Eprex (epoetin alfa) / J&J - LARVOL DELTA

A Trial Comparing Three Different Treatment Options for Adults With Low-Risk Myelodysplasia and Anemia (A MyeloMATCH Treatment Trial) (clinicaltrials.gov) - P2 | N=270 | Not yet recruiting | Sponsor: National Cancer Institute (NCI)

New P2 trial • Anemia • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Myelodysplastic Syndrome • Oncology

Audit to investigate haemoglobin levels following switch of ESA brand for haemodialysis patients. (UKKW 2026) - "Erythropoietin stimulating agents (ESAs) such as Eprex (epoetin alfa) are used to manage haemoglobin (Hb) anaemia of CKD. Overall, it is evident that the switch from Eprex to Retacrit was a success in the Trust as patient safety wasn't compromised. This audit should provide further evidence to wider Trusts to consider ESA alternatives as a cost-savings strategy and potentially improve clinical outcomes for haemodialysis on ESAs as demonstrated in this cohort."

Clinical • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

EPO-PRETAR: A Trial Testing Early Vs Late Onset of EPO Alfa Treatment in Lower Risk MDS (clinicaltrials.gov) - P3 | N=124 | Recruiting | Sponsor: Groupe Francophone des Myelodysplasies | Not yet recruiting ➔ Recruiting

Enrollment open • Anemia • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

EPO-PRETAR: A Trial Testing Early Vs Late Onset of EPO Alfa Treatment in Lower Risk MDS (clinicaltrials.gov) - P3 | N=124 | Not yet recruiting | Sponsor: Groupe Francophone des Myelodysplasies

New P3 trial • Anemia • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

EPO-PRETAR: A Trial Testing Early Vs Late Onset of EPO Alfa Treatment in Lower Risk MDS (clinicaltrials.gov) - P3 | N=124 | Active, not recruiting | Sponsor: Groupe Francophone des Myelodysplasies | Recruiting ➔ Active, not recruiting | Trial completion date: May 2024 ➔ Oct 2028

Enrollment closed • Trial completion date • Anemia • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

EPO-PRETAR: A Trial Testing Early Vs Late Onset of EPO Alfa Treatment in Lower Risk MDS (clinicaltrials.gov) - P3 | N=124 | Recruiting | Sponsor: Groupe Francophone des Myelodysplasies | Trial completion date: Oct 2021 ➔ May 2024 | Trial primary completion date: Oct 2019 ➔ May 2022

Trial completion date • Trial primary completion date • Anemia • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

After Eprex® discontinuation: Multicenter evidence for a biosimilar erythropoietin and health system resilience in Taiwan. (PubMed, J Chin Med Assoc) - No abstract available

Journal

Detection of a Distinct Erythropoietin (EPO) Profile After Isoelectric Focusing in Patients With Familial Erythrocytosis. (PubMed, Drug Test Anal) - "To avoid any possible misinterpretation in an antidoping context, the goal of this work was to characterize urine and blood EPO profiles from these patients using all methods authorized in antidoping laboratories (IEF-PAGE, SDS-PAGE, and SAR-PAGE) and to compare them with wild-type (WT) EPO and with profiles obtained after the administration of rEPO Eprex...However, they did not meet the identification criteria used when this technique was the only authorized method. It is highly unlikely that these EPO mutations, only identified in erythrocytosis patients yet, could lead to an adverse analytical finding."

Journal • Hematological Disorders • EPO

Efficacy, safety, and immunogenicity of UB-851 versus Eprex® in patients with renal anemia receiving hemodialysis: A randomized, double-masked, phase III trial. (PubMed, J Chin Med Assoc) - "UB-851 demonstrated clinical equivalence to epoetin alfa in maintaining Hb levels in patients with anemic CKD undergoing hemodialysis. The safety and immunogenicity profiles were comparable, supporting UB-851 as a biosimilar to epoetin alfa."

Journal • P3 data • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

NCI-2009-01173: Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia (clinicaltrials.gov) - P3 | N=247 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Oct 2025 ➔ Oct 2026

Trial completion date • Anemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

EPO-TRAUMA: ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients (clinicaltrials.gov) - P3 | N=2500 | Recruiting | Sponsor: Australian and New Zealand Intensive Care Research Centre | Trial completion date: Dec 2025 ➔ Aug 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • CNS Disorders • Vascular Neurology

Clinical and laboratory prognostic factors associated with methanol toxicity outcomes in patients at Tabriz Sina Hospital: A retrospective study. (PubMed, Hum Exp Toxicol) - "Bicarbonate, Eprex, and methylprednisolone reduced complications. Time from ingestion to admission (48-72 h) did not affect mortality, but delayed hemodialysis initiation worsened outcomes.ConclusionEarly presentation and providing early therapeutic modalities have a significant impact on the mortality rate and the patients' outcome."

