Chronic Kidney Disease (CKD)NCT07855458
ESA Hyporesponsiveness in Hemodialysis Patients
An observational study of Chronic Kidney Disease (CKD) and Hemodialysis Complication, run by Assiut University.
Trial summary
This prospective cohort study aims to evaluate the development, persistence, and recovery of erythropoiesis-stimulating agent (ESA) hyporesponsiveness among patients receiving maintenance hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease (CKD), Hemodialysis Complication, Anemia
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 2 Oct 2026to 1 Mar 2028
- Phase
- Observational
- 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
Study population: Adult patients with end-stage renal disease receiving maintenance hemodialysis at the Hemodialysis Center, Assiut University Hospital.
Who may be able to join
- Age ≥18 years.
- ESRD/CKD G5D receiving maintenance hemodialysis.
- Hemodialysis ≥3 months before enrollment.
- Receiving ESA therapy for anemia.
- Expected to remain on hemodialysis during the study period.
- Baseline Hb and ESA dose available.
Who cannot join
- Active malignancy.
- Hematological malignancy.
- Known hemoglobinopathy causing anemia.
- Recent blood transfusion, e.g. within 3 months before enrollment.
- Recent major surgery.
- Active major bleeding.
Show all 10Show fewer
- Pregnancy.
- Recent kidney transplantation.
- Known pure red-cell aplasia.
- Incomplete clinical or laboratory follow-up
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Predictors of Development and Persistence of Erythropoietin-Stimulating Agents Hyporesponsiveness in Hemodialysis Patients
This prospective cohort study aims to evaluate the development, persistence, and recovery of erythropoiesis-stimulating agent (ESA) hyporesponsiveness among patients receiving maintenance hemodialysis.
Read the detailed description
Anemia is a common complication in patients receiving maintenance hemodialysis. Response to erythropoiesis-stimulating agents varies, and some patients develop hyporesponsiveness.
This observational study will include adult patients on maintenance hemodialysis who are receiving ESA therapy. The erythropoietin resistance index (ERI) will be calculated at baseline and during 12 months of follow-up to identify development, persistence, and recovery of ESA hyporesponsiveness.
- Keywords
- Hemodialysis, ESA hyporesponsiveness, Erythropoietin resistance index, Anemia, Assiut
- Medical subject headings
- Renal Insufficiency, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single cohort: Maintenance Hemodialysis Patients | Adult patients receiving maintenance hemodialysis and ESA therapy who will be followed for 12 months to assess development, persistence, and recovery of ESA hyporesponsiveness. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new-onset ESA hyporesponsiveness
Proportion of patients who develop new-onset ESA hyporesponsiveness, defined as erythropoietin resistance index (ERI) > 15.4 during the 12-month follow-up.
Measured: 12 months
Secondary outcomes (6)
Proportion of patients with persistent ESA hyporesponsiveness
Proportion of patients with ESA hyporesponsiveness (ERI > 15.4) persisting for more than 4 months.
Measured: 12 months
Proportion of patients who recover from ESA hyporesponsiveness
Proportion of patients who recover from ESA hyporesponsiveness (ERI ≤ 15.4) during follow-up.
Measured: 12 months
Mean erythropoietin resistance index
Mean erythropoietin resistance index (ERI) calculated as weekly ESA dose (IU/week) / [body weight (kg) × hemoglobin (g/dL)].
Measured: Baseline and at 12 months
Mean serum ferritin
Mean serum ferritin level in ng/mL.
Measured: Baseline and at 12 months
Mean serum albumin
Mean serum albumin level in g/dL.
Measured: Baseline and at 12 months
Mean C-reactive protein
Mean C-reactive protein (CRP) level in mg/L.
Measured: Baseline and at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start2 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease (CKD)Studies of the same condition, open and under way.
- More trials run by Assiut 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamid Ibrahim Hamid, Assiut University
- Investigators
- Marwa k Abdo, prof, Study chair, Internal Medicine Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855458
- Sponsor's protocol ID
- ESA-Hyporesponse-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goodkin DA, Zhao J, Cases A, Nangaku M, Karaboyas A. Resistance to Erythropoiesis-Stimulating Agents among Patients on Hemodialysis Is Typically Transient. Am J Nephrol. 2022;53(5):333-342. doi: 10.1159/000523947. Epub 2022 Apr 22.
PubMed 35462377Panichi V, Rosati A, Bigazzi R, Paoletti S, Mantuano E, Beati S, Marchetti V, Bernabini G, Grazi G, Rizza GM, Migliori M, Giusti R, Lippi A, Casani A, Barsotti G, Tetta C; RISCAVID Study Group. Anaemia and resistance to erythropoiesis-stimulating agents as prognostic factors in haemodialysis patients: results from the RISCAVID study. Nephrol Dial Transplant. 2011 Aug;26(8):2641-8. doi: 10.1093/ndt/gfq802. Epub 2011 Feb 16.
