We are analyzing https://link.springer.com/article/10.1007/s10157-022-02204-1.

Title:
Safety and effectiveness of ferric citrate hydrate in serum phosphorus management of patients with chronic kidney disease: a long-term, real-world, observational, post-marketing surveillance study | Clinical and Experimental Nephrology
Description:
Background Ferric citrate hydrate (FC) is an oral iron-based phosphate binder that is used to treat hyperphosphatemia in patients with chronic kidney disease (CKD). This post-marketing surveillance study was performed to investigate the long-term safety and effectiveness of FC. Methods This prospective, multicenter, observational post-marketing surveillance study was performed in a real-world setting in Japan. The study involved CKD patients with hyperphosphatemia receiving FC who were undergoing either hemodialysis or peritoneal dialysis or were non-dialysis-dependent. Adverse drug reactions, iron- and erythrocyte-related parameters (i.e., levels of serum ferritin, transferrin saturation, and hemoglobin), and serum levels of phosphorus, corrected calcium, and intact parathyroid hormone were monitored for up to 104 weeks. Results Safety was evaluated in 2723 patients. Of these patients, 20.5% discontinued FC because of adverse events, and 3.9% discontinued FC because of unsatisfactory effectiveness. Iron-related parameters gradually increased after the initiation of FC treatment but stabilized after week 36. Effectiveness was analyzed in 2367 patients. Serum phosphorus immediately decreased, and the effect persisted for 104 weeks. Conclusion In this 104 week surveillance study, no new safety concerns were noted. The safety profile was not obviously different from those in pre-approval clinical trials and the 52 week interim report of this surveillance study. The serum ferritin level of most patients was below the upper limit of the target range, and iron overload risk was not evident. Long-term FC treatment effectively controlled serum phosphorus.
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Keywords {🔍}

patients, serum, treatment, safety, study, groups, ckd, group, surveillance, iron, article, analysis, levels, ferric, japan, dialysis, ferritin, effectiveness, citrate, kidney, disease, set, table, clinical, hyperphosphatemia, nondialysisdependent, initiation, week, level, google, scholar, phosphate, hemodialysis, hydrate, longterm, adrs, data, peritoneal, increase, fig, ngml, chronic, undergoing, parameters, events, mgdl, postmarketing, yokoyama, hemoglobin, anemia,

Topics {✒️}

post-marketing surveillance study pre-approval clinical trials phosphorus absorption-reducing effect dialysis-dependent long-term safety pre-approval clinical studies jikei university school article download pdf post-marketing surveillance iron-based phosphate binder impaired bone metabolism open access license iron-based phosphate binders real-world clinical setting disorders lead medical writing support treat iron-deficiency anemia fc effectively controlled continuous monitoring hiroyuki susai privacy choices/manage cookies managed serum phosphorus high plasma phosphate adverse drug reactions general clinical practice experimental nephrology aims improving global outcomes surveillance study include long-term safety ferric citrate hydrate chronic kidney disease received hyperphosphatemia therapy clinical decision-making randomised clinical trial long-term treatment noriaki nishino preferred terms defined gastric secretion inhibitors full access full size table serum phosphorus management elemental ferric iron attenuate renoprotective effect sodium ferrous citrate iron-related parameters erythrocyte-related parameters diabetic kidney disease iron-deficiency anemia iron deficiency anemia methods surveillance design article yokoyama

Schema {🗺️}

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         headline:Safety and effectiveness of ferric citrate hydrate in serum phosphorus management of patients with chronic kidney disease: a long-term, real-world, observational, post-marketing surveillance study
         description:Ferric citrate hydrate (FC) is an oral iron-based phosphate binder that is used to treat hyperphosphatemia in patients with chronic kidney disease (CKD). This post-marketing surveillance study was performed to investigate the long-term safety and effectiveness of FC. This prospective, multicenter, observational post-marketing surveillance study was performed in a real-world setting in Japan. The study involved CKD patients with hyperphosphatemia receiving FC who were undergoing either hemodialysis or peritoneal dialysis or were non-dialysis-dependent. Adverse drug reactions, iron- and erythrocyte-related parameters (i.e., levels of serum ferritin, transferrin saturation, and hemoglobin), and serum levels of phosphorus, corrected calcium, and intact parathyroid hormone were monitored for up to 104 weeks. Safety was evaluated in 2723 patients. Of these patients, 20.5% discontinued FC because of adverse events, and 3.9% discontinued FC because of unsatisfactory effectiveness. Iron-related parameters gradually increased after the initiation of FC treatment but stabilized after week 36. Effectiveness was analyzed in 2367 patients. Serum phosphorus immediately decreased, and the effect persisted for 104 weeks. In this 104 week surveillance study, no new safety concerns were noted. The safety profile was not obviously different from those in pre-approval clinical trials and the 52 week interim report of this surveillance study. The serum ferritin level of most patients was below the upper limit of the target range, and iron overload risk was not evident. Long-term FC treatment effectively controlled serum phosphorus.
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            Chronic kidney disease
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      headline:Safety and effectiveness of ferric citrate hydrate in serum phosphorus management of patients with chronic kidney disease: a long-term, real-world, observational, post-marketing surveillance study
      description:Ferric citrate hydrate (FC) is an oral iron-based phosphate binder that is used to treat hyperphosphatemia in patients with chronic kidney disease (CKD). This post-marketing surveillance study was performed to investigate the long-term safety and effectiveness of FC. This prospective, multicenter, observational post-marketing surveillance study was performed in a real-world setting in Japan. The study involved CKD patients with hyperphosphatemia receiving FC who were undergoing either hemodialysis or peritoneal dialysis or were non-dialysis-dependent. Adverse drug reactions, iron- and erythrocyte-related parameters (i.e., levels of serum ferritin, transferrin saturation, and hemoglobin), and serum levels of phosphorus, corrected calcium, and intact parathyroid hormone were monitored for up to 104 weeks. Safety was evaluated in 2723 patients. Of these patients, 20.5% discontinued FC because of adverse events, and 3.9% discontinued FC because of unsatisfactory effectiveness. Iron-related parameters gradually increased after the initiation of FC treatment but stabilized after week 36. Effectiveness was analyzed in 2367 patients. Serum phosphorus immediately decreased, and the effect persisted for 104 weeks. In this 104 week surveillance study, no new safety concerns were noted. The safety profile was not obviously different from those in pre-approval clinical trials and the 52 week interim report of this surveillance study. The serum ferritin level of most patients was below the upper limit of the target range, and iron overload risk was not evident. Long-term FC treatment effectively controlled serum phosphorus.
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         Non-dialysis-dependent
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      name:Pharmaceutical Division, Japan Tobacco Inc., Tokyo, Japan
      name:Pharmaceutical Division, Japan Tobacco Inc., Tokyo, Japan
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      name:Pharmaceutical Division, Japan Tobacco Inc., Tokyo, Japan
      name:Pharmaceutical Division, Japan Tobacco Inc., Tokyo, Japan
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