Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin - LARVOL DELTA

[VIRTUAL] The Commands Trial: A Phase 3 Study of the Efficacy and Safety of Luspatercept Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low-, Low-, or Intermediate-Risk MDS in Erythropoiesis Stimulating Agent-Naive Patients Who Require RBC Transfusions (ASH 2020) - P3 | "Recent studies of epoetin alfa and darbepoetin alfa have demonstrated efficacy among patients with LR-MDS, but the patient population in whom a clinically significant effect is seen may be limited (Fenaux P, et al...Exclusion criteria include prior use of ESAs (≤ 2 doses of prior epoetin alfa permitted if ≥ 8 weeks from randomization date and sEPO confirmed as ≤ 500 U/L), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF), unless given for the treatment of febrile neutropenia; disease-modifying agents (e.g. lenalidomide), or hypomethylating agents; and presence of del(5q) cytogenetic abnormality...Key secondary endpoints include duration of RBC-TI, change in Hb levels, achievement of HI-E response per International Working Group (IWG) 2006 criteria, and safety. The COMMANDS trial is registered at ClinicalTrials.gov (NCT03682536) and EudraCT (number 2017-003190-34)."

Clinical • P3 data • Anemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology • CSF2 • EPO • SF3B1

Changes in mean corpuscular volume after erythropoiesis-stimulating agent treatment are associated with renal outcomes in non-dialysis-dependent chronic kidney disease. (PubMed, Clin Exp Nephrol) - "In ESA-naïve patients with non-dialysis-dependent CKD, an increase in MCV following ESA treatment was associated with a significantly lower risk of renal function decline. Monitoring MCV dynamics may serve as a simple, adjunctive tool for risk stratification and individualized CKD management."

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

A Study to Evaluate Efficacy and Safety of QLG1218(Daprodustat) in Chinese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD) (clinicaltrials.gov) - P3 | N=100 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

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

DarbeLus: Luspatercept + Darbepoetin in MDS (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Yale University | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Clinical features and outcomes of myeloproliferative neoplasm patients with MPL mutations and concurrent JAK2/calr mutations (ASH 2025) - "ET treatments included hydroxyurea and off-label Ropeginterferon alfa-2b. Among those with MF, 7 patients received ruxolitinib, 2 required anemia-related therapies, including darbepoetin alfa and Luspatercept...However, further work is required to investigate this hypothesis. Limited follow-up and the predominance of White populations in our cohort underscore the need for studies involving larger and more diverse populations with extended longitudinal data to better understand the prognostic significance and therapeutic implications of the co-mutations."

Clinical • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Myelofibrosis • Myeloproliferative Neoplasm • Thrombocytosis • ASXL1 • CALR • JAK2 • NOTCH1 • SF3B1 • SH2B3 • SRSF2 • TET2

Utilization and outcomes of erythropoietin stimulating agents in sickle cell disease patient: A real world data analysis (ASH 2025) - "The population was divided into two cohorts based on receipt of ESAs (EPO, Epoietin alfa,Darbepoetin alfa). Propensity Score matching (PSM) was carried to match age, sex, race, chronic heartfailure, chronic lung disease, neoplasms, chronic kidney disease stages 4 and 5, use of hydroxyurea andcrizanlizumab... This real-world data shows that ESAs use does increase the utilization of hydroxyurea, but itssignificance in improving survival and sickle cell crisis still needs to be evaluated with prognostic studies.The study also highlights potential risks of arterio-venous thrombosis with the use of ESAs."

Clinical • Real-world • Real-world evidence • Anemia • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Coronary Artery Disease • Genetic Disorders • Heart Failure • Hematological Disorders • Ischemic stroke • Myocardial Ischemia • Nephrology • Pulmonary Disease • Renal Disease • Respiratory Diseases • Sickle Cell Disease • Thrombosis

Real-world comparison of thrombotic events in patients with Myelodysplastic Syndromes treated with luspatercept versus erythropoietin-stimulating agents using trinetx database (ASH 2025) - "Patients were stratified based on treatment with luspatercept or ESAs(epoetin alfa or darbepoetin alfa). In this large, multicenter real-world analysis, we observed a numerically lower incidence of thromboticevents with luspatercept compared to erythropoietin-based agents in patients with MDS, thoughdifferences did not reach statistical significance. These findings support the thrombotic safety profile ofluspatercept observed in clinical trials and warrant further prospective validation."