PubMed 21325348Kalantar-Zadeh K, Lee GH, Miller JE, Streja E, Jing J, Robertson JA, Kovesdy CP. Predictors of hyporesponsiveness to erythropoiesis-stimulating agents in hemodialysis patients. Am J Kidney Dis. 2009 May;53(5):823-34. doi: 10.1053/j.ajkd.2008.12.040. Epub 2009 Apr 1.
PubMed 19339087
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Development and Persistence of Erythropoietin-Stimulating Agents Hyporesponsiveness in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07855458
- Acronym / sponsor ID
- ESA-Hyporesponse-Assiut-2026
- Keywords
- Hemodialysis, ESA hyporesponsiveness, Erythropoietin resistance index, Anemia, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 2 Oct 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.
This prospective cohort study aims to evaluate the development, persistence, and recovery of erythropoiesis-stimulating agent (ESA) hyporesponsiveness among patients receiving maintenance hemodialysis.
Detailed description
Anemia is a common complication in patients receiving maintenance hemodialysis. Response to erythropoiesis-stimulating agents varies, and some patients develop hyporesponsiveness.
This observational study will include adult patients on maintenance hemodialysis who are receiving ESA therapy. The erythropoietin resistance index (ERI) will be calculated at baseline and during 12 months of follow-up to identify development, persistence, and recovery of ESA hyporesponsiveness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort: Maintenance Hemodialysis Patients | – | –Adult patients receiving maintenance hemodialysis and ESA therapy who will be followed for 12 months to assess development, persistence, and recovery of ESA hyporesponsiveness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with end-stage renal disease receiving maintenance hemodialysis at the Hemodialysis Center, Assiut University Hospital.
Key inclusion criteria (6 listed)
- Age ≥18 years.
- ESRD/CKD G5D receiving maintenance hemodialysis.
- Hemodialysis ≥3 months before enrollment.
- Receiving ESA therapy for anemia.
- Expected to remain on hemodialysis during the study period.
Key exclusion criteria (10 listed)
- Active malignancy.
- Hematological malignancy.
- Known hemoglobinopathy causing anemia.
- Recent blood transfusion, e.g. within 3 months before enrollment.
- Recent major surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of new-onset ESA hyporesponsiveness
Time frame: 12 months
Proportion of patients who develop new-onset ESA hyporesponsiveness, defined as erythropoietin resistance index (ERI) > 15.4 during the 12-month follow-up.
6 secondary outcomes
Proportion of patients with persistent ESA hyporesponsiveness
Time frame: 12 months
Proportion of patients who recover from ESA hyporesponsiveness
Time frame: 12 months
Mean erythropoietin resistance index
Time frame: Baseline and at 12 months
Mean serum ferritin
Time frame: Baseline and at 12 months
Mean serum albumin
Time frame: Baseline and at 12 months
Mean C-reactive protein
Time frame: Baseline and at 12 months
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 2 Oct 2026.
- Results publication: PubMed 35462377Goodkin DA, Zhao J, Cases A, Nangaku M, Karaboyas A. Resistance to Erythropoiesis-Stimulating Agents among Patients on Hemodialysis Is Typically Transient. Am J Nephrol. 2022;53(5):333-342. doi: 10.1159/000523947. Epub 2022 Apr 22.
- Results publication: PubMed 21325348Panichi V, Rosati A, Bigazzi R, Paoletti S, Mantuano E, Beati S, Marchetti V, Bernabini G, Grazi G, Rizza GM, Migliori M, Giusti R, Lippi A, Casani A, Barsotti G, Tetta C; RISCAVID Study Group. Anaemia and resistance to erythropoiesis-stimulating agents as prognostic factors in haemodialysis patients: results from the RISCAVID study. Nephrol Dial Transplant. 2011 Aug;26(8):2641-8. doi: 10.1093/ndt/gfq802. Epub 2011 Feb 16.
- Results publication: PubMed 19339087Kalantar-Zadeh K, Lee GH, Miller JE, Streja E, Jing J, Robertson JA, Kovesdy CP. Predictors of hyporesponsiveness to erythropoiesis-stimulating agents in hemodialysis patients. Am J Kidney Dis. 2009 May;53(5):823-34. doi: 10.1053/j.ajkd.2008.12.040. Epub 2009 Apr 1.
- 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.
Marwa k Abdo, prof study chair
Internal Medicine Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease (CKD) and Hemodialysis Complication, run by Assiut University.
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 6 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: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Contact Hamid I Hamid, Resident (+201122287965, hamidebrheem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of new-onset ESA hyporesponsiveness (time frame: 12 months). 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 NCT07855458, which also lists 3 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 2 Oct 2026.