sevelamer hydrochloride / Generic mfg. - LARVOL DELTA

POPS or POP02: Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) (clinicaltrials.gov) - P=N/A | N=5000 | Recruiting | Sponsor: Duke University | Trial completion date: Jul 2027 ➔ Dec 2026 | Trial primary completion date: Mar 2027 ➔ Nov 2026

Trial completion date • Trial primary completion date • ADHD (Impulsive Aggression) • Asthma • Attention Deficit Hyperactivity Disorder • Bronchopulmonary Dysplasia • Cardiovascular • CNS Disorders • Dermatology • Developmental Disorders • Endocrine Disorders • Genetic Disorders • Gynecology • Heart Failure • Hematological Disorders • Hemophilia • Hypertension • Immunology • Infectious Disease • Insomnia • Metabolic Disorders • Nephrology • Novel Coronavirus Disease • Pain • Pneumonia • Psychiatry • Pulmonary Arterial Hypertension • Pulmonary Disease • Rare Diseases • Renal Disease • Respiratory Diseases • Sleep Disorder

POPS or POP02: Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) (clinicaltrials.gov) - P=N/A | N=5000 | Recruiting | Sponsor: Duke University | Trial primary completion date: Sep 2026 ➔ Mar 2027

Trial primary completion date • ADHD (Impulsive Aggression) • Asthma • Attention Deficit Hyperactivity Disorder • Bronchopulmonary Dysplasia • Cardiovascular • CNS Disorders • Dermatology • Developmental Disorders • Endocrine Disorders • Genetic Disorders • Gynecology • Heart Failure • Hematological Disorders • Hemophilia • Hypertension • Immunology • Infectious Disease • Insomnia • Metabolic Disorders • Nephrology • Novel Coronavirus Disease • Pain • Pneumonia • Psychiatry • Pulmonary Arterial Hypertension • Pulmonary Disease • Rare Diseases • Renal Disease • Respiratory Diseases • Sleep Disorder

Effect of Cinacalcet Combined With Sevelamer Hydrochloride on the Incidence of Urolithiasis in Maintenance Hemodialysis Patients With Diabetic Kidney Disease. (PubMed, Arch Esp Urol) - "Cinacalcet combined with sevelamer hydrochloride can effectively reduce the incidence and recurrence rate of urolithiasis, inhibit stone enlargement and regulate urine pH in patients with diabetic kidney disease undergoing maintenance haemodialysis. It has a positive effect on the prevention and improvement of urolithiasis and can be considered as one of the preferred clinical treatment options for these patients."

Journal • Retrospective data • Chronic Kidney Disease • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Calculi • Renal Disease • Urolithiasis

Sevelamer inhibits the formation of cholesterol gallstones by modulating bile acid metabolism. (PubMed, Front Pharmacol) - "The purpose of this study was to investigate the effect and mechanism of Sevelamer hydrochloride (Sev) on cholesterol gallstone formation via the intestinal Fxr-Fgf15 signaling pathway in a mouse model...Microbiota-bile acid correlation analysis highlighted significant associations between specific taxa and bile acid profiles. Sev might prevent cholesterol gallstone formation by inhibiting the intestinal Fxr-Fgf15 pathway, promoting hepatic bile acid synthesis, reducing biliary cholesterol supersaturation, and restoring gut microbiota balance."

Journal • Gastroenterology

Tenapanor administration combined with phosphate binders provides synergistic phosphate lowering effect (ERA 2025) - "Six types of P binders had been used in Group Ad (sevelamer hydrochloride, bixalomer, calcium carbonate, ferric citrate, sucroferric oxyhydroxide hydrate and lanthanum carbonate hydrate). Oral administration of tenapanor significantly reduced P adsorption and improved serum P level in patients undergoing HD either when it was administrated alone or adding on P binders. This P absorption reduction effect of tenapanor was greatly enhanced when it was added on P binders. The mechanism of this synergistic effect would be an important research question."

Metabolic Disorders • Nephrology • Renal Disease

Gastrointestinal mucosal cell injury caused by sevelamer crystals- Case series and literature review. (PubMed, J Ren Nutr) - "Available in two forms- sevelamer hydrochloride and sevelamer carbonate, it absorbs phosphate in the gastrointestinal tract and is known to have minimal adverse effects. We present a series of two patients with ESKD on sevelamer, with lower gastrointestinal bleeding and endoscopic findings of colonic mucosal injuries with histopathologic findings of sevelamer crystals deposition. Though reported in gastrology literature, nephrology reports show a paucity of discussion around this increasingly common adverse effect and the need for vigilance in ESKD."

