Anemia in End Stage Renal DiseasePhase 1NCT06996717
Study of Rule-Based Algorithms in Anemia Management in Prevalent Hemodialysis Patients and Its Relation to Patients' Outcomes
A Phase 1 study testing ESA in people with Anemia in End Stage Renal Disease, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study will assess role of rule based algorithm in anemia management in hemodialysis patients and its relation to patient's mortality Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia in End Stage Renal Disease
- What is being tested?
- ESA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 30 Jun 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- patients on hemodialysis for more than six months patients undergoing hemodialysis three times per week each session for 4 hours patients with urea reduction ratio>65% patients with transferrin saturation>20%
Who cannot join
- patients with terminal illness or malignancy patients receiving hemodialysis from catheter or arteriovenous graft
Trial locations and contacts
1 site in 1 country.
About this study
The study will assess role of rule based algorithm in anemia management in hemodialysis patients and its relation to patient's mortality
- Conditions
- Anemia in End Stage Renal Disease
- Being tested
- ESA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESADrug
anemia management algorithm will successfully increase the number of patients in the target hemoglobin range
| Study group | Role | What they receive |
|---|---|---|
| end stage renal disease patients | Experimental | management of different hemoglobin levels by erythropoietin stimulating agents according to expert opinion and according to algorithm Receives: Drug: ESA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase the number of patients in the target Hb range
This study will achieve better dosing of erythropoietin stimulating agents using rule based algorithms to correct anemia and avoid unnecessary extra doses of erythropoietin stimulating agents with their side effects
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 Jan 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia in End Stage Renal DiseaseStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996717
- Sponsor's protocol ID
- MS 7/2024/2025
- Status last verified
- Jan 2025
- First submitted
- 6 May 2025
- Last updated
- 30 May 2025
- 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 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Rule-Based Algorithms in Anemia Management in Prevalent Hemodialysis Patients and Its Relation to Patients' Outcomes
- ClinicalTrials.gov ID
- NCT06996717
- Acronym / sponsor ID
- MS 7/2024/2025
- Conditions
- Anemia in End Stage Renal Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 30 May 2025 (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 study will assess role of rule based algorithm in anemia management in hemodialysis patients and its relation to patient's mortality
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| end stage renal disease patients | Experimental | Drug: ESAmanagement of different hemoglobin levels by erythropoietin stimulating agents according to expert opinion and according to algorithm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients on hemodialysis for more than six months patients undergoing hemodialysis three times per week each session for 4 hours patients with urea reduction ratio>65% patients with transferrin saturation>20%
Key exclusion criteria (1 listed)
- patients with terminal illness or malignancy patients receiving hemodialysis from catheter or arteriovenous graft
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 |
|---|---|---|
| ESAanemia management algorithm will successfully increase the number of patients in the target hemoglobin range | Drug | end stage renal disease patients |
Primary outcome
Increase the number of patients in the target Hb range
Time frame: 6 months
This study will achieve better dosing of erythropoietin stimulating agents using rule based algorithms to correct anemia and avoid unnecessary extra doses of erythropoietin stimulating agents with their side effects
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
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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?
A Phase 1 study testing ESA in people with Anemia in End Stage Renal Disease, 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 30 May 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Increase the number of patients in the target Hb range (time frame: 6 months). 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 30 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.