sevelamer carbonate / Generic mfg. - LARVOL DELTA

AP301 Efficacy and Safety in Chinese Dialysis Patients With Hyperphosphatemia (clinicaltrials.gov) - P3 | N=474 | Completed | Sponsor: Alebund Pharmaceuticals

New P3 trial • Chronic Kidney Disease • Metabolic Disorders • Nephrology • Renal Disease

Management of Resistant Hyperphosphatemia in Maintenance Hemodialysis (MHD) patients - Role of Sucroferric Oxyhydroxide (SFO): A prospective study (ERA 2025) - "Background and Aims:Hyperphosphatemia is common in advanced CKD and is associated with increased cardiovascular morbidity, bone mineral abnormalities and mortality. SFO demonstrated superior efficacy in reducing serum phosphorus levels in MHD patients who previously failed to achieve phosphorus control with sevelamer carbonate in tolerated doses. SFO offered a better phosphorus control (p = 0.03), numerically lower mean daily pill burden (p = 0.02), lower treatment cost and a better treatment adherence than sevelamer carbonate. These findings strongly support the use of SFO as first line hyperphosphatemic patients with advanced CKD to improve phosphorus control, patient longevity and Quality of life."

Clinical • Cardiovascular • Chronic Kidney Disease • Metabolic Disorders • Nephrology • Renal Disease

Gastric Mucosal Calcinosis Case Study: A Diagnosis to Consider in People with Kidney Failure and Gastrointestinal Symptoms? (UKKW 2025) - "Relevant medication history: alfacalcidol (250-500ng daily), cholecalciferol (60,000units fortnightly), cinacalcet (changed to Etelcalcitide 2024), lanthanum carbonate (stopped in 2023), sevelamer carbonate (2023-present). There is no prevalence, or outcome, data reported for gastric mucosal calcinosis; it may be underdiagnosed. The calciphylaxis rare disease registry, and UK renal registry, may offer an opportunity to undertake research to better understand the disease process, risk factors and prevalence."

Case study • Clinical • Anorexia • Calciphylaxis • Chronic Kidney Disease • Endocrine Disorders • Gastroenterology • Glomerulonephritis • IgA Nephropathy • Metabolic Disorders • Nephrology • Oncology • Pain • Rare Diseases • Renal Disease • Secondary Hyperparathyroidism

The Impact of Dairy Dietary Phosphorus on Carbohydrate Metabolism in Healthy Individuals (ECO 2025) - "Sevelamer carbonate (Renvela), an orally administered pharmaceutical, widely approved for the treatment of hyperphosphatemia in patients living with end-stage renal disease, was used for phosphate binding... By chelating P and preventing its absorption, our findings demonstrate a clear, independent inverse association between dietary P and post prandial glucose levels; indicating that the glycemic benefits of milk - previously ascribed to their protein content - may be confounding the favorable glycemic role of P. Furthermore, results of this study put emphasis on the importance of maintaining optimal P intake levels, which may potentially contribute to the prevention and management of insulin resistance, obesity, and other co-related components of the metabolic syndrome. Conflict of Interest: None disclosed. Funding: No funding to report."

Clinical • Genetic Disorders • Metabolic Disorders • Nephrology • Obesity • Renal Disease

Correlation between parathyroid volume and calcium and phosphorus metabolism in maintenance hemodialysis patients based on Doppler ultrasound technology. (PubMed, Int Urol Nephrol) - "A significant linear correlation was observed between PTGs volume, assessed via Doppler ultrasound, and the variables of age, albumin, iPTH, and corrected serum calcium in MHD patients. Therefore, it is essential for MHD patients to be closely monitored and have these serological indices controlled."