Clinical • Real-world • Real-world evidence • Anemia • Beta-Thalassemia • Cardiovascular • Genetic Disorders • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Respiratory Diseases • Venous Thromboembolism

BI29 Treatment-associated anaemia on Janus kinase inhibitors for atopic dermatitis: a case report, review of the literature and discussion of treatment. (PubMed, Br J Dermatol) - "We treated a 74-year-old woman with lifelong AD, refractory to multiple systemic treatments including ciclosporin, methotrexate, mycophenolate mofetil and dupilumab, with upadacitinib 30 mg daily...Haematology recommended initiation of darbepoetin alfa at 150 μg weekly...No articles in the dermatology, rheumatology or gastroenterology literature offer advice on managing JAK inhibitor-associated anaemia, nor did we find information on restarting JAK inhibitors after resolution of anaemia outside the haematology literature. However, JAK inhibitors can safely be restarted after resolution of anaemia, which is important information in management of this complication and providing patient care."

Journal • Review • Anemia • Atopic Dermatitis • Crohn's disease • Dermatitis • Dermatology • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Monoclonal Gammopathy • Pulmonary Disease • Rheumatology • JAK1 • JAK2

Safety and Efficacy of Vadadustat Versus Darbepoetin Alfa for Chronic Kidney Disease-Related Anemia in Patients Receiving Dialysis by Baseline Erythropoiesis-Stimulating Agent Dose. (PubMed, Hemodial Int) - "Comparing safety and efficacy by baseline ESA dose among patients with CKD on maintenance dialysis, vadadustat was noninferior to darbepoetin alfa for all ESA dose subgroups, including patients with high baseline ESA requirements."

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

DIVI: Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: University of Washington | Trial completion date: Dec 2027 ➔ Jun 2027 | Trial primary completion date: Dec 2025 ➔ Oct 2026

Trial completion date • Trial primary completion date • Anemia • Hematological Disorders

Therapeutic timing limitations of postnatal darbepoetin in a valproic acid rat model of Autism Spectrum Disorder. (PubMed, PLoS One) - "To address this timing gap, we administered darbepoetin alfa, a long-acting EPO analogue, to valproic acid-exposed rats beginning at postnatal day 21 for five consecutive days, and assessed ASD-relevant social and cognitive behaviors...Our findings suggest the therapeutic window for EPO analogues may close before the post-diagnostic period, highlighting a critical translational challenge: interventions effective in early neonatal windows may not retain efficacy at clinically accessible diagnostic stages. The pronounced hematological response further precludes testing whether higher doses could compensate for delayed timing, though non-erythropoietic derivatives may circumvent this limitation in future studies."

Journal • Preclinical • Autism Spectrum Disorder • Genetic Disorders • Hematological Disorders

Comparative effectiveness of darbepoetin vs other agents in chronic kidney disease-related anemia: a systematic review and network meta-analysis. (PubMed, BMC Nephrol) - "Daprodustat and roxadustat indicated equivalent or higher efficacy when compared to darbepoetin in elevating hemoglobin levels in CKD-related anemia, with daprodustat demonstrating a good safety profile. While conventional ESAs remain beneficial, HIF-PHIs offer promising oral alternatives with possible benefits in cardiovascular safety and decreased hypertension risk. Further head-to-head trials are necessary to confirm these findings and guide individualized treatment strategies."

Clinical • HEOR • Journal • Retrospective data • Review • Anemia • Cardiovascular • Chronic Kidney Disease • Diabetes • Hematological Disorders • Hypertension • Metabolic Disorders • Nephrology • Renal Disease

Phase 1b/2 Study Evaluating the Safety and Efficacy of Canakinumab with Darbepoetin Alfa in Patients with Lower-Risk Myelodysplastic Syndromes (MDS) Who Have Failed Erythropoietin Stimulating Agents (ESA) (ASH 2023) - "Additionally, 33% and 56% were refractory to lenalidomide and luspatercept therapy, respectively. The combination of canakinumab and darbepoetin was safe and well tolerated and 300mg of canakinumab is the RP2D. Canakinumab inhibited inflammasome activation as evidenced by a reduction of ASC specks although this did not translate to clinical responses. Phase 2 of the study will focus on patients with lower transfusion burden and molecular subsets with highest IL-1β expression (e.g."

