NCT07855458

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Oct 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

October 2, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

12 months

First QC Date

September 28, 2026

Last Update Submit

September 28, 2026

Conditions

Chronic Kidney Disease (CKD)Hemodialysis ComplicationAnemia

Keywords

HemodialysisESA hyporesponsivenessErythropoietin resistance indexAnemiaAssiut

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (6)

  • Proportion of patients with persistent ESA hyporesponsiveness

    12 months

  • Proportion of patients who recover from ESA hyporesponsiveness

    12 months

  • Mean erythropoietin resistance index

    Baseline and at 12 months

  • Mean serum ferritin

    Baseline and at 12 months

  • Mean serum albumin

    Baseline and at 12 months

  • +1 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with end-stage renal disease receiving maintenance hemodialysis at the Hemodialysis Center, Assiut University Hospital.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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: 35462377RESULT

  • 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: 21325348RESULT

  • 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: 19339087RESULT

MeSH Terms

Conditions

Renal Insufficiency, ChronicAnemia

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Marwa k Abdo, prof

    Internal Medicine Department, Assiut University Hospitals

    STUDY CHAIR

Central Study Contacts

Hamid I Hamid, Resident

CONTACT

+201122287965hamidebrheem@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician, Department of Internal Medicine

Study Record Dates

First Submitted

September 28, 2026

First Posted

October 2, 2026

Study Start

October 2, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

October 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share