sevelamer carbonate / Generic mfg. - LARVOL DELTA

Sevelamer carbonate crystal associated colitis in a hemodialysis patient: a case report. (PubMed, Oxf Med Case Reports) - "Sevelamer carbonate was discontinued with subsequent clinical improvement. This case highlights a clinically important diagnostic pitfall in resource-limited settings where amebic colitis is endemic and empiric metronidazole is commonly the first-line response to chronic diarrhea in dialysis patients."

Journal • Chronic Kidney Disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Nephrology • Pain • Renal Disease

Efficacy and safety of ferric citrate tablets in Chinese patients with hyperphosphatemia undergoing maintenance hemodialysis: a multicenter, randomized, open-label, active-controlled, phase III trial. (PubMed, Ren Fail) - "Most treatment-emergent adverse events were mild, with gastrointestinal disorders being the most common. Ferric citrate tablets were non-inferior to sevelamer carbonate in reducing serum phosphorus levels in hyperphosphatemia patients on maintenance hemodialysis, with the added benefit of improving iron-related anemia and a favorable safety profile."

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

A Rare Cause of âFish-Scaleâ Colitis Mimicking Ischemic Injury (ACG 2026) - "Case Description/ A 65-year-old woman with ESRD managed with peritoneal dialysis and sevelamer carbonate presented with chest pain, nausea, and vomiting...Ulceration of the colonic mucosa Figure: Image 2. Fish Scale Crystals on Histologic Evaluation"

Cardiomyopathy • Cardiovascular • Chronic Kidney Disease • Cognitive Disorders • Congestive Heart Failure • Gastroenterology • Gastrointestinal Disorder • Heart Failure • Hypotension • Immunology • Inflammatory Bowel Disease • 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 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

Clinical Evaluation of Low-Dose Magnesium Carbonate as a Phosphate Binder in Chronic Hemodialysis Patients. (PubMed, Life (Basel)) - " The phosphorus-lowering potential of low-dose magnesium carbonate is non-inferior to that of low-dose sevelamer carbonate. However, its favorable safety profile, low incidence of adverse effects, and cost-effectiveness make it a promising option in clinical practice, further highlighting the need for better recognition by physicians."

Journal • Cardiovascular • Chronic Kidney Disease • Metabolic Disorders • Nephrology • Orthopedics • Renal Disease

Recurrent Calciphylaxis With Discordant Parathyroid Hormone Trajectory in a Patient With HIV-Associated End-Stage Renal Disease: A Case Report. (PubMed, Cureus) - "At initial presentation (T1), intact parathyroid hormone (iPTH) was 806.5 pg/mL; she was treated with paricalcitol, sevelamer carbonate, and intravenous sodium thiosulfate (STS) but remained intermittently nonadherent to hemodialysis and prescribed therapies, with a single-pool Kt/V of 0.29 documented at recurrence. Parathyroidectomy was deferred at T2 and T3 because of acute infectious burden and uncontrolled hyperkalemia, respectively. This case illustrates the diagnostic and management complexity of recurrent calciphylaxis in HIV-associated ESRD, demonstrates how intermittent treatment adherence may produce highly discordant iPTH measurements that complicate threshold-based monitoring, and underscores the importance of multidisciplinary planning before surgical and metabolic barriers to parathyroidectomy accumulate."

Journal • Calciphylaxis • Cardiovascular • Chronic Kidney Disease • Endocrine Disorders • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Metabolic Disorders • Nephrology • Rare Diseases • Renal Disease • CD4

Novel therapeutic approaches for phosphate regulation. (PubMed, Curr Opin Nephrol Hypertens) - "Combining phosphate binders with agents that inhibit paracellular and transcellular intestinal phosphate absorption may improve the treatment of hyperphosphatemia while reducing pill burden in CKD. Defining optimal serum phosphate targets and the mortality benefits of phosphate lowering is essential to minimize treatment-related adverse effects."

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

Watch Out For Phosphate Binders: Colonic Necrosis In A 58YearOld Female With Newly Diagnosed EndStage Renal Disease (ASCRS 2026) - "Sevelamer carbonate, a non-absorbable phosphate binder commonly prescribed for advanced kidney disease, is generally considered safe...This report describes a case of extensive colonic necrosis associated with sevelamer initiation in a patient with newly diagnosed ESRD.Methods/Interventions: A 58-year-old female with a history of daily tobacco and methamphetamine use and untreated atrial fibrillation presented with weakness, dyspnea, and chronic cough...This case emphasizes the need for vigilance among clinicians, thorough evaluation of GI symptoms in patients prescribed sevelamer, and the importance of early pathological confirmation to guide timely management.Sevelamer crystals present within the colonic tissue demonstrating the fish scale appearance This image visualizes the sevelamer crystals that were deposited into the lining of the colon leading to transmural colonic necrosis. Ischemic necrosis of the colonThis image depicts the pathological changes within the..."

Acute Kidney Injury • Atrial Fibrillation • Cardiovascular • Chronic Cough • Chronic Kidney Disease • Cough • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Nephrology • Pulmonary Disease • 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 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

Calcium-Based Phosphate Binder Induces Osteomalacia in a Rat Model of Adynamic Bone Disease. (PubMed, Calcif Tissue Int) - "This study evaluates the effects of two P binders-calcium carbonate (CaCO₃) and sevelamer carbonate-on laboratorial markers and bone histomorphometry in a low-turnover bone disease model...Notably, CaCO₃ treatment led to increased osteoid parameters, elevated osteoblast surface and absence of tetracycline labeling - hallmarks of osteomalacia...In a rat model of low-turnover bone disease with normal dietary P, high-dose CaCO₃ impaired bone mineralization and induced osteomalacia. These findings highlight potential risks of calcium-based phosphate binders in patients with low bone turnover and hyperphosphatemia, supporting the need for careful clinical consideration and monitoring."

