- |||||||||| AND017 / Hangzhou Andao Pharma
Enrollment open, Trial primary completion date: A Study of AND017 to Treat Anemia in Chronic Kidney Disease Patients on Dialysis (clinicaltrials.gov) - Oct 6, 2023 P2, N=120, Recruiting, Desensitization and Epoetin structural changes could be successful methods to re-introduce the drug. Not yet recruiting --> Recruiting | Trial primary completion date: Jun 2024 --> Mar 2024
- |||||||||| Epogen (epoetin alfa) / Amgen
Trial completion, Enrollment change, Trial primary completion date: Impact of Erythropoietin on Hematological Adaptations and Physical Performance (clinicaltrials.gov) - Sep 21, 2023 P4, N=8, Completed, Luspatercept safety was comparable with previous MDS reports; luspatercept may represent a new standard of Tx in TD LR-MDS. Recruiting --> Completed | N=24 --> 8 | Trial primary completion date: Dec 2022 --> Apr 2023
- |||||||||| Epogen (epoetin alfa) / Amgen
Orthotopic Liver Transplantation in a Jehovah's Witness Recipient (Exhibit Hall) - Aug 23, 2023 - Abstract #ASA2023ASA_4195; Epoetin-alfa was planned to optimize preoperative hematocrit, but suitable liver donorship became available before insurance approval...Cell-saver was prepared, but held due to risk of seeding bloodstream with malignant cells. Patient was extubated without need for vasopressors and successfully discharged one week later.
- |||||||||| Epogen (epoetin alfa) / Amgen, Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
P3 data, P3 data: top line, Journal: Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomised controlled trial. (Pubmed Central) - Jul 31, 2023 P3 In this interim analysis, luspatercept improved the rate at which red blood cell transfusion independence and increased haemoglobin were achieved compared with epoetin alfa in ESA-naive patients with lower-risk myelodysplastic syndromes. Long-term follow-up and additional data will be needed to confirm these results and further refine findings in other subgroups of patients with lower-risk myelodysplastic syndromes, including non-mutated SF3B1 or ring sideroblast-negative subgroups.
- |||||||||| hydroxyurea / Generic mfg.
Enrollment open, Enrollment change: ACHiEvE-SCD: Hydroxyurea and EPO in Sickle Cell Disease (clinicaltrials.gov) - Jul 14, 2023 P1/2, N=15, Recruiting, Long-term follow-up and additional data will be needed to confirm these results and further refine findings in other subgroups of patients with lower-risk myelodysplastic syndromes, including non-mutated SF3B1 or ring sideroblast-negative subgroups. Not yet recruiting --> Recruiting | N=25 --> 15
- |||||||||| Mircera (methoxy polyethylene glycol-epoetin beta) / Roche, Epogen (epoetin alfa) / Amgen, HyPoietin (epoetin alfa biosimilar) / GC Biopharma, Genexine, Fosun Pharma
OPEN LABEL, NON-INFERIORITY, RANDOMIZED, ACTIVE-CONTROLLED, PHASE III CLINICAL STUDY OF EPOETIN ALFA VERSUS METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA FOR TREATMENT OF ANAEMIA IN CKD NON-DIALYSIS PATIENT () - Mar 28, 2023 - Abstract #ISNWCN2023ISN_WCN_935; A total of 322 adverse events (AE) in 99 patients (69.7%) in Epoetin Alfa group and 264 AE in 91 patients (64.5%) in Methoxy Polyethylene Glycol-Epoetin Beta group. Conclusions Based on this study, the interim data indicates that the Epoetin Alfa and Methoxy Polyethylene Glycol-Epoetin Beta have comparable efficacy and safety profiles for anaemia in CKD-non-dialysis patients.
- |||||||||| Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Trial completion date: COMMANDS: A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Na (clinicaltrials.gov) - Feb 6, 2023 P3, N=347, Active, not recruiting, Keywords: Mutation analysis, Myelodysplastic syndrome,Erythropoieisis, Clinical trial Trial completion date: Feb 2028 --> Sep 2027
- |||||||||| Epogen (epoetin alfa) / Amgen, Retacrit (epoetin alfa-epbx) / Stada, Norbitec, Pfizer
Journal: Pharmacist-driven epoetin alfa-epbx dosing for hospitalized patients. (Pubmed Central) - Jan 22, 2023 The optimal management of ESAs in patients presenting with MI or CVA should be further explored. Pharmacist-driven ESA dosing was associated with significant decreases in ESA average acquisition cost and average total dose per patient.