Clinical • P1/2 data • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Immunology • Myelodysplastic Syndrome • Neutropenia • Oncology • Thrombocytopenia • CASP1 • DNMT3A • IL1B • TET2

Real-World Patient Characteristics, Treatment Patterns, and Outcomes in Patients with Lower-Risk Myelodysplastic Syndromes Who Have Been Treated with Luspatercept (ASH 2023) - "The two most used ESAs were darbepoetin alfa (54. 5%) and epoetin alfa (44...7% of patients had previously received a non-ESA treatment, most commonly azacitidine (62. 9%) or lenalidomide (31... This real-world study described treatment patterns and outcomes in patients with LR-MDS receiving luspatercept. An improvement in hemoglobin levels was observed in more than half of patients. In a quarter of patients who had a ≥1."

Clinical • Real-world • Real-world evidence • Anemia • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Unraveling the Clinical Spectrum: A Case Study of Classic and Aplasia-Related Paroxysmal Nocturnal Hemoglobinuria (ASH 2023) - "Enoxaparin was started for thromboses and levofloxacin for neutropenia...Darbepoetin alfa and romiplostim were added...Ravulizumab is non-inferior to eculizumab, with the added advantage of less frequent dosing (every 8 weeks versus 2 weeks)...Heparin is preferred in acute thrombotic states. Most hematologists recommend anticoagulation till a few months after starting complement inhibition."

Case study • Clinical • Anemia • Aplastic Anemia • Cardiovascular • Complement-mediated Rare Disorders • Coronary Artery Disease • Fatigue • Fibrosis • Hematological Disorders • Hematological Malignancies • Hypertension • Immunology • Infectious Disease • Meningococcal Infections • Myelodysplastic Syndrome • Neutropenia • Oncology • Paroxysmal Nocturnal Hemoglobinuria • Pulmonary Disease • Rare Diseases • Thrombosis • CD55 • CD59 • HP

The Heparinoid Sevuparin Improves Anemia and Kidney Status in a Mouse Model of Chronic Kidney Disease (ASH 2023) - "Our data in this mouse CKD model add new insights to the role of hepcidin in the development of CKD anemia over time. Furthermore, the results are promising and support further mechanistic and clinical studies to elucidate the therapeutic role for sevuparin as a treatment in anemia of inflammatory and/or chronic diseases in monotherapy or in combination with EPO and to explore its role in kidney protection."

Preclinical • Anemia • Chronic Kidney Disease • Fibrosis • Hematological Disorders • Immunology • Inflammation • Nephrology • Renal Disease • BMP6 • IL6

Erythropoiesis-Stimulating Agent Protects Against Kidney Fibrosis by Inhibiting G2/M Cell Cycle Arrest. (PubMed, Cells) - " Human kidney 2 (HK-2) cells were stimulated with TGF-β or paclitaxel, treated with darbepoetin alfa (DARB) at 0.5 ug/mL or 5 ug/mL, and cell cycles were analyzed using flow cytometry. Finally, DARB treatment demonstrated an anti-fibrotic effect in HK-2 cells stimulated with TGF-β or paclitaxel, comparable to that of a p53 inhibitor. DARB treatment decreased G2/M cell phase arrest and attenuated kidney fibrosis, suggesting a new renoprotective mechanism for ESA."

Journal • Acute Kidney Injury • Chronic Kidney Disease • Fibrosis • Immunology • Nephrology • Renal Disease • TGFB1

AnemiaCare HD: Achieving Protocol-Adherent Anemia Management in Hemodialysis Using a Deterministic Large Language Model (LLM) Framework (KIDNEY WEEK 2025) - "Comprehensive encoding of domain-specific operational rules is essential to ensuring safety, auditability, and sustained clinical trust. Future directions include integration with electronic health records, optimization of dose calculation algorithms, and prospective validation studies in real-world dialysis environments."

Clinical • Anemia • Hematological Disorders

Comparison of Darbepoetin Alfa (Aranesp) Dosing in Hospitalized Patients with Kidney Diseases (KIDNEY WEEK 2025) - "Conclusion In hospitalized kidney disease patients, initial dosing of 100 mcg of DA was associated with greater levels of increase in hemoglobin in the first 3 weeks as compared to initial dosing of 60 mcg. We recommend using the higher dose of 100 mcg of DA when treating hemoglobin concerns in hospitalized kidney disease patients."

Clinical • Anemia • Hematological Disorders • Hypertension • Inflammation • Nephrology • Renal Disease

Win-Odds Analysis of Deaths and Hospitalization in Patients Taking Vadadustat or Darbepoetin Alfa for CKD-Related Anemia Undergoing Dialysis (KIDNEY WEEK 2025) - "The win odds (95% CI) for VADA compared to DA was 0.93 (0.87–0.99; p=0.03). Conclusion In a post-hoc analysis, the composite of all-cause mortality and hospitalizations was statistically significantly lower for VADA compared to DA in a win-odds analysis among patients with DD- CKD."

