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Long-Term Assessment of the Safety and Efficacy of PA21 (Sucroferric Oxyhydroxide) in Japanese Hemodialysis Patients With Hyperphosphatemia: An Open-Label, Multicenter, Phase III Study.
J Ren Nutr. 2017 09; 27(5):346-354.JR

Abstract

OBJECTIVE

The objective of this article was to assess the safety and efficacy of long-term administration of PA21.

DESIGN AND METHODS

Phase III, open-label, long-term study in 15 sites in Japan.

SUBJECTS

Japanese hemodialysis patients (N = 161) with hyperphosphatemia aged ≥20 years undergoing stable maintenance hemodialysis 3 times weekly, for ≥12 weeks.

INTERVENTION

After a 2-week observation period with their previous hyperphosphatemia therapy, patients began the 52-week treatment with PA21, which was administered orally at an initial dose of 250 mg, 3 times daily, immediately before every meal (dosing range between 750 and 3,000 mg/day).

MAIN OUTCOME MEASURE

Safety was evaluated based on the development of adverse events and adverse drug reactions (ADRs). Efficacy was evaluated according to serum phosphorus concentration, corrected serum calcium concentration, and serum intact-parathyroid hormone concentration.

RESULTS

The mean serum phosphorus concentration decreased from 5.46 ± 1.06 mg/dL at baseline to 5.00 ± 1.17 mg/dL at end of treatment. The serum phosphorus concentration was maintained within the target range (3.5-6.0 mg/dL) throughout the 52 weeks of the study period with a mean of 3.3 tablets per day of PA21. Most ADRs were mild, transient, and developed early during treatment, and the incidence was not shown to increase with long-term treatment. The most frequently reported ADR was diarrhea (22.4%).

CONCLUSION

Treatment with PA21 was effective in lowering and maintaining target serum phosphorus concentrations in Japanese hemodialysis patients with hyperphosphatemia over 52 weeks. PA21 was generally well tolerated in the long term.

Authors+Show Affiliations

Division of Nephrology, Department of Medicine, Showa University Fujigaoka Hospital, Yokohama, Japan. Electronic address: koiwa-f@med.showa-u.ac.jp.Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Japan.Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28550969

Citation

Koiwa, Fumihiko, et al. "Long-Term Assessment of the Safety and Efficacy of PA21 (Sucroferric Oxyhydroxide) in Japanese Hemodialysis Patients With Hyperphosphatemia: an Open-Label, Multicenter, Phase III Study." Journal of Renal Nutrition : the Official Journal of the Council On Renal Nutrition of the National Kidney Foundation, vol. 27, no. 5, 2017, pp. 346-354.
Koiwa F, Yokoyama K, Fukagawa M, et al. Long-Term Assessment of the Safety and Efficacy of PA21 (Sucroferric Oxyhydroxide) in Japanese Hemodialysis Patients With Hyperphosphatemia: An Open-Label, Multicenter, Phase III Study. J Ren Nutr. 2017;27(5):346-354.
Koiwa, F., Yokoyama, K., Fukagawa, M., & Akizawa, T. (2017). Long-Term Assessment of the Safety and Efficacy of PA21 (Sucroferric Oxyhydroxide) in Japanese Hemodialysis Patients With Hyperphosphatemia: An Open-Label, Multicenter, Phase III Study. Journal of Renal Nutrition : the Official Journal of the Council On Renal Nutrition of the National Kidney Foundation, 27(5), 346-354. https://doi.org/10.1053/j.jrn.2017.02.007
Koiwa F, et al. Long-Term Assessment of the Safety and Efficacy of PA21 (Sucroferric Oxyhydroxide) in Japanese Hemodialysis Patients With Hyperphosphatemia: an Open-Label, Multicenter, Phase III Study. J Ren Nutr. 2017;27(5):346-354. PubMed PMID: 28550969.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-Term Assessment of the Safety and Efficacy of PA21 (Sucroferric Oxyhydroxide) in Japanese Hemodialysis Patients With Hyperphosphatemia: An Open-Label, Multicenter, Phase III Study. AU - Koiwa,Fumihiko, AU - Yokoyama,Keitaro, AU - Fukagawa,Masafumi, AU - Akizawa,Tadao, Y1 - 2017/05/24/ PY - 2016/11/30/received PY - 2017/02/17/revised PY - 2017/02/25/accepted PY - 2017/5/30/pubmed PY - 2018/5/25/medline PY - 2017/5/29/entrez SP - 346 EP - 354 JF - Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation JO - J Ren Nutr VL - 27 IS - 5 N2 - OBJECTIVE: The objective of this article was to assess the safety and efficacy of long-term administration of PA21. DESIGN AND METHODS: Phase III, open-label, long-term study in 15 sites in Japan. SUBJECTS: Japanese hemodialysis patients (N = 161) with hyperphosphatemia aged ≥20 years undergoing stable maintenance hemodialysis 3 times weekly, for ≥12 weeks. INTERVENTION: After a 2-week observation period with their previous hyperphosphatemia therapy, patients began the 52-week treatment with PA21, which was administered orally at an initial dose of 250 mg, 3 times daily, immediately before every meal (dosing range between 750 and 3,000 mg/day). MAIN OUTCOME MEASURE: Safety was evaluated based on the development of adverse events and adverse drug reactions (ADRs). Efficacy was evaluated according to serum phosphorus concentration, corrected serum calcium concentration, and serum intact-parathyroid hormone concentration. RESULTS: The mean serum phosphorus concentration decreased from 5.46 ± 1.06 mg/dL at baseline to 5.00 ± 1.17 mg/dL at end of treatment. The serum phosphorus concentration was maintained within the target range (3.5-6.0 mg/dL) throughout the 52 weeks of the study period with a mean of 3.3 tablets per day of PA21. Most ADRs were mild, transient, and developed early during treatment, and the incidence was not shown to increase with long-term treatment. The most frequently reported ADR was diarrhea (22.4%). CONCLUSION: Treatment with PA21 was effective in lowering and maintaining target serum phosphorus concentrations in Japanese hemodialysis patients with hyperphosphatemia over 52 weeks. PA21 was generally well tolerated in the long term. SN - 1532-8503 UR - https://www.unboundmedicine.com/medline/citation/28550969/Long_Term_Assessment_of_the_Safety_and_Efficacy_of_PA21__Sucroferric_Oxyhydroxide__in_Japanese_Hemodialysis_Patients_With_Hyperphosphatemia:_An_Open_Label_Multicenter_Phase_III_Study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1051-2276(17)30072-9 DB - PRIME DP - Unbound Medicine ER -