Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin 
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  • ||||||||||  Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin, Velphoro (sucroferric oxyhydroxide) / Fresenius Kabi, Kissei
    Journal:  Integrative Analysis of Drug Co-Prescriptions in Peritoneal Dialysis Reveals Molecular Targets and Novel Strategies for Intervention. (Pubmed Central) -  Jun 13, 2025   
    Two further distinct categories of drugs emerged as particularly interesting in our study: selective serotonin reuptake inhibitors (SSRIs), which were found to modulate molecules implicated in peritoneal fibrosis, and vascular endothelial growth factor (VEGF) inhibitors, which exhibit anti-fibrotic properties that are potentially useful for PD. This comprehensive exploration of drug co-prescriptions in the context of PD-related pathomechanisms provides valuable insights for opening future therapeutic strategies and identifying new targets for drug repurposing.
  • ||||||||||  Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
    Retrospective data, Journal:  Mean Corpuscular Volume Is Not a Reliable Predictor of Iron Deficiency in Patients With Chronic Kidney Disease: A Post-Hoc Analysis of the BRIGHTEN Trial. (Pubmed Central) -  May 30, 2025   
    Methods This retrospective cohort study included adult patients with ND-CKD from the BRIGHTEN (oBservational clinical Research In chronic kidney disease patients with renal anemia: renal proGnosis in patients with Hyporesponsive anemia To Erythropoiesis-stimulating agents, darbepoetiN alfa) trial (enrolled from June 2014 to September 2016) in Japan who were started on darbepoetin-alpha for renal anemia and patients who were not started on iron supplementation during weeks 0-24...Conclusion Neither MCV nor the changes in MCV could reliably diagnose iron deficiency in patients with ND-CKD. Ferritin level < 130 ng/mL could predict new-onset iron deficiency within 12 weeks.
  • ||||||||||  Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin, Ilaris (canakinumab) / Novartis
    Enrollment closed, Enrollment change:  Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA (clinicaltrials.gov) -  Apr 10, 2025   
    P1/2,  N=13, Active, not recruiting, 
    Further analysis, possibly evaluating patient-level data on a larger cohort of patients with more sophisticated confounding controls, is needed to further clarify this finding. Recruiting --> Active, not recruiting | N=41 --> 13
  • ||||||||||  Cresp (darbepoetin alfa biosimilar) / Dr. Reddy&apos;s, Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
    Retrospective data, Journal, Real-world evidence:  Cresp (Pubmed Central) -  Feb 10, 2025   
    DA demonstrates impressive efficacy and safety in managing CIA, leading to substantial improvements in mean hemoglobin levels in palliative setting. This has the potential to reduce the need for blood transfusions and enhance the quality of life for patients.
  • ||||||||||  Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
    Journal:  A Simple Rapid HPLC-UV Method for Assessing C-Terminal Arginine Content in Darbepoetin Alfa. (Pubmed Central) -  Feb 7, 2025   
    All the stages of the described method (from the sample extraction to obtaining a chromatographic profile) take about 5?h. The proposed approach will be useful for laboratories developing a technology for producing recombinant darbepoetin alfa, to assess the quality of the product, and for subsequent optimization of the production process.
  • ||||||||||  Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin, Vafseo (vadadustat) / Akebia Therap
    Vadadustat for Treatment of Anemia in Older vs Younger Patients With Dialysis-Dependent-CKD (In-Person; Room: 207) -  Jan 20, 2025 - Abstract #NKFSCM2025NKF_SCM_37;    
    NI for both primary safety (MACE) and efficacy was met in each of the 2 age strata. In patients <65y, incidence of TEAEs was 87% vs 88%, and ?65y it was 89% vs 91% in VADA vs DA, respectively.Conclusion In post hoc analyses, safety and efficacy of VADA were noninferior to DA irrespective of age stratum.
  • ||||||||||  Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
    Mechanical Support Escalation to Bridge Anemic Jehovah's Witness to Cardiac Transplantation (Poster Hall) -  Jan 19, 2025 - Abstract #ISHLT2025ISHLT_1727;    
    In patients <65y, incidence of TEAEs was 87% vs 88%, and ?65y it was 89% vs 91% in VADA vs DA, respectively.Conclusion In post hoc analyses, safety and efficacy of VADA were noninferior to DA irrespective of age stratum. He was upgraded to Impella 5.5
  • ||||||||||  Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin, Ilaris (canakinumab) / Novartis
    Trial primary completion date:  Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA (clinicaltrials.gov) -  Jan 10, 2025   
    P1/2,  N=41, Recruiting, 
    He was upgraded to Impella 5.5 Trial primary completion date: Dec 2024 --> Mar 2025
  • ||||||||||  Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
    Acute Kidney Injury after Cardiac Surgery Is Associated with Increased Iron Deficiency Anemia Risk () -  Dec 7, 2024 - Abstract #ASH2024ASH_9735;    
    The increased 12-month risk of IDA and repeat cardiac surgery was mitigated with ESA treatment within 3 months with no increase in acute MI. Postoperative ESA use may protect against AKI-associated anemia without increased adverse events, representing an opportunity to improve health outcomes.
