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

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

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

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

EPO-T: Effects of Erythropoietin for Cognitive Side-effects of ECT (clinicaltrials.gov) - P2 | N=60 | Completed | Sponsor: Martin Balslev Jørgensen | Recruiting ➔ Completed | Trial completion date: Sep 2023 ➔ Feb 2023 | Trial primary completion date: May 2023 ➔ Jan 2023

Adverse events • Trial completion • Trial completion date • Trial primary completion date • Alzheimer's Disease • Bipolar Disorder • CNS Disorders • Cognitive Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Efficacy and safety of erythropoiesis stimulating agents (ESAs) in Myelofibrosis—A single-centre experience (BSH 2023) - "All patients received Epoetin alpha (Eprex), median starting dose was 30 000 IU weekly (range, 10 000–40 000)... ESAs are effective first-line therapies for the management of anaemia in patients with MF. Improvement in Hb may be observed as late as 15–18 weeks after initiation of ESAs. Hypertension is one of the commonest side effects, careful blood pressure monitoring is, therefore, warranted."

Clinical • Anemia • Bone Marrow Transplantation • Cardiovascular • Hematological Disorders • Hypertension • Myelofibrosis • Oncology • Thrombocytosis • Transplantation • Venous Thromboembolism

TONTT-2: Traumatic Optic Neuropathy Treatment Trial 2 (clinicaltrials.gov) - P3 | N=93 | Completed | Sponsor: Iran University of Medical Sciences | Trial completion date: Aug 2022 ➔ Mar 2023

Trial completion date • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain

PRETEC-EPO: Effects of Erythropoietin on Cognition and Neural Activity in Mood Disorders (clinicaltrials.gov) - P2 | N=103 | Completed | Sponsor: Lars Vedel Kessing | Recruiting ➔ Completed

Trial completion • Alzheimer's Disease • Bipolar Disorder • CNS Disorders • Cognitive Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Three-year safety observation of subcutaneous administration of epoetin-zeta in patients with chronic renal anemia: Results from PASCO II study. (PubMed, Clin Nephrol) - "The PASCO II study (post-authorization safety cohort observation of Retacrit and Silapo (epoetin-ζ) administered subcutaneously for the treatment of renal anemia) followed 6,346 patients (4,501 Retacrit (group R); 1,845 Silapo (group S)) for up to 3 years of subcutaneous treatment with the biosimilar epoetin-ζ. The exposure-adjusted incident rate of PRCA was 0.84 per 10,000 patient-years. This real-world study showed that among patients with renal anemia receiving subcutaneous administration of the biosimilar product epoetin-ζ, the incidence rate of PRCA was substantially below the risk observed in 2002 for Eprex and that there was no immunogenicity concern or other new safety concern."

Journal • Anemia • Cardiovascular • Hematological Disorders

Pharmacokinetic and pharmacodynamic study of 3 products of epoetin alfa as single subcutaneous dose in healthy volunteers. (PubMed, Fundam Clin Pharmacol) - "The comparison between Hemax® PFS and Eprex® resulted in similar 90%CI for C , AUC and AUC ratios, all of them within the 80-125% interval, with a power above 95% for each ratio. These findings suggest biosimilar patterns for absorption velocity (with Tmax close to 15 h), absorption extent and elimination (with an elimination half-life close to 25-30 h for each formulation)."

Journal • PK/PD data

Biosimilar erythropoietin in anemia treatment (BEAT)-Efficacy and safety of a 1:1 dose conversion from EPREX® to EPIAO® in patients with end-stage renal disease on hemodialysis: A prospective, randomized, double blind, parallel group study. (PubMed, Medicine (Baltimore)) - "EPIAO® demonstrated promising effectiveness and manageable safety in patients with end-stage renal disease on hemodialysis."

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

BEAT_002: Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study) (clinicaltrials.gov) - P3 | N=207 | Completed | Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. | Recruiting ➔ Completed

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