JTT-751 for Treatment of Patients with Hyperphosphatemia on Peritoneal Dialysis

Yokoyama, Keitaro; Akiba, Takashi; Fukagawa, Masafumi; Nakayama, Masaaki; Hirakata, Hideki

doi:10.1159/000366482

Cited by 21 publications

(27 citation statements)

References 19 publications

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“…Yokoyama and colleagues published most recently the results of a phase III, 12-week, multicenter, open-label, dose-adjusted study investigating the efficacy and safety of ferric citrate in 53 Japanese patients with serum phosphorus between 1.8 mmol/L and 3.2 mmol/L undergoing PD [Yokoyama et al 2014a]. The dose of ferric citrate was 1.5-6.0 g/day, targeting serum phosphorus 1.1-1.7 mmol/L.…”

Section: Is There Evidence That Ferric Citrate Is Effective In Treatimentioning

confidence: 99%

Managing hyperphosphatemia in patients with chronic kidney disease on dialysis with ferric citrate: latest evidence and clinical usefulness

Yagil

Fadem

Kant

et al. 2015

Therapeutic Advances in Chronic Disease

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Ferric citrate is a novel phosphate binder that allows the simultaneous treatment of hyperphosphatemia and iron deficiency in patients being treated for end-stage renal disease with hemodialysis (HD). Multiple clinical trials in HD patients have uniformly and consistently demonstrated the efficacy of the drug in controlling hyperphosphatemia with a good safety profile, leading the US Food and Drug Administration in 2014 to approve its use for that indication. A concurrent beneficial effect, while using ferric citrate as a phosphate binder, is its salutary effect in HD patients with iron deficiency being treated with an erythropoietin-stimulating agent (ESA) in restoring iron that becomes available for reversing chronic kidney disease (CKD)-related anemia. Ferric citrate has also been shown in several studies to diminish the need for intravenous iron treatment and to reduce the requirement for ESA. Ferric citrate is thus a preferred phosphate binder that helps resolve CKD-related mineral bone disease and iron-deficiency anemia.

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Section: Is There Evidence That Ferric Citrate Is Effective In Treatimentioning

confidence: 99%

Managing hyperphosphatemia in patients with chronic kidney disease on dialysis with ferric citrate: latest evidence and clinical usefulness

Yagil

Fadem

Kant

et al. 2015

Therapeutic Advances in Chronic Disease

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show abstract

“…These include two studies in nondialysis-dependent CKD patients [40,41], one study exclusively in PD patients [42] and five Phase III studies in patients on maintenance dialysis [43][44][45][46][47].…”

Section: Phase IIImentioning

confidence: 99%

“…Treatment with FCH resulted in significant increases in serum ferritin and TSAT. The most common AE were mild diarrhea and constipation [42].…”

Section: Phase IIImentioning

confidence: 99%

Novel iron-containing phosphate binders for treatment of hyperphosphatemia

Schmid

Lederer²

2015

Expert Opinion on Pharmacotherapy

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On the highly competitive market, where the 'ideal' PB is still unknown, novel substances that offer clear benefits over available drugs are desired. Although SO and FCH showed similar efficacy and safety compared to sevelamer, head-to-head studies with lanthanum carbonate are absent. Clinical 1-year data in a limited patient cohort suggested improved adherence for SO and a large randomized controlled trial showed significant reduction in hospitalizations and costs for FCH. Additional large randomized controlled trials have now to prove these possible advantages. Cost-effectiveness in comparison to other PB and the exclusion of significant harms under long-term treatment will determine the future use of both drugs.

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“…Ferric citrate is a non-calcium, iron-based phosphate binder indicated for the control of serum phosphorus levels in chronic kidney disease (CKD) patients [1][2][3]. It is used to replete iron stores in iron deficiency anemia and reduces the requirement of intravenous iron and erythropoiesis stimulating agents (ESA) [4] and thus, ferric citrate is a dual-purpose therapeutic agent for dialysis patients.…”

Section: Introductionmentioning

confidence: 99%

Long-term iron accumulation in dialysis patients treated with ferric citrate hydrate: a single-center, 80-week retrospective study in Japan

et al. 2017

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Background: Ferric citrate hydrate (FCH), an iron-based phosphate binder, affects mineral and iron metabolism in patients with chronic kidney disease (CKD). The long-term impact of FCH on iron overload is unknown. With this study, we investigated whether the type of dialysis is associated with FCH-related iron accumulation. Methods: This single-center, retrospectively registered, cohort study was performed in Kariya-Toyota General Hospital, Japan, among outpatients undergoing maintenance hemodialysis (HD) or peritoneal dialysis (PD) between July 2014 and January 2017. It included 136 subjects receiving FCH treatment (104 HD patients and 32 PD patients). Their iron metabolism parameters and FCH-associated adverse events were assessed over 80 weeks. Results: In both groups, the weekly darbepoetin alpha dose and erythropoiesis resistance index declined significantly by 16 weeks, although mean hemoglobin concentrations remained stable (10-11 g/dL), and transferrin saturation peaked at 24 weeks. The difference in the weekly darbepoetin alpha dose for HD and PD patients was 16.5 and 12. 0 μg/week, respectively, (P < 0.01). Increases in iron stores were different between the two groups. Peak mean increase in serum ferritin levels (169.0 vs. 63.0 ng/mL, respectively; P = 0.001) in PD patients at 40 weeks was significantly earlier than that in HD patients. The adverse events observed suggest that FCH treatment was more likely to be discontinued within the first 16 weeks due to hemoglobin overshooting in HD patients and after 40 weeks due to ferritin overload in PD patients. Conclusions: Oral iron supplementation with FCH was successful in all dialysis patients. However, the type of dialysis is a major factor associated with iron accumulation during long-term FCH treatment and more likely to occur in PD patients not experiencing regular, dialysis-associated iron loss. Therefore, the method of dialysis should be taken into consideration when evaluating iron stores of patients with CKD to determine the appropriate starting dose of FCH.

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JTT-751 for Treatment of Patients with Hyperphosphatemia on Peritoneal Dialysis

Cited by 21 publications

References 19 publications

Managing hyperphosphatemia in patients with chronic kidney disease on dialysis with ferric citrate: latest evidence and clinical usefulness

Managing hyperphosphatemia in patients with chronic kidney disease on dialysis with ferric citrate: latest evidence and clinical usefulness

Novel iron-containing phosphate binders for treatment of hyperphosphatemia

Long-term iron accumulation in dialysis patients treated with ferric citrate hydrate: a single-center, 80-week retrospective study in Japan

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