Journal • Chronic Kidney Disease • Gastroenterology • Gastrointestinal Disorder • Glomerulonephritis • Metabolic Disorders • Nephrology • Renal Disease

POPS or POP02: Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) (clinicaltrials.gov) - P=N/A | N=5000 | Recruiting | Sponsor: Duke University | Trial completion date: Jul 2024 ➔ Sep 2027 | Trial primary completion date: May 2024 ➔ Sep 2026

Trial completion date • Trial primary completion date • ADHD (Impulsive Aggression) • Asthma • Attention Deficit Hyperactivity Disorder • Bronchopulmonary Dysplasia • Cardiovascular • CNS Disorders • Dermatology • Developmental Disorders • Endocrine Disorders • Genetic Disorders • Gynecology • Heart Failure • Hematological Disorders • Hemophilia • Hypertension • Immunology • Infectious Disease • Insomnia • Metabolic Disorders • Nephrology • Novel Coronavirus Disease • Pain • Pneumonia • Psychiatry • Pulmonary Arterial Hypertension • Pulmonary Disease • Rare Diseases • Renal Disease • Respiratory Diseases • Sleep Disorder

Impact of Sevelamer Hydrochloride on Fibroblast Growth Factor-23 Levels in Patients Undergoing Hemodialysis (ERA-EDTA 2024) - "We aimed to Assessing the Impact of Sevelamer Carbonate on Fibroblast Growth Factor-23 Levels. This study found that non-calcium-based phosphate binders were associated with a substantial reduction in FGF-23 in hemodialysis patients. This finding suggests that utilizing such binders may offer protection against the adverse effects of high FGF-23 levels, which are prevalent in this population."

Clinical • Cardiovascular • Chronic Kidney Disease • Nephrology • Renal Disease • CRP • FGF23

Can Oral Phosphate Binders Be Added to Dialysate to Improve the Efficacy of Hemodialysis? (KIDNEY WEEK 2023) - "It is a buffered form of Sevelamer hydrochloride. This is an in-vitro hemodialysis experiment using 1 liter of freshly collected Li-heparinized porcine blood with an average blood flow rate of 30 mL/min and dialysate flow of 50 mL/min, two peristaltic pumps, Fresenius Optiflux hemodialysis membranes, and CitraPure dialysate concentrate (Rockwell Medical) which was diluted and the pH adjusted using sodium bicarbonate (Solcart B, B.Braun). The addition of Sevelamer Carbonate (SC) effectively lowered phosphate using recirculated dialysate and can be incorporated into a novel hemodialysis machine that can recirculate dialysate, reducing water consumption for both in-center and home hemodialysis. While SC effectively reduced phosphate levels, its addition to the dialysate has been found to influence the dialysate pH. Therefore, careful consideration must be given to pH adjustment when utilizing SC."

Clinical • Metabolic Disorders • Nephrology • Renal Disease

Elderly-onset calcinosis of hyperphosphataemic familial tumoural calcinosis/hyperostosis-hyperphosphataemia syndrome: the role of comorbid scleroderma. (PubMed, Endocrinol Diabetes Metab Case Rep) - "A low phosphate diet was prescribed with phosphate-lowering medications, including aluminium hydroxide, acetazolamide, and sevelamer hydrochloride. HFTC/HHS may be undiagnosed until later in life because of its rarity, unfamiliarity, and phenotype diversity; therefore, HFTC/HHS should be included in the differential diagnosis of elderly patients with unexplained hyperphosphataemia or ectopic calcinosis. Comorbidities, including rheumatologic disorders, may contribute to developing HFTC/HHS-associated calcinosis."

Journal • Diabetes • Fibrosis • Hematological Disorders • Immunology • Metabolic Disorders • Oncology • Renal Disease • Rheumatology • Scleroderma • Systemic Sclerosis • Type 2 Diabetes Mellitus • FGF23

Biochemical markers of iron status and iron accumulation in peritoneal dialysis patients treated with ferric citrate. (PubMed, Perit Dial Int) - "Treatment options include calcium carbonate, calcium acetate, lanthanum carbonate, sevelamer hydrochloride and iron-based binders. Two patients (7%) treated with ferric citrate developed clinically significant haemosiderosis. Use of ferric citrated in PD resulted in significant iron accumulation as judged by ferritin levels."

