Efficacy and safety of SBR759, a new iron-based phosphate binder

Block, Geoffrey A.; Brillhart, Stephanie; Persky, Martha S.; Amer, Ahmed; Slade, Alan

doi:10.1038/ki.2010.23

Cited by 33 publications

(29 citation statements)

References 20 publications

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“…Several studies have shown that ferric compounds, including SBR759 and PA21, have serum phosphorus-reducing effects in hemodialysis and predialysis CKD patients; however, a relatively high dose of these compounds may be required to obtain efficacy [13,14,15,16,17,18]. Ferric citrate hydrate (JTT-751) is a novel calcium-free phosphate binder, currently being developed as a treatment for hyperphosphatemia in CKD patients.…”

Section: Introductionmentioning

confidence: 99%

Ferric Citrate Hydrate, a New Phosphate Binder, Prevents the Complications of Secondary Hyperparathyroidism and Vascular Calcification

et al. 2013

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Background/Aims: Ferric citrate hydrate (JTT-751) is being developed as a treatment for hyperphosphatemia in chronic kidney disease patients, and shows serum phosphorus-reducing effects on hyperphosphatemia in hemodialysis patients. We examined whether JTT-751 could reduce phosphorus absorption in normal rats and prevent the progression of ectopic calcification, secondary hyperparathyroidism and bone abnormalities in chronic renal failure (CRF) rats. Methods: Normal rats were fed a diet containing 0.3, 1 or 3% JTT-751 for 7 days. The effects of JTT-751 on phosphorus absorption were evaluated with fecal and urinary phosphorus excretion. Next, a CRF model simulating hyperphosphatemia was induced by feeding rats a 0.75% adenine diet. After 21 days of starting the adenine diet feeding, 1 or 3% JTT-751 was administered for 35 days by dietary admixture. The serum phosphorus levels and mineral parameters were measured. Calcification in the aorta was examined biochemically and histopathologically. Hyperparathyroidism and bone abnormalities were evaluated by histopathological analysis of the parathyroid and femur, respectively. Results: In normal rats, JTT-751 increased fecal phosphorus excretion and reduced phosphorus absorption and urinary phosphorus excretion. In CRF rats, JTT-751 reduced serum phosphorus levels, the calcium-phosphorus product and calcium content in the aorta. Serum intact parathyroid hormone levels and the incidence and severity of parathyroid hyperplasia were also decreased. JTT-751 reduced femoral bone fibrosis, porosity and osteoid formation. Conclusions: JTT-751 could bind with phosphate in the gastrointestinal tract, increase fecal phosphorus excretion and reduce phosphorus absorption. JTT-751 could prevent the progression of ectopic calcification, secondary hyperparathyroidism and bone abnormalities in rats.

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Section: Introductionmentioning

confidence: 99%

Ferric Citrate Hydrate, a New Phosphate Binder, Prevents the Complications of Secondary Hyperparathyroidism and Vascular Calcification

et al. 2013

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“…10,11 JTT-751 has a larger surface area and faster dissolution rate than ferric citrate, and is expected to demonstrate efficacy as a phosphate binder. 12 SBR759, an iron (III) oxide-hydroxide (FeO(OH))-starch-sucrose-carbonate complex, 13 binds to phosphates in food via ligand exchange mechanism in the gastrointestinal tract. Sucroferric oxyhydroxide (PA21) is a new calcium-free polynuclear iron(III)-oxyhydroxide phosphate binder with a high phosphate binding capacity over a wide pH range.…”

Section: Introductionmentioning

confidence: 99%

Effects and safety of iron-based phosphate binders in dialysis patients: a systematic review and meta-analysis