- |||||||||| AND017 / Hangzhou Andao Pharma
Trial completion date, Trial initiation date, Trial primary completion date: A Study of AND017 to Treat Anemia in Chronic Kidney Disease Patients on Dialysis (clinicaltrials.gov) - Dec 22, 2022 P2, N=120, Not yet recruiting, This case highlights the importance of patient-specific therapies in the treatment of this complex syndrome. Trial completion date: Aug 2023 --> Jun 2024 | Initiation date: Aug 2022 --> Jan 2023 | Trial primary completion date: Aug 2023 --> Jun 2024
- |||||||||| hydroxyurea / Generic mfg.
Trial completion date, Trial primary completion date: ACHiEvE-SCD: Hydroxyurea and EPO in Sickle Cell Disease (clinicaltrials.gov) - Nov 25, 2022 P1/2, N=25, Not yet recruiting, Trial completion date: Aug 2023 --> Jun 2024 | Initiation date: Aug 2022 --> Jan 2023 | Trial primary completion date: Aug 2023 --> Jun 2024 Trial completion date: Aug 2024 --> Jun 2025 | Trial primary completion date: May 2024 --> Sep 2024
- |||||||||| Epogen (epoetin alfa) / Amgen
Journal: Jehovah's witness head and neck free flap reconstruction patient outcomes. (Pubmed Central) - Nov 8, 2022 Free flap microvascular reconstruction can be reliably performed on Jehovah's Witness head and neck patients without an increased risk of complication. Policies such as the use of non-blood volume expanders, albumin, Epogen, perioperative iron supplementation, cell saver and acute normovolemic hemodilution are key to ensuring good outcomes.
- |||||||||| Epogen (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
A First-in-Human Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of Polyethylene Glycol-Erythropoietin Injection, RD01, in Healthy Volunteers (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_1827; rHuEPO (both a and ?, which are almost identical to endogenous erythropoietin in the sequence of amino acids, but are distinct in their glycosylation pattern) have short half-life in 6 to 24 hours after intravenous (IV) or subcutaneous (SC) injection (Halstenson 1991; Salmonson 1990), Darbepoetin alfa, which is more highly glycosylated epoetin and has a longer half-life in 24 to 72 hours (Macdougall 2007; Padhi 2006) and CERA is a pegylated rHuEPO ?... RD01 (0.2-4.8 µg/kg) was well tolerated by healthy Chinese subjects with a much longer t1/2, that supported further clinical development of RD01 (above 0.8 µg/kg) for patients with anemia.
- |||||||||| hydroxyurea / Generic mfg.
Enrollment open: ACHiEvE-SCD: Hydroxyurea and EPO in Sickle Cell Disease (clinicaltrials.gov) - Oct 24, 2022 P1/2, N=25, Recruiting, RD01 (0.2-4.8 µg/kg) was well tolerated by healthy Chinese subjects with a much longer t1/2, that supported further clinical development of RD01 (above 0.8 µg/kg) for patients with anemia. Not yet recruiting --> Recruiting
- |||||||||| Epogen (epoetin alfa) / Amgen
Acute PD in ESKD Jehovah's Witness Patient With Severe Anemia and Uremic Bleeding () - Oct 15, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_4304; Anemia was managed with aggressive ESA dosing - Epogen 40K units qHS, started day 16...While our patient experienced further bleeding after catheter placement, he still had improvement in his hemoglobin over one week of PD. This supports using acute PD when ESRD patients may be too unstable for HD due to severe anemia.
- |||||||||| Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen
Efficacy and Safety of Roxadustat in Peritoneal Dialysis CKD: Pooled Analysis of Four Phase 3 Studies (Exhibit Hall, Orange County Convention Center‚ West Building) - Oct 13, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_2826; The incidence rates per 100 patient-exposure years for overall TEAEs (56.5 vs 54.4), grade ≥3 TEAEs (27.7 vs 27.5), and serious TEAEs (37.2 vs 35.8) were similar in the roxadustat and the ESA treatment groups, respectively. Conclusion This pooled analysis demonstrates that roxadustat, an oral medication, corrected and maintained Hb levels in patients with anemia of CKD on PD similarly to ESAs with a comparable safety profile.
- |||||||||| Epogen (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
Examining the Magnitude of Erythropoiesis-Stimulating Agent Hyporesponsiveness in Hemodialysis Patients (Exhibit Hall, Orange County Convention Center, West Building) - Oct 13, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_2553; Conclusion Prevalence of high ERI in HD patients exceeds 15%, mostly due to the scale of ESA dosing, but this overstates the prevalence of chronic anemia hyporesponsive to treatment. Lower TSAT is common in patients with high ERI and/or chronically low Hb, suggesting potential iron deficiency.
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