Mircera (methoxy polyethylene glycol-epoetin beta) / Roche, CSL Behring - LARVOL DELTA

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

Simulated Effect of Continuous Erythropoietin Receptor Activator Monthly vs. Every Two-Week Dosing on Hemoglobin in Anemia Correction of Patients on Dialysis (KIDNEY WEEK 2025) - "Funding Commercial Support – Vifor Fresenius Medical Care Renal Pharma Background Methoxy polyethylene glycol epoetin beta (Continuous EPO Receptor Activator C.E.R.A.) is indicated for treatment of anemia in chronic kidney disease...Prospective trials or real-world data are needed for confirmation. Median Hb and CERA dose over time"

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

Retraining the Anemia Control Model (ACM) for the North American Dialysis Population: A Large-Scale In-Silico Trial (KIDNEY WEEK 2025) - "Our focus is on adapting the model to methoxy polyethylene glycol-epoetin beta (MPG-E), a drug more commonly used in the U.S., and revising ESA dosing strategies to reflect regional treatment targets (10–11 g/dL in the U.S. vs. 10–12 g/dL in Europe)...Retraining improved performance and preserved fairness across demographics. In-silico validation showed effective hemoglobin control and reduced ESA use."

Clinical • Anemia • Chronic Kidney Disease • Hematological Disorders

Physiology-Driven Transformer Model to Predict Hemoglobin Response and Personalize Erythropoiesis-Stimulating Agent Dosing in Hemodialysis (KIDNEY WEEK 2025) - "Clinical, dialysis, and laboratory data were structured into an event-based dataset, where each event included pre-dose Hgb, Mircera® and iron doses, and follow-up Hgb 7–21 days later...Conclusion By integrating pharmacodynamics with sequential clinical data, our transformer-based model provides a novel framework for individualized hemoglobin prediction. This approach may inform future efforts to optimize ESA dosing in hemodialysis care."

Anemia • Diabetes • Hematological Disorders • Metabolic Disorders • Renal Disease

Study of the Efficacy and Safety of BCD-131 and Mircera® in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis (clinicaltrials.gov) - P3 | N=228 | Recruiting | Sponsor: Biocad

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

Selection, characterization and the application of the RNA aptamer in the capture assay of Erythropoietin (EPO). (PubMed, Talanta) - "REPORA-6 RNA aptamer also retains its binding against degylosylated EPO and interacts with both Epoetin Beta and Mircera, suggesting that this aptamer binds to the protein domain of the recombinant EPO despite the variation in the glycosylation side chains...We have incorporated this aptamer into a capture assay and found out that the limit of detection achieved was 19.6 pM. REPORA-6b RNA has an immense potential in applications involving doping detection of EPO."

Journal

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

Non-Inferiority of Subcutaneous Efepoetin Alfa Compared to Methoxy Polyethylene Glycol-Epoetin Beta in Stage 3 or 4 CKD Patients: Insights From a Phase 3 Trial. (PubMed, Nephrology (Carlton)) - "Efepoetin alfa demonstrated non-inferiority to methoxy polyethylene glycol-epoetin beta in correcting anaemia and maintaining haemoglobin (Hb) levels among stage 3 and 4 CKD patients. Moreover, the safety profile of efepoetin alfa was comparable to methoxy polyethylene glycol-epoetin beta."

Biomarker • Clinical • Head-to-Head • Journal • P3 data • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Transcriptomic Biomarkers in Blood Indicative of the Administration of Recombinant Human Erythropoietin to Thoroughbred Horses. (PubMed, Drug Test Anal) - "Machine learning of blood transcriptomes has enabled the discrimination of samples with or without Mircera administration. Therefore, our study has provided new insights into the biological mechanism of erythropoiesis caused by rhEPO administration in horses and has provided evidence supporting the control of misuse of ESAs by monitoring the equine blood transcriptome."

Biomarker • Journal

Vadadustat (Vafseo) for anemia of chronic kidney disease. (PubMed, Med Lett Drugs Ther) - No abstract available

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

Alebund Pharmaceutical announced the 1st closing of RMB 550 million in Series C financing (PRNewswire) - "This round of financing will support Alebund in advancing the development and commercial activities of its pipelines in renal disease and to accelerate the development of multiple clinical-stage programs. The fund will support accelerating new drug application (NDA) in China for the best-in-class iron-based phosphate binder AP301 and the conduct of its global pivotal study; the conduct of US/China phase 2 study for the first-in-class pan phosphate transporter inhibitor AP306, and further commercial expansion for Mircera in China."

Financing • Chronic Kidney Disease • Renal Disease

VOICE: Vafseo Outcomes In-Center Experience (clinicaltrials.gov) - P3 | N=2200 | Recruiting | Sponsor: USRC Kidney Research | Not yet recruiting ➔ Recruiting

Enrollment open • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Hemoglobin (hgb) Target Range Associated with All-Cause Repeated Hospitalization in Patients on Hemodialysis Treated with Mircera (KIDNEY WEEK 2024) - "Current US guidelines call for a hgb target range of 10 to 11 g/dL. In our observational research, we identified a wider and higher hgb range to be associated with lower all-cause hospitalization. Limitations of retrospective research apply."