  • ||||||||||  Epogen (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
    Risks and Harms to Physicians Reporting Hematologic Adverse Drug Reactions (ADRs) to Health Authorities () -  Dec 7, 2024 - Abstract #ASH2024ASH_9597;    
    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.
  • ||||||||||  Evrenzo (roxadustat) / FibroGen
    Trial completion date, Trial primary completion date:  FOXTROT: The Effect of Roxadustat on Renal Oxygenation in Diabetes Nephropathy (clinicaltrials.gov) -  Nov 19, 2024   
    P2,  N=30, Not yet recruiting, 
    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. Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Jan 2025 --> Jan 2027
  • ||||||||||  hydralazine hydrochloride / Generic mfg.
    Hydralazine-Induced ANCA-Associated Vasculitis with Pulmonary Involvement () -  Oct 12, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_5344;    
    Diagnosis is made through history, serology for anti-histone antibodies, ANCA, low complement and biopsy of affected organs. Treatment includes discontinuation of hydralazine and immunosuppressive therapy with pulse steroids, rituximab and or cyclophosphamide..
  • ||||||||||  Vafseo (vadadustat) / Akebia Therap
    On-Treatment Analyses of Cardiovascular Safety in the Vadadustat Phase 3 Program (Exhibit Hall, Convention Center) -  Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_1958;    
    In the Phase 3 clinical program (INNO2VATE: incident dialysis-dependent [DD]-CKD or prevalent DD-CKD; PRO2TECT: ESA-untreated and ESA-treated non-DD [NDD]-CKD), VADA demonstrated noninferiority (HR=1.25 threshold) to darbepoetin alfa (DA) for MACE risk in DD-CKD (HR: 0.96, 95% CI, 0.83 to 1.11) but not NDD-CKD (HR: 1.17, 95% CI, 1.01 to 1.36) in primary ITT analyses. On-treatment dose-frequency-adjusted analyses address imbalances in PK/PD profiles and effective treatment duration between comparators and can complement results derived from ITT analyses.
  • ||||||||||  Vafseo (vadadustat) / Akebia Therap
    Safety and Efficacy of Vadadustat in Erythropoiesis-Stimulating Agent-Na (Exhibit Hall, Convention Center) -  Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_1952;    
    P3
    In the phase 3 incident INNO2VATE trial in patients new to dialysis, VADA was noninferior to the ESA darbepoetin alfa (DA) for hemoglobin (Hb) efficacy, with a similar safety profile. In this post hoc analysis of ESA-na
  • ||||||||||  Vafseo (vadadustat) / Akebia Therap
    Long-Term Safety of Vadadustat for Treatment of Anemia-Related CKD in Phase 3 Trials (Exhibit Hall, Convention Center) -  Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_1950;    
    P3
    In a safety analysis from the VADA phase 3 clinical program, VADA had a similar safety profile to darbepoetin alfa (DA) over the course of treatment with respect to treatment-emergent adverse events (TEAEs) and TEAEs of special interest (TEAESIs), including cardiovascular, hepatic, retinal, and neoplasm-related AEs. The long-term (?2 years) safety profile of VADA was similar to DA in a pooled population of patients with DD- or NDD-CKD-related anemia.
  • ||||||||||  Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin, Ilaris (canakinumab) / Novartis
    Trial completion date:  Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA (clinicaltrials.gov) -  Jul 30, 2024   
    P1/2,  N=41, Recruiting, 
    Therefore, further randomized controlled trials should determine the optimal treatment for CIA in patients with these cancers undergoing myelosuppressive chemotherapy. Trial completion date: Jun 2024 --> Aug 2025
  • ||||||||||  Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin, Vafseo (vadadustat) / Akebia Therap
    New P3 trial:  VOICE: Vafseo Outcomes In-Center Experience (clinicaltrials.gov) -  Jul 24, 2024   
    P3,  N=2200, Not yet recruiting, 
  • ||||||||||  Epogen (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
    Clinical, Retrospective data, Journal:  The effect of erythropoiesis?stimulating agents on lung cancer patients: a meta?analysis. (Pubmed Central) -  Jul 5, 2024   
    There was no statistically significant difference between the two groups in the incidence of adverse reactions (RR 0.98, 95% CI 0.95-1.00, P?=?0.10). In conclusion, ESAs does not increase the mortality of lung cancer patients or may reduce the risk of death, and can reduce the need for blood transfusion, although ESA can increase the incidence of thrombotic vascular adverse events.Registration PROSPERO CRD42023463582.
  • ||||||||||  Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin, Ilaris (canakinumab) / Novartis
    Trial completion date, Trial primary completion date:  Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA (clinicaltrials.gov) -  Apr 7, 2024   
    P1/2,  N=41, Recruiting, 
    Voxelotor resulted in a clinically significant difference in the percent change of hemoglobin from baseline to 3?months. Trial completion date: Feb 2024 --> Jun 2024 | Trial primary completion date: Feb 2024 --> Jun 2024