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Dose-finding study of bixalomer in patients with chronic kidney disease on hemodialysis with hyperphosphatemia: a double-blind, randomized, placebo-controlled and sevelamer hydrochloride-controlled open-label, parallel group study.
Ther Apher Dial. 2014 Jun; 18 Suppl 2:24-32.TA

Abstract

Hyperphosphatemia is a prognostic factor for morbidity and mortality in chronic kidney disease. Bixalomer (Kiklin® Capsules) is a non-absorbable polymer that decreases serum phosphate levels by binding phosphate in the gastrointestinal tract. This study was a multicenter, double-blind, randomized, placebo-controlled study to confirm the superiority of bixalomer to placebo for a 4-week treatment period in patients with chronic kidney disease on hemodialysis with hyperphosphatemia. Sevelamer hydrochloride (HCl), a similar non-absorbable polymer, was used as an active comparator for open-label as a reference without statistical comparison for efficacy and safety. The primary endpoint was the change in serum phosphorus level from baseline. The safety profile was also investigated. The number of subjects was 32 in the placebo group and 31 in each bixalomer group (1.5, 3.0 and 4.5 g/day), respectively. The baseline serum phosphorus level was 7.95 to 8.25 mg/dL. Bixalomer showed a significant decrease in serum phosphorus level at all doses compared with placebo, and the adjusted mean change in serum phosphorus level from the baseline to the end of treatment (at Week 4 or at the time of discontinuation) was +0.24 mg/dL in the placebo group, -0.75 mg/dL in the 1.5 g/day group, -1.32 mg/dL in the 3.0 g/day group, and -1.80 mg/dL in the 4.5 g/day group, showing a dose-dependent decrease in serum phosphorus level. The mean change in serum phosphorus level was -2.32 mg/dL in the sevelamer HCl group under the mean dose of 4.8 g/day. Major adverse events included constipation, hard feces, vomiting, etc.; however, none of the adverse events were serious or severe. Consequently, the superiority of bixalomer to placebo and its dose-dependency for treating hyperphosphatemia were confirmed (Clinical trial registration: NCT00505037).

Authors+Show Affiliations

Division of Nephrology, Department of Medicine, Showa University School of Medicine, Toyama, Japan.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24975892

Citation

Akizawa, Tadao, et al. "Dose-finding Study of Bixalomer in Patients With Chronic Kidney Disease On Hemodialysis With Hyperphosphatemia: a Double-blind, Randomized, Placebo-controlled and Sevelamer Hydrochloride-controlled Open-label, Parallel Group Study." Therapeutic Apheresis and Dialysis : Official Peer-reviewed Journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy, vol. 18 Suppl 2, 2014, pp. 24-32.
Akizawa T, Origasa H, Kameoka C, et al. Dose-finding study of bixalomer in patients with chronic kidney disease on hemodialysis with hyperphosphatemia: a double-blind, randomized, placebo-controlled and sevelamer hydrochloride-controlled open-label, parallel group study. Ther Apher Dial. 2014;18 Suppl 2:24-32.
Akizawa, T., Origasa, H., Kameoka, C., Kaneko, Y., & Kanoh, H. (2014). Dose-finding study of bixalomer in patients with chronic kidney disease on hemodialysis with hyperphosphatemia: a double-blind, randomized, placebo-controlled and sevelamer hydrochloride-controlled open-label, parallel group study. Therapeutic Apheresis and Dialysis : Official Peer-reviewed Journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy, 18 Suppl 2, 24-32. https://doi.org/10.1111/1744-9987.12202
Akizawa T, et al. Dose-finding Study of Bixalomer in Patients With Chronic Kidney Disease On Hemodialysis With Hyperphosphatemia: a Double-blind, Randomized, Placebo-controlled and Sevelamer Hydrochloride-controlled Open-label, Parallel Group Study. Ther Apher Dial. 2014;18 Suppl 2:24-32. PubMed PMID: 24975892.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Dose-finding study of bixalomer in patients with chronic kidney disease on hemodialysis with hyperphosphatemia: a double-blind, randomized, placebo-controlled and sevelamer hydrochloride-controlled open-label, parallel group study. AU - Akizawa,Tadao, AU - Origasa,Hideki, AU - Kameoka,Chisato, AU - Kaneko,Yuichiro, AU - Kanoh,Hiroyuki, PY - 2014/7/1/entrez PY - 2014/7/1/pubmed PY - 2015/2/24/medline KW - Bixalomer KW - Dose-finding KW - Hemodialysis KW - Hyperphosphatemia KW - Kidney disease KW - Randomized controlled trial SP - 24 EP - 32 JF - Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy JO - Ther Apher Dial VL - 18 Suppl 2 N2 - Hyperphosphatemia is a prognostic factor for morbidity and mortality in chronic kidney disease. Bixalomer (Kiklin® Capsules) is a non-absorbable polymer that decreases serum phosphate levels by binding phosphate in the gastrointestinal tract. This study was a multicenter, double-blind, randomized, placebo-controlled study to confirm the superiority of bixalomer to placebo for a 4-week treatment period in patients with chronic kidney disease on hemodialysis with hyperphosphatemia. Sevelamer hydrochloride (HCl), a similar non-absorbable polymer, was used as an active comparator for open-label as a reference without statistical comparison for efficacy and safety. The primary endpoint was the change in serum phosphorus level from baseline. The safety profile was also investigated. The number of subjects was 32 in the placebo group and 31 in each bixalomer group (1.5, 3.0 and 4.5 g/day), respectively. The baseline serum phosphorus level was 7.95 to 8.25 mg/dL. Bixalomer showed a significant decrease in serum phosphorus level at all doses compared with placebo, and the adjusted mean change in serum phosphorus level from the baseline to the end of treatment (at Week 4 or at the time of discontinuation) was +0.24 mg/dL in the placebo group, -0.75 mg/dL in the 1.5 g/day group, -1.32 mg/dL in the 3.0 g/day group, and -1.80 mg/dL in the 4.5 g/day group, showing a dose-dependent decrease in serum phosphorus level. The mean change in serum phosphorus level was -2.32 mg/dL in the sevelamer HCl group under the mean dose of 4.8 g/day. Major adverse events included constipation, hard feces, vomiting, etc.; however, none of the adverse events were serious or severe. Consequently, the superiority of bixalomer to placebo and its dose-dependency for treating hyperphosphatemia were confirmed (Clinical trial registration: NCT00505037). SN - 1744-9987 UR - https://www.unboundmedicine.com/medline/citation/24975892/Dose_finding_study_of_bixalomer_in_patients_with_chronic_kidney_disease_on_hemodialysis_with_hyperphosphatemia:_a_double_blind_randomized_placebo_controlled_and_sevelamer_hydrochloride_controlled_open_label_parallel_group_study_ L2 - https://doi.org/10.1111/1744-9987.12202 DB - PRIME DP - Unbound Medicine ER -