Journal • Endocrine Disorders • Renal Disease • Secondary Hyperparathyroidism

A Pan-Inhibitor of Phosphate Transporters AP306 in Hemodialysis Patients. (PubMed, Kidney Int Rep) - "In this phase 2 randomized, active-controlled, open-label study, hemodialysis patients with serum phosphate between 5.5 and 9.0 mg/dl were randomized to receive either AP306 or sevelamer carbonate for 12 weeks...AP306 monotherapy significantly reduced serum phosphate levels and substantially improved the serum phosphate control rate in hemodialysis patients with hyperphosphatemia. AP306 was safe and well-tolerated."

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

The effects of resins added to the milk of children suffering from chronic kidney disease: a clinical relevance to control potassium and phosphate levels? (PubMed, Nephrol Ther) - "We added either carbonate sevelamer (Renvela®, 200, 400 or 800 mg) or polystyrene sulfonate (Resikali®, 2000, 4000 or 8000 mg) to 90 ml of formula...Pretreating formulas with resins is a reproducible and straightforward method when specific diets for CKD are unavailable. However, it is important to keep in mind that resins may impact the overall composition (osmolality) and the concentration of other nutrients (folates)."

Journal • Chronic Kidney Disease • Metabolic Disorders • Nephrology • Pediatrics • 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

Multifaceted skeletal effects of sevelamer carbonate in a secondary hyperparathyroidism model. (PubMed, Endocrine) - "These findings in CKD-SHPT rats suggest that SevC improves bone mechanical properties at various levels by decreasing serum pyrophosphate, empty lacunae, and enhancing renal clearance of indole acetic acid, organized mineral-matrix deposition, and osteocyte number by suppressing cortical remodeling."

Journal • Chronic Kidney Disease • Endocrine Disorders • Gastrointestinal Disorder • Metabolic Disorders • Musculoskeletal Diseases • Nephrology • Orthopedics • Renal Disease • Secondary Hyperparathyroidism • FGF23

Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Jemincare | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Metabolic Disorders • Nephrology • Renal Disease

Severe acute kidney injury with suspected bilateral renal artery stenosis on renal Duplex while on concurrent ACE inhibition – A case for carbon dioxide renal angiography (ISN-WCN 2025) - "Lisinopril, Hydrochlorothiazide and Rosuvastatin were promptly discontinued...He also received 3 doses of oral sodium Zirconium cyclosilicate, 10 gm, repeated every 6 hours...He was started on Sevelamer carbonate, taken TID with meals, for hyperphosphatemia and was maintained on a renal diet...We posit that this was a clear medical indication for non-nephrotoxic carbon dioxide angiography. We plan to repeat the renal artery Duplex in the near future."

Clinical • Acute Kidney Injury • Cardiovascular • Cough • Dyslipidemia • Fatigue • Glomerulonephritis • Hematological Disorders • Hepatology • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Inflammation • Metabolic Disorders • Nephrology • Pneumonia • Renal Disease • Respiratory Diseases • Thrombosis

The effect of sevelamer on serum calcification propensity in patients with chronic kidney disease: the results of a multicentre, double-blind, placebo-controlled, randomized clinical trial. (PubMed, Clin Kidney J) - "A 12-week course of the non-calcium-containing phosphate binder sevelamer carbonate was not associated with a significant change in T50 in patients with stage 3b/4 CKD. Phosphate binders might not be an effective strategy for modifying serum calcification propensity in non-dialysis-dependent patients with CKD."

Clinical • Journal • Chronic Kidney Disease • Nephrology • Renal Disease • FGF23

Bound for Trouble: Acute Sevelamer-Induced GI Bleeding in a Non-CKD Patient (ACG 2024) - "Two days later, patient was started on sevelamer carbonate 1,600 mg TID with meals due to phosphorus values up to 7.5 mg/dL...Caution should be exercised when deciding the dose of sevelamer in an acutely ill patient, and prompt cessation of the drug should be considered in patients taking sevelamer who present with similar symptoms. Figure: Cecal ulcer"