Journal • Hematological Disorders • Nephrology • Renal Disease • Transplantation

THE COURSE OF OSTEODYSTROPHY IN PATIENTS WITH STAGE 5 CHRONIC KIDNEY DISEASE RECEIVING PROGRAMMED HEMODIALYSIS (ERA-EDTA 2023) - "In patients with CKD, against the background of programmed hemodialysis, there is a decrease in bone mineral density (1.93 times the bodies of the lumbar vertebrae and 2.83 times the femoral neck). The use of calcium carbonate, biphosphonate and vitamin D3 contributes to an increase in the mineral density of the femoral neck by 8.64% (p<0.05). The introduction of sevelamer hydrochloride into the therapy regimen increases the effectiveness of therapy and increases the mineral density of the bodies of the lumbar vertebrae by 5.96% (p< 0.05) and the femoral neck by 14.04% (p<0.05)."

Clinical • Anemia • Chronic Kidney Disease • Endocrine Disorders • Glomerulonephritis • Hematological Disorders • Lupus Nephritis • Nephrology • Osteoporosis • Renal Disease • Rheumatology • Secondary Hyperparathyroidism

ASSESSMENT OF EXTRA-BONE CALCIFICATION IN PATIENTS UNDERGOING PROGRAMMED HEMODIALYSIS (ERA-EDTA 2023) - "In patients with CKD, against the background of programmed hemodialysis, there is a remodeling of the heart with an increase in the size of the heart cavities and LV myocardial mass, a violation of regional and general LV contractile function, LV diastolic dysfunction and an increase in pressure in the pulmonary artery system. The introduction of sevelamer hydrochloride into the therapy regimen is associated with the prevention of the progression of cardiac remodeling. Calcification of the aortic valve progresses, regardless of the therapy used."

Clinical • Cardiovascular • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Renal Disease • Secondary Hyperparathyroidism

Repurposing of sevelamer as a novel antidote against aluminum phosphide poisoning: An in vivo evaluation. (PubMed, Heliyon) - "Sevelamer carbonate or sevelamer hydrochloride (Renagel) is a polymeric pharmaceutical prescribed for treating hyperphosphatemia in patients with chronic kidney disease. The results showed that sevelamer could be a potent antidote for managing aluminum phosphide poisoning. Moreover, a mechanism is suggested for the interaction of sevelamer with phosphine gas."

Journal • Preclinical • Chronic Kidney Disease • Metabolic Disorders • Nephrology • Renal Disease

Real-World Phosphate Binder Use Among Dialysis-Dependent Patients With CKD. (PubMed, Nephron) - "Adherence and persistence rates were low with slight variation across PBs. Net positive switching occurred for ferric citrate, sucroferric oxyhydroxide, and lanthanum carbonate. Further studies are needed to determine the reasons for these findings and could identify opportunities for better control of phosphate levels among patients with CKD."

Journal • Real-world • Real-world evidence • Chronic Kidney Disease • Nephrology • Renal Disease

Gastrointestinal Injury in Patients with Chronic Kidney Disease is Unlikely to Result from Sevelamer Use (USCAP 2023) - "Background : Sevelamer hydrochloride is used to treat hyperphosphatemia in chronic kidney disease (CKD) patients and is implicated in gastrointestinal (GI) injury... GI injury in CKD patients has similar features regardless of the presence of sevelamer, supporting the notion that the resin adheres to rather than causes tissue injury. Our study highlights other histologically identifiable causes of intestinal injury, as well as injury unassociated with sevelamer in patients known to be taking the drug. Pathologists and clinicians should be cautious in attributing GI symptoms to sevelamer so as not to overlook other clinically actionable disorders."

Clinical • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Cytomegalovirus Infection • Dermatology • Diabetes • Gastrointestinal Disorder • Heart Failure • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Hypertension • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Lupus • Metabolic Disorders • Nephrology • Pain • Renal Disease • Septic Shock • Systemic Lupus Erythematosus • Vasculitis

Gastrointestinal Injury in Patients with Chronic Kidney Disease is Unlikely to Result from Sevelamer Use (USCAP 2023) - "Background : Sevelamer hydrochloride is used to treat hyperphosphatemia in chronic kidney disease (CKD) patients and is implicated in gastrointestinal (GI) injury... GI injury in CKD patients has similar features regardless of the presence of sevelamer, supporting the notion that the resin adheres to rather than causes tissue injury. Our study highlights other histologically identifiable causes of intestinal injury, as well as injury unassociated with sevelamer in patients known to be taking the drug. Pathologists and clinicians should be cautious in attributing GI symptoms to sevelamer so as not to overlook other clinically actionable disorders."

