes in the quality of life of patients with kidney disease before and after treatment.
Read the detailed description
1- The Ethics Committee of Alexandria University approved conducting the research in April 2023.
- Informed consent will be obtained from all patients to participate in the trial after a thorough explanation of the nature of the study 3. Dialysis-dependent CKD patients with anemia will be recruited from Alexandria University Hospital \&/or private hospitals (if any).
- Study design: two-arm open-label non randomized active control study 5. Sample size was calculated using G*Power 3, a minimal total hypothesized sample size of 72 eligible adult Dialysis dependent CKD patients (DD -CKD) with anemia [ 36 per group] is needed; taking into consideration 95% confidence level, the effect size of 0.6. and 80% power using a t-test.
- Three phases will comprise the trial: a screening phase that lasts from 2-4 weeks, a therapy phase that lasts for up to 12 weeks, and a follow-up phase that lasts 2-4 weeks. After obtaining informed consent, during visit 1, we will check the inclusion and exclusion criteria At each visit, the patient's well-being and the occurrence of any Drug-Related Adverse effects (DRAs) will be monitored accurately.
- The Arabic-translated reliable and valid version of the Kidney Disease Quality of Life questionnaire (KDQOL-36) for patients with CKD will be completed with patients during the interview at the baseline and after fulfilling the whole study period 8. The collected data will be subjected to statistical analysis by the use of suitable techniques to achieve the objectives of the study
- Being tested
- Roxadustat
- Keywords
- Dialysis-dependent CKD patients ,anemia ,hypoxia-inducible factor-, Roxadustatse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoxadustatDrug
Also called hypoxia-inducible factor- prolyl hydroxylase enzyme inhibitor
hypoxia-inducible factor-prolyl hydroxylase inhibitors (HIF-PHIs)
| Study group | Role | What they receive |
|---|---|---|
| oral low doses of Roxadustat three times weekly plus iron supplement, | Experimental | Not described Receives: Drug: Roxadustat |
| Erythropoiesis-stimulating agents (ESAs) | Active comparator | Not described Receives: Drug: Roxadustat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in hemoglobin level from baseline
HB g/dl
Measured: 3 months
Iron metabolism parameters change from the baseline
serum iron µg/ml , ferritin µg/l, Total Iron Binding Capacity µg/ml (TIBC) levels, and transferrin saturation (TSAT)%
Measured: 3 months
Safety profile
adverse events will be reported using a pre-prepared checklist
Measured: 3 months
Secondary outcomes (5)
Time to achieve and maintain HB target
desired level (HB) 10-12 g/dL
Measured: 3 months
The need for rescue therapy
- For the Roxadustat-treated participants (intervention arm) rescue therapy is defined as, red blood cell (RBC) transfusion or erythropoiesis-stimulating agent (ESA).
- For erythropoiesis-stimulating agents (ESA) (control arm) rescue therapy is defined as RBC transfusion
Measured: 3 months
The minimum effective dose in combination with iron is needed to achieve the HB target.
Measured: 3 months
Change in hepcidin level in the intervention group
Measured: 3 months
Change in the Quality of Life (QoL) of the patients after the completion of the study period
Arabic-translated reliable and valid version of the Kidney Disease Quality of Life questionnaire (KDQOL-36) for patients with CKD
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start24 May 2023
- Primary completion30 Aug 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia in Dialysis-dependent CKD PatientsStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two-arm open-label randomized active control study
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115421
- Sponsor's protocol ID
- 0201793
- Status last verified
- Feb 2025
- First submitted
- 15 Oct 2023
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Doses of Hypoxia-inducible Factor- Prolyl Hydroxylase Enzyme Inhibitor Plus Iron in the Treatment of Anemia in Dialysis-dependent Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT06115421
- Acronym / sponsor ID
- 0201793
- Keywords
- Dialysis-dependent CKD patients ,anemia ,hypoxia-inducible factor-, Roxadustatse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 3 Nov 2023 (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 study aims to :
- To compare the efficacy of combining low doses of Roxadustat Hypoxia-Inducible Factor (HIF)-Prolyl Hydroxylase (PHD) inhibitor and iron versus standard treatment with erythropoietin-stimulating agents (ESA) in the treatment of anemia as a complication of chronic kidney disease (CKD) among dialysis-dependent patients.
- To emphasize the safety profile of low doses of Roxadustat HIF-PHD.
- To assess changes in the quality of life of patients with kidney disease before and after treatment.
Detailed description
1- The Ethics Committee of Alexandria University approved conducting the research in April 2023.
- Informed consent will be obtained from all patients to participate in the trial after a thorough explanation of the nature of the study 3. Dialysis-dependent CKD patients with anemia will be recruited from Alexandria University Hospital \&/or private hospitals (if any).
