Sucrofer (iron sucrose similar) / Baxter Healthcare - LARVOL DELTA

ECONOMIC IMPACT OF HDX THERAPY ENABLED BY THERANOVA DIALYZER IN THE AUSTRALIAN SETTING (ISN-WCN 2025) - "Iron sucrose (PBS code 8807M) [8]...ESA = erythropoiesis stimulating agent. Conclusions HDx therapy enabled by Theranova dialyzer is cost-saving overall in the Australian setting, and presents a practical opportunity to significantly reduce the economic impact of KRT without compromising the delivery of high-quality clinical care."

HEOR • Chronic Kidney Disease • Nephrology • Renal Disease • NOVA2

Real-world safety and effectiveness of sucroferric oxyhydroxide for treatment of hyperphosphataemia in dialysis patients: a prospective observational study. (PubMed, Clin Kidney J) - "SFOH has a favourable safety and tolerability profile in a real-world setting, consistent with results of the Phase 3 study. Moreover, SFOH improved serum phosphorus control with a low daily pill burden."

Clinical • Journal • Observational data • Real-world evidence • Chronic Kidney Disease • Nephrology • Renal Disease

Phosphate Control: The Next Frontier in Dialysis Cardiovascular Mortality. (PubMed, Cardiorenal Med) - "Phosphate retention drives multiple physiological mechanisms linked to increased risk of CVD. Fibroblast growth factor 23 and parathyroid hormone (PTH) levels, both of which have been suggested to have direct pathogenic CV effects, increase in response to phosphate retention. Phosphate, calcium, and PTH levels are linked in a progressively worsening cycle. Maladaptive upregulation of phosphate absorption is also likely to occur further exacerbating hyperphosphatemia. Even higher phosphate levels within the normal range may be a risk factor for vascular calcification and, thus, CV morbidity and mortality. A greater degree of phosphate control is important to reduce the risk of CV morbidity and mortality. Improved phosphate control and regular monitoring of phosphate levels are guideline-recommended, established clinical practices. There are several challenges with the current phosphate management approaches in patients with CKD on dialysis. Dietary restriction of..."

Journal • Review • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Heart Failure • Metabolic Disorders • Nephrology • Renal Disease • FGF23

The Rising Risk of Chronic Kidney Disease (CKD) and How it is Dealt With: A Review of Current and Potential Phosphate Binders (PB). (PubMed, Mini Rev Med Chem) - "Lanthanum carbonate seemed to lower all-cause mortality and reduce the chance of hypercalcemia, even though a deposit in the GI tract was observed. Colestilan, like sevelamer, lowered LDL cholesterol...Bixalomer appeared to have fewer gastrointestinal side effects than sevelamer. Nano-lanthanum hydroxide and SBR759 may have an interesting future as PBs. In conclusion, the development of new PBs should also take into consideration their potential to function as protection modifiers."

Journal • Review • Cardiovascular • Chronic Kidney Disease • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Metabolic Disorders • Nephrology • Renal Disease • FGF23

[VIRTUAL] PHOSPHATE-BINDER THERAPY WITH SUCROFERRIC OXYHYDROXIDE REDUCES ENDOGENOUS CALCIPROTEIN PARTICLE FORMATION AND CRYSTALLIZATION IN A POST-HOC ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL IN DIALYSIS PATIENTS (ERA-EDTA 2021) - "In chronic hemodialysis patients, lowering serum phosphate with SO is associated with a reduction in the load of primary and secondary CPP and a smaller size of secondary CPP."

Clinical • Retrospective data • Cardiovascular • Metabolic Disorders • Nephrology • Renal Disease

[VIRTUAL] JUXTAPOSING THE EFFICACIES BETWEEN IRON-BASED AND NON-CALCIUM PHOSPHATE BINDERS FOR IMPROVING MINERAL AND BONE DISORDER PARAMETERS IN DIALYSIS-DEPENDENT CHRONIC KIDNEY DISEASE PATIENTS: A META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS (ERA-EDTA 2021) - "There is no significant efficacies differences between iron-based and non- calcium phosphate binders for improving serum phosphate, serum calcium ions, iPTH, calcidiol, and calcitriol in dialysis-dependent chronic kidney disease patients, except for the FGF-23 parameter. However, further trials are needed to establish the juxtaposition."

