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Dose-response efficacy and safety of PA21 in Japanese hemodialysis patients with hyperphosphatemia: a randomized, placebo-controlled, double-blind, Phase II study.
Clin Exp Nephrol. 2017 Jun; 21(3):513-522.CE

Abstract

BACKGROUND

Hyperphosphatemia is common in chronic kidney disease (CKD) and associated with mortality and morbidity. We aimed to evaluate the dose-dependent efficacy and safety of PA21 (sucroferric oxyhydroxide), an iron-based phosphate binder, in Japanese hemodialysis patients with hyperphosphatemia.

METHODS

In this double-blind, multicenter, Phase II study, 183 patients were randomized to placebo or PA21 at doses of 250, 500, 750, or 1000 mg (based on iron content) three times/day for 6 weeks. The primary efficacy endpoint was the mean change in serum phosphorus levels from baseline to end of treatment in each group. Adverse reactions were evaluated.

RESULTS

The change in serum phosphorus level was significantly greater in each PA21 group than in the placebo group (analysis of covariance: P < 0.001 for all groups). A dose-dependent change in serum phosphorus levels was observed in the PA21 groups. A notable decrease in mean serum phosphorus levels to the target level of ≤6 mg/dL was shown starting at Week 1 in all PA21 groups. The cumulative achievement rates for target serum phosphorus level at the end of treatment were generally >80 % in all PA21 groups. The major adverse reaction reported was diarrhea; however, most cases were mild.

CONCLUSIONS

PA21 was an effective and safe treatment that decreased serum phosphorus levels starting at 1 week of treatment when administered as one 250-mg tablet three times/day. PA21 demonstrated a dose-dependent phosphorus lowering effect up to 3000 mg/day. PA21 may be a new treatment alternative with relatively low pill burden for Japanese hemodialysis patients with hyperphosphatemia.

Authors+Show Affiliations

Division of Nephrology, Department of Medicine, Showa University Fujigaoka Hospital, 1-30 Fujigaoka, Aoba-ku, Yokohama, 227-8501, Japan. koiwa-f@med.showa-u.ac.jp.Biostatistics, Faculty of Pharmaceutical Sciences, Josai University, Sakado, Japan.

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

27389681

Citation

Koiwa, Fumihiko, and Akira Terao. "Dose-response Efficacy and Safety of PA21 in Japanese Hemodialysis Patients With Hyperphosphatemia: a Randomized, Placebo-controlled, Double-blind, Phase II Study." Clinical and Experimental Nephrology, vol. 21, no. 3, 2017, pp. 513-522.
Koiwa F, Terao A. Dose-response efficacy and safety of PA21 in Japanese hemodialysis patients with hyperphosphatemia: a randomized, placebo-controlled, double-blind, Phase II study. Clin Exp Nephrol. 2017;21(3):513-522.
Koiwa, F., & Terao, A. (2017). Dose-response efficacy and safety of PA21 in Japanese hemodialysis patients with hyperphosphatemia: a randomized, placebo-controlled, double-blind, Phase II study. Clinical and Experimental Nephrology, 21(3), 513-522. https://doi.org/10.1007/s10157-016-1299-z
Koiwa F, Terao A. Dose-response Efficacy and Safety of PA21 in Japanese Hemodialysis Patients With Hyperphosphatemia: a Randomized, Placebo-controlled, Double-blind, Phase II Study. Clin Exp Nephrol. 2017;21(3):513-522. PubMed PMID: 27389681.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Dose-response efficacy and safety of PA21 in Japanese hemodialysis patients with hyperphosphatemia: a randomized, placebo-controlled, double-blind, Phase II study. AU - Koiwa,Fumihiko, AU - Terao,Akira, Y1 - 2016/07/07/ PY - 2016/02/01/received PY - 2016/06/13/accepted PY - 2016/7/9/pubmed PY - 2018/4/3/medline PY - 2016/7/9/entrez KW - Hemodialysis KW - Hyperphosphatemia KW - Japanese KW - PA21 compound KW - Phosphate binder KW - Sucroferric oxyhydroxide SP - 513 EP - 522 JF - Clinical and experimental nephrology JO - Clin Exp Nephrol VL - 21 IS - 3 N2 - BACKGROUND: Hyperphosphatemia is common in chronic kidney disease (CKD) and associated with mortality and morbidity. We aimed to evaluate the dose-dependent efficacy and safety of PA21 (sucroferric oxyhydroxide), an iron-based phosphate binder, in Japanese hemodialysis patients with hyperphosphatemia. METHODS: In this double-blind, multicenter, Phase II study, 183 patients were randomized to placebo or PA21 at doses of 250, 500, 750, or 1000 mg (based on iron content) three times/day for 6 weeks. The primary efficacy endpoint was the mean change in serum phosphorus levels from baseline to end of treatment in each group. Adverse reactions were evaluated. RESULTS: The change in serum phosphorus level was significantly greater in each PA21 group than in the placebo group (analysis of covariance: P < 0.001 for all groups). A dose-dependent change in serum phosphorus levels was observed in the PA21 groups. A notable decrease in mean serum phosphorus levels to the target level of ≤6 mg/dL was shown starting at Week 1 in all PA21 groups. The cumulative achievement rates for target serum phosphorus level at the end of treatment were generally >80 % in all PA21 groups. The major adverse reaction reported was diarrhea; however, most cases were mild. CONCLUSIONS: PA21 was an effective and safe treatment that decreased serum phosphorus levels starting at 1 week of treatment when administered as one 250-mg tablet three times/day. PA21 demonstrated a dose-dependent phosphorus lowering effect up to 3000 mg/day. PA21 may be a new treatment alternative with relatively low pill burden for Japanese hemodialysis patients with hyperphosphatemia. SN - 1437-7799 UR - https://www.unboundmedicine.com/medline/citation/27389681/Dose_response_efficacy_and_safety_of_PA21_in_Japanese_hemodialysis_patients_with_hyperphosphatemia:_a_randomized_placebo_controlled_double_blind_Phase_II_study_ L2 - https://dx.doi.org/10.1007/s10157-016-1299-z DB - PRIME DP - Unbound Medicine ER -