Journal • Preclinical • Chronic Kidney Disease • Endocrine Disorders • Metabolic Disorders • Nephrology • Orthopedics • Renal Disease • CTNNB1 • DKK1 • FGF23 • SOST

52-Week Phase 3 Study to Evaluate the Efficacy and Safety of a Novel Iron-Based Phosphate Binder AP301 in Patients on Dialysis with Hyperphosphatemia (KIDNEY WEEK 2025) - P3 | "Methods In this active controlled study (NCT07030595), hemo- and peritoneal dialysis patients with baseline serum phosphate (s-P) 6.0-10.0 mg/dL were randomized 3:1 to AP301 (2.1–9.1 g/d) or sevelamer carbonate (SEV) (2.4–9.6 g/d); doses were given TID with meals, titrated to keep s-P 3.5-5.5 mg/dL...Mild, non-clinical meaningful changes of iron parameters were observed through Week 24, with no evidence of iron accumulation. Conclusion This novel iron-based phosphate binder AP301 effectively lowered s-P in dialysis patients with an acceptable safety and tolerability profile."

Clinical • Late-breaking abstract • P3 data • Constipation • Gastroenterology • Gastrointestinal Disorder • Metabolic Disorders • Nephrology • Renal Disease

Oxylanthanum Carbonate Achieves Serum Phosphate Control with Significantly Lower Pill Burden in Patients with Hyperphosphatemia on Dialysis (KIDNEY WEEK 2025) - "Pretrial PB included sevelamer carbonate, calcium acetate, ferric citrate, and sucroferric oxyhydroxide. Combined with previously presented safety data, these findings suggest that OLC is safe, effective, and well-tolerated. Its small, easy-to-swallow formulation may be a welcome choice for pts with HP."

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

Rectal Sevelamer Deposits: An Irritant Causing Recurrent Lower Gastrointestinal Bleeds (ACG 2025) - "Introduction: Sevelamer carbonate is a non-absorbable phosphate-binding resin that is used to treat hyperphosphatemia in patients with chronic kidney disease...The patient's Sevelamer was discontinued and she was started on rectal sucralfate enemas along with sennosides ultimately resulting in resolution of her lower gastrointestinal bleed (GIB). Although a retrospective analysis of patients on HD has found no significantly increased risk of GIB in patients started on Sevelamer compared to non-Sevelamer phosphate binders, several individual cases of GIB have identified Sevelamer deposits in biopsied lesions. Our case suggests that rather than being the cause of GIB, Sevelamer deposition may aggregate at sites of mucosal erosion and cause recurrent bleeds in predisposed individuals. Further correlative evidence and systematic reviews are necessary to explore the exact role of Sevelamer in causing GIB.Figure: Figure 1: View on colonoscopy and flexible sigmoidoscopy of..."

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

Crystalline Colitis: A Rare Adverse Effect of Sevelamer Therapy (ACG 2025) - "Home medications included sevelamer carbonate dosed at 2400mg three times daily...Given the presence of sevelamer crystals, the medication was discontinued and replaced with lanthanum carbonate. Sevelamer-induced colitis should be considered in dialysis patients presenting with unexplained colitis, especially when infectious and ischemic causes have been ruled out...Delayed recognition may lead to unnecessary treatments, prolonged symptoms, and increased morbidity. Early identification and discontinuation of sevelamer, with substitution by an alternative phosphate binder, are essential for symptom resolution and prevention of further gastrointestinal injury.Figure: Images A, B, C: Diffuse, severe inflammation found in the proximal transverse colon during colonoscopy."

Adverse events • Atrial Fibrillation • Cardiovascular • Chronic Kidney Disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Nephrology • Renal Disease

AN ATYPICAL CASE OF HEMOPTYSIS DUE TO BRONCHIAL PETECHIAE FROM ESCITALOPRAM USE (CHEST 2025) - "Outpatient medications include amlodipine, losartan, levothyroxine, furosemide, omeprazole, pravastatin, sodium bicarbonate, sevelamer carbonate, and escitalopram...The patient was initiated on empiric ceftriaxone and doxycycline...The patient's hemoptysis had resolved at this time and was discharged with Amoxicillin/ Clavulanate for a total course of seven days... When evaluating patients with hemoptysis with diffuse bronchial petechiae, it is imperative to consider potential offending medications through comprehensive medication reconciliation if no clear causative etiology is identified. SSRIs have common side effects such as gastrointestinal symptoms, weight changes, anticholinergic symptoms, hyponatremia, QT prolongation and possibly serotonin syndrome. Due to the SSRIs role in platelet serotonin depletion, they may be implicated in bleeding events."

Clinical • Cardiovascular • Chronic Kidney Disease • Dyslipidemia • Endocrine Disorders • Heart Failure • Hematological Disorders • Hypertension • Immunology • Infectious Disease • Nephrology • Otorhinolaryngology • Pneumonia • Pulmonary Disease • Renal Disease • Respiratory Diseases • Thrombocytopenia

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