Retrospective data • Chronic Kidney Disease • Metabolic Disorders • Nephrology • Orthopedics • Renal Disease • FGF23

Characterizing Bacterial Cellulose Produced byKomagataeibacter sucrofermentans H-110 on Molasses Medium and Obtaining a Biocomposite Based on It for the Adsorption of Fluoride. (PubMed, Polymers (Basel)) - "The obtained composite material has the highest adsorption capacity of fluoride from water in comparison with other sorbents. The results prove the potential of bacterial cellulose-based biocomposites as highly effective sorbents for fluoride."

Journal

[VIRTUAL] Impact of age on the management of serum phosphorus among hemodialysis (HD) patients prescribed sucroferric oxyhydroxide (SO) as part of routine clinical care (NKF-SCM 2021) - "CONCLUSION Younger HD pts were more likely to have sP >5.5 mg/dl and be prescribed more PB pills/day at BL. Both young and older pts prescribed SO as part of routine care had reductions in sP and PB pill burden, and increases in pts with sP ≤5.5mg/dL."

Clinical

Using iron-based phosphate binders in phosphate reduction and anemia improvement in patients receiving dialysis: a meta-analysis of randomized controlled trials. (PubMed, Int Urol Nephrol) - "FC was associated with the control of hyperphosphatemia and the improvement of anemia. However, PA21 did not show superiority for alleviating anemia compared with the active treatment. Other IBPBs, such as fermagate and SBR759, remained poorly understood due to the limited number of studies. Further trials are required to assess the effect of IBPBs on the risk of cardiovascular events and all-cause mortality."

Journal • Retrospective data • Anemia • Cardiovascular • Hematological Disorders • Metabolic Disorders • Nephrology • Renal Disease

The effect of phosphate binder therapy with sucroferric oxyhydroxide on calcification propensity in chronic haemodialysis patients: a randomized, controlled, crossover trial. (PubMed, Clin Kidney J) - "No major adverse cardiovascular event, case of calciphylaxis or death occurred during the study. Phosphate binder treatment with SO improves serum calcification propensity of haemodialysis patients and might lead to improved outcomes."

Clinical • Journal • Calciphylaxis • Cardiovascular • Chronic Kidney Disease • Nephrology • Rare Diseases • Renal Disease

Real-world management of hyperphosphataemia with sucroferric oxyhydroxide: the VELREAL multicentre study. (PubMed, Clin Kidney J) - "The use of SO in real-life results in better control of serum P, a reduction in the number of tablets and an improvement in therapeutic adherence. In addition, it may be beneficial with regards to secondary hyperparathyroidism and nutritional status."

Clinical • Journal • Real-World Evidence • Endocrine Disorders • Renal Disease • Secondary Hyperparathyroidism

Optimal Phosphate Control Related to Coronary Artery Calcification in Dialysis Patients. (PubMed, J Am Soc Nephrol) - "Further study with a larger sample size is needed, but strict phosphate control shows promise for delaying progression of CAC in patients undergoing maintenance hemodialysis."

Clinical • Journal • Cardiovascular • Metabolic Disorders • Nephrology • Renal Disease

PA21 Safety and Efficacy in Adult Chinese Subjects (clinicaltrials.gov) - P3; N=286; Completed; Sponsor: Vifor Fresenius Medical Care Renal Pharma; Active, not recruiting ➔ Completed

Clinical • Trial completion • Chronic Kidney Disease • Metabolic Disorders • Nephrology • Renal Disease

Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders (clinicaltrials.gov) - P4; N=44; Not yet recruiting; Sponsor: SIGA Technologies; Trial completion date: Dec 2020 ➔ Sep 2022; Initiation date: Dec 2020 ➔ Sep 2021; Trial primary completion date: Dec 2020 ➔ Sep 2022

