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

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

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

Hepatic modulation of apelin and galectin-3 by darbepoetin-alpha in Dexamethasone induced insulin-resistant rats. (PubMed, BMC Pharmacol Toxicol) - No abstract available

Journal • Preclinical • Fibrosis • Immunology • Liver Cirrhosis

Potential Association Between Darbepoetin Alfa Administration and Reduced Proteinuria in Real-World Clinical Practice: A Post Hoc Analysis of the BRIGHTEN Study. (PubMed, Nephrology (Carlton)) - "DA administration was associated with reduced proteinuria in a dose-dependent manner, particularly in patients with DKD."

Journal • Observational data • Real-world evidence • Retrospective data • Chronic Kidney Disease • Diabetic Nephropathy • Glomerulonephritis • Hematological Disorders • Lupus Nephritis • Nephrology • Renal Disease

A SINGLE-CENTER ANALYSIS OF DARBEPOETIN EFFICACY IN EPOETIN-REFRACTORY PEDIATRIC PATIENTS (ESPN 2025) - "In suboptimal responders, darbepoetin alfa (DA) may improve hemoglobin (Hb)... In this cohort of predominantly dialysis-dependent pediatric CKD patients, switching from rHuEPO to DA was associated with a significant increase in Hb (ΔHb +2.4 g/dL) and a marked reduction in ERI (ΔERI −13.9) over six months. Concurrent iron supplementation and higher serum iron levels likely supported these hematologic gains. These findings underscore the potential utility of DA in rHuEPO refractory pediatric anemia."

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

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

Posterior Reversible Encephalopathy Syndrome Potentially Associated With Erythropoietin Analogs: A Case Report. (PubMed, Cureus) - "We report a patient with end-stage renal disease presenting with PRES that occurred four months after commencing darbepoetin alfa and closely correlated with darbepoetin use...Re-challenging the patient upon recurrence strengthened the causal link. Therefore, we emphasize that healthcare providers should maintain a high index of suspicion for PRES related to EPO in patients in the ICU with hypertension who develop neurological symptoms."

Journal • Cardiovascular • Chronic Kidney Disease • CNS Disorders • Critical care • Epilepsy • Hematological Disorders • Hypertension • Nephrology • Renal Disease

Effects of Daprodustat on Iron Metabolism in Peritoneal Dialysis Patients: An Exploratory Study. (PubMed, Blood Purif) - "Methods This single-center, prospective study included 11 patients undergoing maintenance peritoneal dialysis who shifted from darbepoetin alfa to daprodustat. However, the absence of significant hemoglobin improvement, combined with the small sample size (n=11), lack of control group, and short 24-week follow-up period, significantly limits the clinical relevance and generalizability of these findings. Larger randomized controlled trials with longer follow-up periods are essential to definitively establish the efficacy and safety of daprodustat in this patient population."

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

Impact of Iron Deficiency and Erythropoiesis-Stimulating Agents on Anemia in CKD Progression. (PubMed, Int J Nephrol) - "The ESA treatment given consisted of epoetin alfa or darbepoetin alfa, with iron supplementation given according to iron-deficiency status. ESA treatment improves anemia and retards renal deterioration, especially when coupled with iron supplementation. Early detection and correction of anemia might merit interplay in pursuit of optimized CKD outcomes."

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

Darbepoetin Alfa Once Monthly Dosing Schedule Maintains Hemoglobin Concentration Comparable to Every 2 Weeks Dosing Schedule in Advanced Chronic Kidney Disease Patients Not on Dialysis: A Multicenter, Phase 4 Study (clinicaltrials.gov) - P4 | N=40 | Active, not recruiting | Sponsor: Gangnam Severance Hospital | N=77 ➔ 40

Enrollment change • Chronic Kidney Disease • Congestive Heart Failure • Nephrology • Renal Disease

Characterization of the glycosylation profile of erythropoiesis-stimulating agents (ESAs) and impact on potency. (PubMed, J Pharm Biomed Anal) - "The hyper-glycosylated ESA darbepoetin alfa was also assessed to understand the range of in vivo potency response. Results demonstrate a strong link between sialylation or antennary structure, but not between N-acetyllactosamine repeat number and in vivo potency. Results for darbepoetin as compared to epoetin also confirm an inverse relationship between in vivo potency and potency measured using in vitro methods."

