Effect of Tenapanor on Phosphate Binder Pill Burden in Hemodialysis Patients

Akizawa, Tadao; Sato, Yu; Ikejiri, Kazuaki; Kanda, Hironori; Fukagawa, Masafumi

doi:10.1016/j.ekir.2021.06.030

Cited by 11 publications

(7 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…A recent study demonstrated that adding tenapanor to the phosphate binder regimen of hemodialysis patients decreased the number of daily phosphate binder tablets necessary to achieve a serum phosphorus level within the baseline range of ±0.5 mg/dL. 22 The serum phosphorus level-lowering effect and safety of tenapanor in Japanese patients with hyperphosphatemia undergoing hemodialysis have not been evaluated. This The study had a screening period (from the date of providing informed consent until preenrollment), a first washout period (up to 3 weeks from pre-enrollment until enrollment), a treatment period (6-week treatment period [Weeks 0 to 6]), and a second washout period (3 weeks after completion of the study treatment [Weeks 7 to 9]) (Figure 1).…”

Section: Introductionmentioning

confidence: 99%

Dose-Response of Tenapanor in Patients With Hyperphosphatemia Undergoing Hemodialysis in Japan—A Phase 2 Randomized Trial

Inaba¹,

Une

Ikejiri

et al. 2022

Kidney International Reports

Self Cite

View full text Add to dashboard Cite

Section: Introductionmentioning

confidence: 99%

Dose-Response of Tenapanor in Patients With Hyperphosphatemia Undergoing Hemodialysis in Japan—A Phase 2 Randomized Trial

Inaba¹,

Une

Ikejiri

et al. 2022

Kidney International Reports

Self Cite

View full text Add to dashboard Cite

“…As a reference, a minimum of 100 patients was required for a 52-week study evaluating the long-term safety of tenapanor. Based on previous phase 2 and 3 studies 11 , 12 , we assumed a withdrawal rate of 50%. Thus, the target sample size was set as 200 patients.…”

Section: Methodsmentioning

confidence: 99%

Long-term safety and decrease of pill burden by tenapanor therapy: a phase 3 open-label study in hemodialysis patients with hyperphosphatemia

Koiwa,

Sato,

Ohara

et al. 2023

Sci Rep

Self Cite

View full text Add to dashboard Cite

Phosphate binders (PBs) generally have a high pill burden. Tenapanor selectively inhibits sodium/hydrogen exchanger isoform 3, reducing intestinal phosphate absorption. Tenapanor is a novel drug administered as a small tablet, twice daily. This multicenter, open-label, single-arm, phase 3 study aimed to evaluate the long-term safety of tenapanor and its efficacy in decreasing PB pill burden. Tenapanor 5 mg twice daily was administered to hemodialysis patients with serum phosphorus level 3.5–7.0 mg/dl at baseline; the dose could be increased up to 30 mg twice daily. Patients could also switch from PBs. The primary endpoint was safety during 52-week administration. The key secondary endpoint was a ≥ 30% reduction in the total pill number of daily PBs and tenapanor from baseline. Of 212 patients starting treatment, 154 completed the study. Diarrhea was the most frequent adverse event, occurring in 135 patients (63.7%); most events were classified as mild (74.8%). No clinically significant changes occurred other than serum phosphorus level. At Week 52/discontinuation, 158/204 patients (77.5%) achieved the key secondary endpoint. Complete switching from PBs to tenapanor was achieved in 50–76 patients (26.7%–41.5%), and 80 patients (51.9%) at Week 8–12 and Week 50, respectively. Serum phosphorus remained generally stable within the target range (3.5–6.0 mg/dl). These findings suggest the long-term safety and tolerability of tenapanor. Tenapanor could reduce or eliminate PB pill burden while controlling serum phosphorus levels.Trial registration: NCT04771780

show abstract

“… 80 It is administered as 1 tablet taken twice a day, which may significantly decrease the pill burden for patients with hyperphosphatemia who currently need to take approximately 9 phosphate binder pills each day. 59 , 82 A recent trial revealed that 72% of patients achieved the primary end point of ≥30% decrease in the number of daily binder and tenapanor tablets compared with the number of daily binder tablets at baseline ( P < 0.001). The mean total number of phosphate-lowering tablets per day decreased from 15 at baseline to 3 at week 26, with a mean decrease of 12.1 binder tablets per day, and 30% of patients completely switched from binders to tenapanor ( P < 0.001).…”

Section: Evolution Of Phosphate Management Therapiesmentioning

confidence: 99%

Past, Present, and Future of Phosphate Management

Doshi

Wish

2022

Kidney International Reports

View full text Add to dashboard Cite

This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

show abstract

Effect of Tenapanor on Phosphate Binder Pill Burden in Hemodialysis Patients

Cited by 11 publications

References 12 publications

Dose-Response of Tenapanor in Patients With Hyperphosphatemia Undergoing Hemodialysis in Japan—A Phase 2 Randomized Trial

Dose-Response of Tenapanor in Patients With Hyperphosphatemia Undergoing Hemodialysis in Japan—A Phase 2 Randomized Trial

Long-term safety and decrease of pill burden by tenapanor therapy: a phase 3 open-label study in hemodialysis patients with hyperphosphatemia

Past, Present, and Future of Phosphate Management

Contact Info

Product

Resources

About