Zhai

Yang

et al. 2014

Renal Failure

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Aim: To assess the effects and safety of iron-based phosphate binders in adult patients receiving dialysis. Methods: We electronically searched MEDLINE, EMBASE, CENTRAL, and CBM for randomized controlled trials about iron-based phosphate binders in adult dialysis patients. Study quality was assessed using the criteria outlined in the Cochrane Handbook for Systematic Reviews of intervention. Meta-analysis was conducted by RevMan 5.3. Results: Eight studies with 2018 participants were eligible for our meta-analysis. Iron-based phosphate binders were superior to placebo (MD ¼ À2.43 mg/dL, 95% CI: À3.18 to À1.68, p50.00001) and as efficient as sevelamer (MD ¼ 0.04 mg/dL, 95% CI: À0.29 to 0.36, p ¼ 0.83) in reducing serum phosphorus in dialysis patients. No significant differences were found in all adverse events (OR ¼ 1.30, 95% CI: 0.77 to 2.20, p ¼ 0.32) between iron-based phosphate binders and placebo. Iron-based phosphate binders were associated with significant higher serum iron (MD ¼ 9.39 ng/mL, 95% CI 1.48 to 17.30, p ¼ 0.02), higher serum transferring saturation (MD ¼ 6.29%, 95% CI 2.72 to 9.87, p ¼ 0.0006) and lower serum total iron binding capacity (MD ¼ À23.13 mg/dL, 95% CI À35.69 to À10.58, p ¼ 0.0003) in comparison to placebo. Conclusion: Iron-based phosphate binders are as effective as sevelamer and well tolerated for hyperphosphatemia in dialysis patients. Iron-based phosphate binders appear to have a beneficial effect on renal anemia in patients receiving dialysis. Therefore, iron-based phosphate binders may represent a new treatment option for dialysis patients.

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“…SBR759, a polymeric complex composed of iron (III) oxide and starch, and PA21, a stabilized polynuclear iron (III) oxyhydroxide, have serum P-reducing effects in hemodialysis and predialysis CKD patients; however, a relatively high dose of these compounds may be required to obtain efficacy [18,19,20]. …”

Section: Introductionmentioning

confidence: 99%

Effect of Oral JTT-751 (Ferric Citrate) on Hyperphosphatemia in Hemodialysis Patients: Results of a Randomized, Double-Blind, Placebo-Controlled Trial

et al. 2012

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Background/Aims: JTT-751 (ferric citrate hydrate) is a novel oral, iron-based phosphate binder being developed for the treatment of hyperphosphatemia among chronic kidney disease patients who are on dialysis. This study investigated the dose-response and safety of JTT-751 among Japanese hemodialysis patients. Methods: This was a multicenter, randomized, placebo-controlled, double-blind, parallel-group, comparative study. A total of 192 subjects with serum phosphorus (P) levels between 6.1 and 10.0 mg/dl were randomized to JTT-751 (1.5, 3 or 6 g/day) or to placebo treatment for 28 days. Changes in serum P level from baseline were examined. Results: In the full analysis set, the mean change in serum P level at week 4 was 0.04, –1.28, –2.16 and –4.10 mg/dl in the placebo, 1.5-grams, 3-grams and 6-grams/day groups, respectively, demonstrating a dose-response relationship up to 6 g/day. Overall, a reduction in serum P levels to ≤5.5 mg/dl was achieved in 2.5, 16.7, 50.0 and 92.6% of subjects, in the placebo, 1.5-grams, 3-grams and 6-grams/day groups, respectively. The most common adverse events (AEs) were gastrointestinal disorders. Most AEs were mild. In 25 patients, treatment was discontinued due to increased transferrin saturation ≥50%; however, this was not considered to be a safety issue. Conclusions: When hemodialysis subjects received JTT-751 at doses between 1.5 and 6 g/day for 28 days, serum P levels were significantly reduced in a dose-dependent manner (p < 0.001). JTT-751 was found to be efficacious and safe, with the majority of subjects in the 6-grams/day group achieving a serum P level of ≤5.5 mg/dl.

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Efficacy and safety of SBR759, a new iron-based phosphate binder

Cited by 33 publications

References 20 publications

Ferric Citrate Hydrate, a New Phosphate Binder, Prevents the Complications of Secondary Hyperparathyroidism and Vascular Calcification

Ferric Citrate Hydrate, a New Phosphate Binder, Prevents the Complications of Secondary Hyperparathyroidism and Vascular Calcification

Effects and safety of iron-based phosphate binders in dialysis patients: a systematic review and meta-analysis

Effect of Oral JTT-751 (Ferric Citrate) on Hyperphosphatemia in Hemodialysis Patients: Results of a Randomized, Double-Blind, Placebo-Controlled Trial

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