Clinical • Trial completion date • Trial initiation date • Trial primary completion date

MicrobiomEisen: Velphoro and Impact on the Oral Cavity and Gut Microbiome (clinicaltrials.gov) - P=N/A; N=22; Terminated; Sponsor: RWTH Aachen University; Recruiting ➔ Terminated; Insufficient Patient Recruitment

Trial termination • Metabolic Disorders • Nephrology • Renal Disease

Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients (clinicaltrials.gov) - P4; N=20; Recruiting; Sponsor: University of Colorado, Denver; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Metabolic Disorders • Nephrology • Renal Disease • FGF23

Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders (clinicaltrials.gov) - P4; N=44; Not yet recruiting; Sponsor: SIGA Technologies; Initiation date: Sep 2020 ➔ Dec 2020

Clinical • Trial initiation date

Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders (clinicaltrials.gov) - P4; N=44; Not yet recruiting; Sponsor: SIGA Technologies

Clinical • New P4 trial

PA21 Safety and Efficacy in Adult Chinese Subjects (clinicaltrials.gov) - P3; N=286; Active, not recruiting; Sponsor: Vifor Fresenius Medical Care Renal Pharma; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Chronic Kidney Disease • Nephrology • Renal Disease

VERIFIE: Non-interventional Study to Investigate the Short and Long Term Real-life Safety, Effectiveness, and Adherence of Velphoro® in Patients With Hyperphosphataemia Undergoing Haemodialysis (HD) or Peritoneal Dialysis (PD) (clinicaltrials.gov) - P=N/A; N=1000; Not yet recruiting; Sponsor: Vifor Fresenius Medical Care Renal Pharma

New trial • Biosimilar • Chronic Kidney Disease • Renal Disease

PHARMACOECONOMIC ASSESSMENT OF SUCROFERRIC OXYHYDROXIDE VS SEVELAMER CARBONATE IN PATIENTS WITH CHRONIC KIDNEY DISEASE IN BELGIUM AND THE NETHERLANDS (ISPOR-EU 2017) - "SFOH appears to attain in-range sPhos at a lower cost compared to SEV and may result in additional cost-savings due to less patients switching from oral to costlier IV VDRAs, suggesting favorable cost-effectiveness."

HEOR • Retrospective data • Biosimilar • Chronic Kidney Disease • Renal Disease

Pill Burden and Serum Phosphorus in Hemodialysis Patients Switched from Calcium Acetate to Sucroferric Oxyhydroxide as Part of Routine Care (KIDNEY WEEK 2016) - "Percent of patients achieving sP ≤ 5.5 mg/ dl increased by 32%, 82%, 132% and 113%, comparing CaAc2 to SO1-SO4, respectively. In a cohort of patients switched from CaAc to SO, a >47% reduction in PB pills/day was observed along with improvements in the percent of patients achieving sP ≤ 5.5 mg/dl during SO follow-up."

Retrospective data • Biosimilar

Two Year Follow Up on Chronic Hemodialysis (HD) Patients Prescribed Sucroferric Oxyhydroxide as Part of Routine Care (KIDNEY WEEK 2017) - "During two year follow-up after switching PB to sucroferric oxyhydroxide, patients were 1.9x to 2.7x more likely to have sP ≤ 5.5 mg/dl (95%-179% increase from baseline) while being prescribed 50% less PB pills/day compared to baseline."

Clinical • Renal Disease

Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients (clinicaltrials.gov) - P4; N=20; Not yet recruiting; Sponsor: University of Colorado, Denver; Initiation date: Sep 2019 ➔ Sep 2020

Clinical • Trial initiation date • FGF23

Reversal of vascular disease by regulating magnesium and phosphate Remming van vaatziekte door het regelen van magnesium en fosfaat (clinicaltrialsregister.eu) - P4; N=180; Ongoing; Sponsor: Amsterdam UMC, location VUmc

New P4 trial • FGF23