Clinical • Cardiovascular • Chronic Kidney Disease • Chronic Obstructive Pulmonary Disease • Gastrointestinal Disorder • Hematological Disorders • Immunology • Infectious Disease • Influenza • Metabolic Disorders • Nephrology • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Sevelamer-Associated Colitis: A Case Study in a Patient With Suspected Colonic Mass (ACG 2024) - " Sevelamer carbonate has been used to treat hyperphosphatemia in chronic kidney disease since 2000...Gastroenterologists should consider sevelamer-induced mucosal injury in their differential diagnosis for patients with relevant symptoms. Figure: Biopsy of the cecal mass revealed fragments of pill material consistent with sevelamer, which were found within the ulcer fibrinopurulent debris."

Case study • Clinical • Anemia • Chronic Kidney Disease • Dyspepsia • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Hematological Disorders • Hypotension • Immunology • Metabolic Disorders • Nephrology • Oncology • Pain • Renal Disease

Impact of Phosphate Binders on Bone Protein Expression in Rats Fed Diets with Different Phosphorus Concentrations (KIDNEY WEEK 2024) - "This study evaluated the efficacy of calcium carbonate (CaCO3) and sevelamer carbonate (Sev) on the bone expression of proteins involved in the Wnt/β-catenin pathway in nephrectomized (Nx) and parathyroidectomized (PTx) rats fed normal and high P diets. Wistar rats underwent 5/6 nephrectomy (Nx), parathyroidectomy (PTx), and were fed diets with different P concentrations (0.6% and 1.2%)... Our results showed that treatment with both binders was effective in decreasing serum P and fractional excretion and increasing Cai. Phosphate overload increased FGF23 expression in the bone, and both binders were effective in reducing this expression. The Wnt/β-catenin pathway was blocked by sclerostin, with higher expression in animals with P overload, and both treatments reduced its expression, which was also observed in gene expression."

Preclinical • Cardiovascular • Chronic Kidney Disease • Metabolic Disorders • Nephrology • DKK1 • FGF23 • SOST

Impact of Phosphate Binders on Bone Histomorphometry in Rats Submitted to Diets with Different Concentrations of Phosphorus (KIDNEY WEEK 2024) - "This study evaluated the impact of calcium carbonate (CaCO3) and sevelamer carbonate (Sev) on bone tissue in nephrectomized (Nx) and parathyroidectomized (PTx) rats fed normal and high-phosphorus diets. Wistar rats underwent 5/6 nephrectomy (Nx) and parathyroidectomy (PTx) and were fed diets with different P concentrations (0.6% and 1.2%)... Our results demonstrated that, although CaCO3 was effective in reducing serum P, it significantly altered bone formation and resorption parameters, possibly due to calcium overload. In contrast, the use of sevelamer did not alter bone parameters. These findings reinforce the importance of considering the side effects related to calcium load when choosing phosphate binders."

Preclinical • Cardiovascular • Chronic Kidney Disease • Metabolic Disorders • Nephrology

Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Jemincare

New P2 trial • Chronic Kidney Disease • Metabolic Disorders • Nephrology • Renal Disease

Efficacy and safety of sucroferric oxyhydroxide versus sevelamer carbonate: A systematic review and meta-analysis. (PubMed, Hemodial Int) - "This meta-analysis of randomized trials showed that both drugs, sucroferric oxyhydroxide and sevelamer equally and effectively controlled serum phosphorus levels, whereas sucroferric oxyhydroxide revealed a better profile in terms of gastrointestinal adverse events. Sucroferric oxyhydroxide is a valuable option for patients receiving KRT when sevelamer carbonate is more difficult to tolerate."