- Study design: two-arm open-label non randomized active control study 5. Sample size was calculated using G*Power 3, a minimal total hypothesized sample size of 72 eligible adult Dialysis dependent CKD patients (DD -CKD) with anemia [ 36 per group] is needed; taking into consideration 95% confidence level, the effect size of 0.6. and 80% power using a t-test.
- Three phases will comprise the trial: a screening phase that lasts from 2-4 weeks, a therapy phase that lasts for up to 12 weeks, and a follow-up phase that lasts 2-4 weeks. After obtaining informed consent, during visit 1, we will check the inclusion and exclusion criteria At each visit, the patient's well-being and the occurrence of any Drug-Related Adverse effects (DRAs) will be monitored accurately.
- The Arabic-translated reliable and valid version of the Kidney Disease Quality of Life questionnaire (KDQOL-36) for patients with CKD will be completed with patients during the interview at the baseline and after fulfilling the whole study period 8. The collected data will be subjected to statistical analysis by the use of suitable techniques to achieve the objectives of the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two-arm open-label randomized active control study
| Arm | Type | Receives |
|---|---|---|
| oral low doses of Roxadustat three times weekly plus iron supplement, | Experimental | Drug: Roxadustat |
| Erythropoiesis-stimulating agents (ESAs) | Active comparator | Drug: Roxadustat |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Ages >18. 2. End Stage Renal Disease (ESRD) on Incident Dialysis (ID), defined as dialysis ≥2 weeks but ≤4 months or stable dialysis (dialysis dependent DD) defined as dialysis for ≥ 4 months \&having hemodialysis access.
- 3. Hb ≤10.5 g/dl during the screening period. 4. Erythropoiesis-stimulating agents (ESAs) naïve patients, ESAs resistant patients, or patients who didn't receive any ESA treatment within 4-6 weeks
Key exclusion criteria (10 listed)
- 1. Age <18 year or >80 year 2. Known hypersensitivity to active substances, peanuts, soya, or any of the drug excipients.
- 3. History of hereditary problems galactose intolerance 4. Systolic BP ≥160 mmHg or diastolic BP ≥95 mmHg, within 2 weeks prior to randomization. Patients may be reevaluated once BP is controlled.
- 5. Congestive heart failure (CHF), New York Heart Association (NYHA) Class III or IV 6. Acute coronary syndrome (ACS), a thrombotic/thromboembolic event (eg, deep vein thrombosis (DVT) or pulmonary embolism (PE)), stroke, or seizure, within 12 weeks prior to randomization.
- 7. Elective coronary revascularization or elective surgery that is expected to lead to significant blood loss.
- 8. Hematologic diseases such as thalassemia, sickle cell anemia, active inflammatory bowel disease, active or chronic gastrointestinal bleeding, significant blood loss, or any other known causes for anemia other than CKD.
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 |
|---|---|---|
| RoxadustatAlso: hypoxia-inducible factor- prolyl hydroxylase enzyme inhibitorhypoxia-inducible factor-prolyl hydroxylase inhibitors (HIF-PHIs) | Drug | Erythropoiesis-stimulating agents (ESAs), oral low doses of Roxadustat three times weekly plus iron supplement, |
Primary outcome
Changes in hemoglobin level from baseline
Time frame: 3 months
HB g/dl
Iron metabolism parameters change from the baseline
Time frame: 3 months
serum iron µg/ml , ferritin µg/l, Total Iron Binding Capacity µg/ml (TIBC) levels, and transferrin saturation (TSAT)%
Safety profile
Time frame: 3 months
adverse events will be reported using a pre-prepared checklist
5 secondary outcomes
Time to achieve and maintain HB target
Time frame: 3 months
The need for rescue therapy
Time frame: 3 months
The minimum effective dose in combination with iron is needed to achieve the HB target.
Time frame: 3 months
Change in hepcidin level in the intervention group
Time frame: 3 months
Change in the Quality of Life (QoL) of the patients after the completion of the study period
Time frame: 3 months
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 24 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Anemia in Dialysis-dependent CKD Patients
RecruitingPhase 3
A Study of AND017 to Evaluate Efficacy and Safety in Patients With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)
Anemia Due to Chronic Kidney Disease
RecruitingPhase 3
A Study of AND017 to Evaluate Efficacy and Safety in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia
Anemia Due to Chronic Kidney Disease
RecruitingPhase 4
Correction of Anemia With Enarodustat in Non-dialysis Dependent Chronic Kidney Disease
Chronic Kidney Disease Associated Anemia
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 Roxadustat in people with Anemia in Dialysis-dependent CKD Patients, run by Alexandria 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 2 inclusion and 10 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 24 Jun 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.
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?
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?
Changes in hemoglobin level from baseline (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2026.