ESA Hyporesponsiveness in Hemodialysis Patients

NCT07855458 — Not yet recruiting, 200 participants, Assiut University
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Predictors of Development and Persistence of Erythropoietin-Stimulating Agents Hyporesponsiveness in Hemodialysis Patients

RegistryNCT07855458
StatusNot yet recruiting
Study typeObservational
Enrollment200 (Estimated)
SponsorAssiut University (Other)
ConditionsChronic Kidney Disease (CKD), Hemodialysis Complication, Anemia
Datesstart 2026-10-02 (estimated), primary completion 2027-10-01 (estimated), completion 2028-03-01 (estimated), first posted 2026-10-02, last updated 2026-10-02

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-Summary

This prospective cohort study aims to evaluate the development, persistence, and recovery of erythropoiesis-stimulating agent (ESA) hyporesponsiveness among patients receiving maintenance hemodialysis.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Single cohort: Maintenance Hemodialysis PatientsAdult patients receiving maintenance hemodialysis and ESA therapy who will be followed for 12 months to assess development, persistence, and recovery of ESA hyporesponsiveness.

+Outcome measures

Primary outcomes

  • Incidence of new-onset ESA hyporesponsiveness [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.

Secondary outcomes

  • Proportion of patients with persistent ESA hyporesponsiveness [12 months]: Proportion of patients with ESA hyporesponsiveness (ERI > 15.4) persisting for more than 4 months.
  • Proportion of patients who recover from ESA hyporesponsiveness [12 months]: Proportion of patients who recover from ESA hyporesponsiveness (ERI ≤ 15.4) during follow-up.
  • Mean erythropoietin resistance index [Baseline and at 12 months]: Mean erythropoietin resistance index (ERI) calculated as weekly ESA dose (IU/week) / \[body weight (kg) × hemoglobin (g/dL)\].
  • Mean serum ferritin [Baseline and at 12 months]: Mean serum ferritin level in ng/mL.
  • Mean serum albumin [Baseline and at 12 months]: Mean serum albumin level in g/dL.
  • Mean C-reactive protein [Baseline and at 12 months]: Mean C-reactive protein (CRP) level in mg/L.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Active malignancy.
* Hematological malignancy.
* Known hemoglobinopathy causing anemia.
* Recent blood transfusion, e.g. within 3 months before enrollment.
* Recent major surgery.
* Active major bleeding.
* Pregnancy.
* Recent kidney transplantation.
* Known pure red-cell aplasia.
* Incomplete clinical or laboratory follow-up

+Publications

  • Results publication: 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. PMID 35462377
  • Results publication: Panichi 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. PMID 21325348
  • Results publication: Kalantar-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. PMID 19339087

+Investigators

  • Marwa k Abdo, prof, Study chair, Internal Medicine Department, Assiut University Hospitals