Clinical • Journal • Retrospective data • Review • Chronic Kidney Disease • Gastrointestinal Disorder • Nephrology • Orthopedics • Renal Disease

Exploring the top 30 drugs associated with drug-induced constipation based on the FDA adverse event reporting system. (PubMed, Front Pharmacol) - "The drug with the highest ranking was lenalidomide (7,730 cases, 4.55%), with the most prevalent drug class being antineoplastic and immunomodulating agents...However, four drugs (orlistat, nintedanib, palbociclib, and dimethyl fumarate) presented an unexpected risk of constipation. Ranked by signal values, sevelamer carbonate emerged as the drug with the strongest risk signal [reporting odds ratio (95% CI): 115.51 (110.14, 121.15); PRR (χ2): 83.78 (191,709.73); EBGM (EB05): 82.63 (79.4); IC (IC025): 6.37 (4.70)]...The median TTO for orlistat was 3 days, the shortest of all the drugs, while the median TTO for clozapine was 1,065 days, the longest of all the drugs. Our study provides a list of drugs potentially associated with drug-induced constipation (DIC). This could potentially inform clinicians about some alternative medications to consider when managing secondary causes of constipation or caring for patients prone to DIC, thereby reducing the incidence and..."

Adverse events • Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology

In a Bind (KIDNEY WEEK 2024) - "She developed hyperphosphatemia (peak phosphorus level of 7.5 mg/dL) which was treated with 1,600mg oral Sevelamer carbonate 3x daily...Figure 1. Sevelamer-associated colonic ulcer in the setting of an AKI demonstrating characteristic "tree bark" appearance.."

Acute Kidney Injury • Endocrine Disorders • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Infectious Disease • Influenza • Metabolic Disorders • Nephrology • Renal Disease • Respiratory Diseases

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

A case report of sevelamer crystals associated recto-sigmoid ulcers: An unusual side effect (UKKW 2024) - "Sevelamer carbonate is a phosphate binder used to manage hyperphosphatemia in CKD patients, approved in 2000 [1]...Unfortunately, there is no literature available on strategies to prevent sevelamer-induced mucosal injury. Nephrologists, gastroenterologists, and pathologists must be knowledgeable about the morphological features of the drug to accurately diagnose and prevent severe complications associated with mucosal injury."

Adverse events • Case report • Clinical • Chronic Kidney Disease • Gastroenterology • Gastrointestinal Disorder • Inflammation • Metabolic Disorders • Nephrology • Orthopedics • Pain • Renal Disease

A Phase 2 Trial to Evaluate Serum Phosphate Lowering Effect of a Pan-phosphate Transporter Inhibitor AP306 in Dialysis Patients with Hyperphosphatemia (ERA-EDTA 2024) - P2 | "AP306 (formerly known as EOS789) is an oral pan-inhibitor of phosphate transporters, including NaPi-2b, PiT-1, and PiT-2, which is designed to block the active uptake of phosphate through the gastrointestinal tract...The patients undergoing stable hemodialysis were randomized in a 1:1 ratio to receive AP306 or the active comparator, sevelamer carbonate, if their serum phosphorus was between 5.5 and 9.0 mg/dL after a wash-out period... AP306 monotherapy significantly reduced serum phosphorus with clinical significance and substantially improved the control rate in hemodialysis patients with hyperphosphatemia. AP306 was safe and well-tolerated."

Clinical • Late-breaking abstract • P2 data • Chronic Kidney Disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Metabolic Disorders • Nephrology • Renal Disease • SLC34A2

Efficacy and safety of sucroferric oxyhydroxide versus sevelamer carbonate: a systematic review and meta-analysis (ERA-EDTA 2024) - "This meta-analysis found that sucroferric oxyhydroxide and sevelamer carbonate are equally effective in controlling serum phosphorus and i-PTH levels. Sucroferric oxyhydroxide, however, demonstrated a more favorable profile regarding gastrointestinal adverse events. Our findings suggest sucroferric oxyhydroxide as a valuable alternative for RRT patients who have difficulty tolerating sevelamer carbonate."

Retrospective data • Review • Atherosclerosis • Cardiovascular • Chronic Kidney Disease • Dyslipidemia • Gastrointestinal Disorder • Hypertension • Metabolic Disorders • Nephrology • Renal Disease

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