Clinical • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Cytomegalovirus Infection • Dermatology • Diabetes • Gastrointestinal Disorder • Heart Failure • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Hypertension • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Lupus • Metabolic Disorders • Nephrology • Pain • Renal Disease • Septic Shock • Systemic Lupus Erythematosus • Vasculitis

Effect of guanidinium content on the anion binding capacity of polyallylamine-based polymer networks (ACS-Sp 2023) - "The starting point was the phosphate-binding drug sevelamer hydrochloride, a polymer of allylamine used to treat hyperphosphatemia in chronic kidney disease...Lastly, a colorimetric enzyme-based assay is being used to study bile acid absorption by the polymers, but these studies are still in progress. Overall, these results will inform future design of polymer resins for treatment of medical conditions and environmental remediation."

Chronic Kidney Disease • Metabolic Disorders • Nephrology • Renal Disease

A Retrospective Single-Center Study of Sevelamer Hydrochloride for the Treatment of Hyperphosphatemia in Children With Tumor Lysis Syndrome. (PubMed, Cureus) - "This finding further consolidates the efficacy of sevelamer in treating hyperphosphatemia with TLS. However, further research into the drug's kinetics is recommended."

Journal • Retrospective data • Chronic Kidney Disease • Hematological Disorders • Hematological Malignancies • Metabolic Disorders • Nephrology • Oncology • Renal Disease

Gastrointestinal Tract Injuries Associated With Sevelamer: A Systematic Review (ACG 2022) - "We included 58 studies describing a total of 77 patients with a mean age of 58.8 years. Diabetes was present in 27% of cases and at least one risk factor to have slow GIT motility was identified in 63.3% of patients. Both sevelamer carbonate and sevelamer hydrochloride were reported to be associated with GIT injury."

Review • Cardiovascular • Chronic Kidney Disease • Constipation • Diabetes • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Metabolic Disorders • Nephrology • Pain • Renal Disease

Enhancing the Phosphate Adsorption of a Polyallylamine Resin in Alkaline Environments by Lanthanum Oxalate Modification. (PubMed, ACS Omega) - "Sevelamer hydrochloride (SH), originally developed as an oral pharmaceutical for controlling blood phosphate levels, is a polyallylamine resin that could be used in water treatments...Both factors lead to the improved adsorption properties. The modification by lanthanum oxalate species might provide a new alternative for improving the phosphate adsorption properties of anion-exchange resins."

Journal

In vitro cytogenetic analysis of two different anti-phosphates (sevelamer hydrochloride and calcium carbonate) agents used by patients with hyperphosphatemia. (PubMed, Drug Chem Toxicol) - "Both test substances, particularly SH, significantly reduced the nuclear division index compared to the control group. In conclusion, the cytotoxic effect of SH was evident on the basis of in vitro tests and slightly higher than CaCO."

Journal • Preclinical • Metabolic Disorders • Nephrology • Renal Disease

The influence of poly(allylamine hydrochloride) hydrogel crosslinking density on its thermal and phosphate binding properties. (PubMed, Int J Pharm) - "However, the influence of the pH of the binding media on the binding parameters of sevelamer hydrochloride was significant. This is the first report on the use of AD spectra generated from L-FI binding parameters in hydrogels, which demonstrates the sensitivity of the affinity and binding site numbers to changes in hydrogel physical properties and the pH of the binding media."

Journal • Chronic Kidney Disease • Nephrology • Renal Disease

Real-World Adherence and Persistence on Phosphate Binders Among Dialysis-Dependent Patients With Chronic Kidney Disease (NKF-SCM 2022) - "We assessed monthly PB use for calcium acetate, ferric citrate, lanthanum carbonate, sevelamer (hydrochloride and carbonate), and sucroferric oxyhydroxide. Further studies are needed to determine the reasons for these findings on use of PB and its variation across different binders within the class. These studies could identify opportunities for better control of phosphate levels among patients with CKD."

Clinical • HEOR • Real-world evidence • Chronic Kidney Disease • Nephrology • Renal Disease

Real-World All-Cause Healthcare Costs Among Dialysis-Dependent Patients With Chronic Kidney Disease on Phosphate Binders (NKF-SCM 2022) - "We assessed monthly PB use for calcium acetate, ferric citrate, lanthanum carbonate, sevelamer (hydrochloride and carbonate), and sucroferric oxyhydroxide. Further studies are needed to determine if healthcare utilization and outcomes, particularly for services in the CMS ESRD bundle, also vary. These studies could identify opportunities for better control of phosphate levels among patients with CKD."

Clinical • HEOR • Real-world evidence • Chronic Kidney Disease • Metabolic Disorders • Nephrology • Renal Disease