Biomarker • Journal • Retrospective data • Addiction (Opioid and Alcohol) • Cardiovascular

PK, PD, Safety and Immunogenicity Study of Erythropoietin of Incepta Pharmaceuticals Ltd With Eprex (Janssen-Cilag). (clinicaltrials.gov) - P3 | N=56 | Recruiting | Sponsor: Incepta Pharmaceuticals Ltd

New P3 trial

Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA (clinicaltrials.gov) - P1/2 | N=150 | Recruiting | Sponsor: Groupe Francophone des Myelodysplasies | Trial completion date: Nov 2027 ➔ Jun 2029 | Trial primary completion date: May 2027 ➔ Dec 2028

Trial completion date • Trial primary completion date • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

EPO: Pharmacokinetics, Pharmacodynamics, and Safety of Nanokine Produced by Nanogen Pharmaceutical Joint Stock Company (clinicaltrials.gov) - P1 | N=44 | Not yet recruiting | Sponsor: Nanogen Pharmaceutical Biotechnology Joint Stock Company

New P1 trial

Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease (clinicaltrials.gov) - P3 | N=43 | Completed | Sponsor: Bio Sidus SA | Active, not recruiting ➔ Completed | N=120 ➔ 43

Enrollment change • Trial completion • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Early Initiation of ESAs in Low-Risk Anemic MDS Increased HI-E and Duration Without Improving QoL or Survival (Hematology Advisor) - P3 | N=124 | EPO-PRETAR (NCT03223961) | "The early initiation of erythrocyte-stimulating agents (ESAs) in patients with low-risk anemic myelodysplastic syndromes (MDS) increased hematologic improvement-erythroid (HI-E) and its duration, but did not affect quality of life (QoL) or survival, according to a presentation at the ASH Annual Meeting 2024...Park and colleagues reported on a phase III trial, called EPO-PRETAR (ClinicalTrials.gov Identifier: NCT03223961)...Over a median follow-up period of 34 months, 14 (32%) patients in the early onset arm became RBC TD; in the late onset arm, this figure was 18 (44%). Of the 84 participants in this study, 63 were on ESAs for a minimum of 12 weeks. For the patients in the early onset arm, the HI-E was 79.5%; for the patients in the late onset arm, the HI-E was 54%. The duration of HI-E was longer in the early onset cohort (median, 30.6 months) compared with the late onset cohort (median, 12.7 months)."

P3 data • Myelodysplastic Syndrome

NCI-2009-01173: Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia (clinicaltrials.gov) - P3 | N=247 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2024 ➔ Oct 2025

Combination therapy • Trial completion date • Anemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • CDC25C • GNRP • PTPRC • STAT5

Efficacy of Epoetin Alfa in Managing Symptomatic Anaemia in Low-Risk Myelodysplastic Syndromes: A Retrospective Analysis. (PubMed, Cureus) - "Epoetin alfa (Eprex®) is now a mainstay in the management of symptomatic anaemia in low-risk MDS patients, reducing transfusion dependence and improving the quality of life in this patient group. This study highlights its efficacy and provides valuable predictive information, particularly showing that patients with lower baseline EPO levels are more likely to respond to treatment. While prior transfusion dependence did not significantly predict response to therapy in this cohort, it was associated with the duration of transfusion independence."

Journal • Retrospective data • Anemia • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

A randomized phase I/ II multicenter study evaluating combination of luspatercept in LR-MDS without RS having failed or being ineligible to ESA Étude multicentrique de phase I/II randomisée évaluant luspatercept seul ou en association avec l’ASE (Agent Stimulant l’Erythropoïèse) dans les Syndromes Myélodysplasiques de faible risque non sidéroblastiques en échec ou non éligibles aux Agents... (clinicaltrialsregister.eu) - P1/2 | N=150 | Ongoing | Sponsor: Groupe Francophone des Myélodysplasies

New P1/2 trial • Hematological Malignancies • Myelodysplastic Syndrome • Systemic Lupus Erythematosus

ENCASE: Comparative Study of Two Recombinant Human Erythropoietin Products on Chronic Kidney Disease Patients (clinicaltrials.gov) - P3 | N=280 | Not yet recruiting | Sponsor: Megalabs

New P3 trial • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Short versus long-acting erythropoiesis-stimulating agents for anemia management in Egyptian hemodialysis patients. (PubMed, Qatar Med J) - P | "In hemodialysis Egyptian patients, Aranesp with extended dosing intervals proved to be more effective in achieving target Hb with comparable adverse effect profiles, a substantial cost-saving strategy, and offered time-saving advantages for medical staff workload compared to Eprex."

Journal • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Study to Compare the Safety and Efficacy of UB-851 and Eprex® (clinicaltrials.gov) - P3 | N=269 | Completed | Sponsor: UBI Pharma Inc. | Unknown status ➔ Completed

Trial completion • Anemia • Hematological Disorders

NCI-2009-01173: Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia (clinicaltrials.gov) - P3 | N=247 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2023 ➔ Sep 2024

Combination therapy • Trial completion date • Anemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A Case of Dialysis-Dependent Rapidly Progressing C3 Glomerulonephritis (KIDNEY WEEK 2023) - "Baseline Hb was lower in Eprex vs. Epotin group (9.9±1.3 g/dL vs. 10.8±1.3g/dL respectively) (p = 0.006). Conclusion Biosimilar epoetin® showed therapeutic equivalence with lower cost compared to originator drug (Eprex®) in maintaining Hb to target level in ESRD patients on HD. Trend of mean Hb level in both groups over the study (6 months)"

Clinical • Anemia • Chronic Kidney Disease • Complement-mediated Rare Disorders • Glomerulonephritis • Hematological Disorders • Lupus Nephritis • Nephrology • Renal Disease