Clinical • Anemia • Diabetes • Hematological Disorders • Metabolic Disorders

Association of Risk of Death and Hemoglobin (hgb) Variability in Anemia Management of Patients on Hemodialysis (KIDNEY WEEK 2024) - "For the current analysis we studied hgb variability in different strata of cumulatively administered long-acting ESA (Mircera). We defined the baseline period as 6 months from the first ESA dose which had to be administered within 90 days of HD initiation... Current US guidelines indicate hgb target range of 10 to 11 g/dL when treated with ESAs. Our retrospective research identified a wider and higher hgb range to be associated with lower mortality rates independent of variability. Based on the bivariate investigation, increased variability seems to confer a more accentuated risk increase at higher cumulative ESA doses."

Clinical • Anemia • Diabetes • Hematological Disorders • Metabolic Disorders

New Transcriptomic Biomarkers for Detection of the Recombinant Human Erythropoietin (rHuEPO) MirCERA in Horses. (PubMed, Drug Test Anal) - "In addition, an upregulation of the mRNA levels of the three genes was observed after analysis of blood samples collected from MirCERA-treated animals, with kinetics similar to those previously documented in humans. Our data suggest that ALAS2 and CA1 are promising indirect biomarkers for the detection of recombinant EPO abuse in horses, as observed in humans."

Biomarker • Journal • SLC4A1

Discovery of Biomarkers of a Recombinant Human Erythropoietin Administration to Thoroughbred Geldings by Label-Free Proteomics. (PubMed, Drug Test Anal) - "In this study, we applied label-free proteomics to discover plasma protein biomarkers in Thoroughbred geldings after administration with a long-acting form of recombinant human erythropoietin (rhEPO), methoxy polyethylene glycol epoetin beta, Mircera...This is the first report on the discovery of plasma protein biomarkers of rhEPO administration to geldings. The results lay a foundation for applications of protein biomarkers for controlling the misuse of ESAs."

Biomarker • Journal • HP • LGALS3 • LGALS3BP • PLTP • TFRC • VCAM1

VOICE: Vafseo Outcomes In-Center Experience (clinicaltrials.gov) - P3 | N=2200 | Not yet recruiting | Sponsor: USRC Kidney Research

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

A Study of AND017 to Treat Anemia in Chronic Kidney Disease Patients on Dialysis (clinicaltrials.gov) - P2 | N=175 | Completed | Sponsor: Kind Pharmaceuticals LLC | Active, not recruiting ➔ Completed | N=120 ➔ 175

Enrollment change • Trial completion • Anemia • Chronic Kidney Disease • Hematological Disorders • Myelodysplastic Syndrome • Nephrology • Renal Disease

Effects of individualized anemia therapy on hemoglobin stability: a randomized controlled pilot trial in hemodialysis patients. (PubMed, Clin J Am Soc Nephrol) - "Our results demonstrated an improved hemoglobin target attainment and variability by employing personalized ESA recommendations using the physiology-based anemia therapy assistance software."

Journal • Anemia • Hematological Disorders • Renal Disease

ROQ-IT: A Prospective Interventional Study Assessing the Clinical and Operational Effectiveness of Transitioning From Mircera to Daprodustat for the Treatment of Anemia in End Stage Kidney Disease (clinicaltrials.gov) - P4 | N=161 | Completed | Sponsor: USRC Kidney Research | Active, not recruiting ➔ Completed | Trial completion date: Nov 2023 ➔ Feb 2024 | Trial primary completion date: Nov 2023 ➔ Feb 2024

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

Effect of methoxy polyethylene glycol-epoetin beta on delaying dialysis in anemic patients with Stage 4-5 chronic kidney disease (ERA-EDTA 2024) - "The study indicates that using methoxy polyethylene glycol-epoetin beta to maintain a higher Hb target in anemic patients with stage 4-5 CKD does not significantly alter the rate of all-cause mortality, the initiation of KRT, and rate of eGFR decline compared to a lower Hb target. However, a higher Hb target may reduce the need for blood transfusions without adversely affecting the progression of CKD, hospitalization rates, or quality of life. These findings suggest that while higher Hb targets may not dramatically alter key clinical outcomes, they could offer benefits in reducing transfusion requirements, thus providing a more nuanced approach to managing anemia in late-stage CKD."

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

Methoxy polyethylene glycol-epoetin beta (MPG-EPO)dosing for the management of anemia: What is the correct maximal dose? (NKF-SCM 2024) - "In our study, the majority of patients on high dose MPG-EPO were receiving doses higher than the recommended dose (mostly those with lower weights). By using an arbitrary single maximal dose, we may be causing potential harm to the patients receiving significantly higher than recommended doses and incurring in unnecessary costs. In contrast, those with higher weights may be underdosed."

Anemia • Chronic Kidney Disease • Hematological Disorders

Daprodustat (Jesduvroq) for anemia of chronic kidney disease. (PubMed, Med Lett Drugs Ther) - No abstract available

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

A Study of AND017 to Treat Anemia in Chronic Kidney Disease Patients on Dialysis (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Kind Pharmaceuticals LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Anemia • Chronic Kidney Disease • Hematological Disorders • Myelodysplastic Syndrome • Nephrology • Renal Disease

Clinical Experience of a Long-acting Pegylated Erythropoietin-Stimulating Agent in Pediatric Chronic Kidney Disease. (PubMed, J Pediatr Pharmacol Ther) - "Mircera appears safe and effective in pediatric patients with CKD."

Journal • Chronic Kidney Disease • Endocrine Disorders • Hematological Disorders • Nephrology • Pediatrics • Renal Disease