Journal

Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA (clinicaltrials.gov) - P1/2 | N=13 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Oct 2025 ➔ Jul 2026

Trial completion date • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

DarbeLus: Luspatercept + Darbepoetin in MDS (clinicaltrials.gov) - P2 | N=54 | Not yet recruiting | Sponsor: Yale University

New P2 trial • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Effect of Erythropoiesis-Stimulating Agent Types on Hemoglobin Variability in Hemodialysis Patients. (PubMed, J Clin Med) - "ESAs are categorized into short-acting (epoetin alfa/beta/delta, requiring more frequent administration), intermediate-acting (darbepoetin alfa), and long-acting agents (methoxy polyethylene glycol-epoetin beta, requiring extended dosing intervals), each with distinct pharmacokinetic properties and dosing schedules. Our cohort study found that the use of short-acting ESAs showed the lowest hemoglobin variability, whereas the use of intermediate-acting ESAs showed the highest variability. In the context of South Korea's healthcare system, where frequent hemoglobin monitoring and strict ranges are emphasized, short-acting ESAs combined with regular laboratory follow-up appeared to support more stable hemoglobin levels."

Journal • Cardiovascular • Renal Disease

Unveiling Vadadustat: Comprehensive Review of its Chemistry, Pharmacology, Bioanalysis, and Patent Landscape as a Novel HIF-PH Inhibitor. (PubMed, Curr Top Med Chem) - "This review examines therapeutic, pharmacological, analytical, and regulatory aspects related to Vadadustat."

Journal • Cardiovascular • Hematological Disorders

Unveiling the Accurate Site-Specific N- and O-Glycosylation of Hyperglycosylated Erythropoietin Drugs by an Integrated Approach. (PubMed, Anal Chem) - "We applied this strategy to compare the glycosylation profiles of the commercial hyperEPO drug darbepoetin alfa and a novel high-potency analogue, EPO-XL...Collectively, this study presents the first site-specific N- and O- glycosylation profiles of hyperEPO proteins, offering valuable guidance for the quality control and rational design of these therapeutics. The state-of-the-art analytical strategy introduced here holds great potential to advance the site-specific glycosylation characterization of proteins with complex glycosylation."

Journal

Attribute based cross classification analyses from the BRIGHTEN study reveal that therapeutic responsiveness to erythropoiesis stimulating agents predicts cardiorenal prognosis in renal anemia. (PubMed, Sci Rep) - "Darbepoetin alfa doses during 12 weeks were lowest in younger men (0.79 μg/kg) and highest in older women (1.08 μg/kg)...This study revealed that renal outcomes correlated with Hb levels and ESA responsiveness in patients with CKD and anemia, especially in younger men with poor renal outcomes and with ESA resistance in older women with the best renal outcomes. Cross-classification helps identify specific patient attributes that should be targeted for optimizing anemia treatment in CKD."

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

A Rare Case of Parvovirus Infection Causing Pure Red Cell Aplasia in a Kidney-Pancreas Transplant Recipient. (PubMed, Nephrology (Carlton)) - "He had normal haematinics, with a persistent reticulocytopenia (0.3%, 7 × 109 cells/L) despite 80 μg per week of subcutaneous darbepoetin alfa...High dose intravenous immunoglobulin (IVIG total 400 mg/kg/day over 5 days) and immunosuppression reduction led to haemoglobin stability to > 80 g/L over 14 days. Treatment response was further extrapolated by a parvovirus PCR cycle threshold increase to 25, 7 days after first IVIG dose in the absence of gold standard quantitative PCR testing unavailability."

Journal • Gastroenterology • Hematological Disorders • Infectious Disease • Peptic Ulcer • Transplantation

ANTI-HEMOJUVELIN MONOCLONAL ANTIBODY FURTHER ENHANCES HEMATOLOGIC RESPONSE TO ESA AND/OR LUSPATERCEPT IN MICE (EHA 2025) - P1, P1/2 | "DISC-0974 is currently in clinical studies to treat anemia in patients with MF (NCT05320198) and chronic kidney disease (NCT05745883)...In the DBIO-100/ESA combo study, wild-type C57BL/6J male mice were randomized to receive vehicle, darbepoetin alfa (DPO, an example of ESA; 1 or 3 ug/kg via subcutaneous route), DBIO-100 (20 mg/kg via intravenous route), or a combination of DBIO-100/DPO... These studies confirmed that DPO (an ESA) and DBIO-147 can increase hematological parameters in wild-type mice. Adding DBIO-100, a mouse anti-HJV monoclonal antibody, to either DPO or DBIO-147 led to further hematological improvements in vivo. Moreover, DBIO-100 enhanced serum iron availability for erythropoiesis in wild-type mice."

Preclinical • Anemia • Chronic Kidney Disease • Hematological Disorders • Hematological Malignancies • Myelofibrosis • Nephrology • Oncology • Renal Disease

Darbepoetin Alfa Once Monthly Dosing Schedule Maintains Hemoglobin Concentration Comparable to Every 2 Weeks Dosing Schedule in Advanced Chronic Kidney Disease Patients Not on Dialysis, Multicenter, Phase 4 Study (clinicaltrials.gov) - P4 | N=77 | Active, not recruiting | Sponsor: Gangnam Severance Hospital

New P4 trial • Chronic Kidney Disease • Nephrology • Renal Disease