Clinical • Anemia • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Myocardial Infarction

Acute Kidney Injury after Cardiac Surgery Is Associated with Increased Iron Deficiency Anemia Risk (ASH 2024) - "Exclusion criteria included diagnoses of acute kidney failure (ICD-10-CM N17), chronic kidney disease (N18), end stage renal disease (N18.6), renal dialysis (Z99.2), and hemoglobin ≤8 g/dL within 1-month preoperatively.A propensity-matched cohort analysis was used to examine the relationship between 7-day postoperative AKI and 3-month, 6-month, and 12-month postoperative mortality, all cause anemia, iron deficiency anemia (D50), repeat cardiac surgery, RBC transfusion, acute myocardial infarction (MI) (I21), atrial fibrillation and flutter (I48), and recent hemoglobin (Hb) and hematocrit (Hct) levels within the outcome period.Propensity score matching was performed for age, ethnicity, race, sex, preoperative diabetes mellitus (E08-E13), neoplasms (C00-D49), alcohol related disorders (F10), liver diseases (K70-K77), sepsis (A40-41), MI, cerebral infarction (I63), essential hypertension (I10), renal tubulo-interstitial diseases (N10-N16), acute and subacute endocarditis..."

Surgery • Acute Kidney Injury • Anemia • Atrial Fibrillation • Cardiovascular • Chronic Kidney Disease • CNS Disorders • Diabetes • Diabetic Nephropathy • Hematological Disorders • Hepatology • Hypertension • Infectious Disease • Metabolic Disorders • Myocardial Infarction • Nephrology • Renal Disease • Septic Shock

Risks and Harms to Physicians Reporting Hematologic Adverse Drug Reactions (ADRs) to Health Authorities (ASH 2024) - "ADR findings resulted in drug removal (n = 7; Vioxx, Avandia, Bextra, Celebrex, Trasylol, Phenyl propanolamine, Hydroxy-ethyl starch), revised indications (n = 2) (Procrit, Aranesp 2007, 2008, 2010)) or 10-year delay in FDA-approval (n = 1) (Fereprox)...Pharmaceutical companies paid $600,000 (Fereprox) to $5.8 billion (Vioxx) in fines and settlements.Discussion : Twelve physicians experienced severe threats and/or harms after reporting hematologic-associated ADRs to Health Authorities and/or in major publications. We suggest physicians not sign secrecy agreements that might jeopardize public safety (as currently established by almost all US medical universities) and should partner with independent drug safety monitoring boards (DSMBs) on ADR evaluations to monitor safety concerns of drugs and medical devices."

Adverse drug reaction • Hematological Disorders • Oncology • Solid Tumor

Iron Tablet Gastropathy: When Iron Supplementation for GI Bleeding Leads to More GI Bleeding (ACG 2025) - "Case Description/ A 67-year-old female with a history of CLL on darbepoetin alfa and iron deficiency anemia, presented to the ED for evaluation of hematemesis and melena...She denied recent alcohol, NSAID, aspirin, or anticoagulant use...She was transfused blood and given intravenous pantoprazole...(B) Higher power view of hyperplastic gastric mucosa with brown crystalline deposits (200x; H&E). (C) Brown crystalline deposits are positive with iron histochemical staining (200x)."

Acute Kidney Injury • Anemia • Constipation • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Inflammation • Nephrology • Renal Disease

Mechanical Support Escalation to Bridge Anemic Jehovah's Witness to Cardiac Transplantation. (PubMed, J Clin Med) - "During mechanical support, he was given a total blood conservation plan that included intravenous iron, darbepoetin alfa, restricted phlebotomy, and nutritional supplementation... Transfusion religious objection ought not preclude JW patients from lifesaving OHT. With judicious perioperative planning, third-generation transvalvular pumps, and hematologic optimization, "bloodless" heart transplantation is possible-potentially even in non-ideal candidates."

Journal • Cardiomyopathy • Cardiovascular • Hematological Disorders • Transplantation

Erythropoiesis-stimulating agent hyporesponsiveness and malignancy development in patients with non-dialysis chronic kidney disease: a prospective cohort study. (PubMed, Clin Exp Nephrol) - "Both initial ESA hyporesponsiveness and subsequent declines in responsiveness were significantly associated with the development of malignancy in patients with NDD-CKD. ESA hyporesponsiveness may serve as a clinical marker that reflects an increased risk of undiagnosed malignancy."

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