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Kidney Week

Abstract: TH-PO160

Efficacy and Safety of Tenapanor on Hyperphosphatemia in Japanese Hemodialysis Patients: Results of a Randomized Phase 3 Trial

Session Information

  • CKD-MBD: Targets and Outcomes
    November 03, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category: Bone and Mineral Metabolism

  • 402 Bone and Mineral Metabolism: Clinical

Authors

  • Fukagawa, Masafumi, Tokai University School of Medicine, Isehara, Japan
  • Ikejiri, Kazuaki, Kyowa Kirin Co., Ltd., Tokyo, Japan
  • Kinoshita, Jun, Kyowa Kirin Co., Ltd., Tokyo, Japan
  • Nakanishi, Kaoru, Kyowa Kirin Co., Ltd., Tokyo, Japan
  • Akizawa, Tadao, Showa University School of Medicine, Tokyo, Japan
Background

Phosphate binders (PB) are commonly used for hyperphosphatemia in hemodialysis (HD) patients, although some patients do not have sufficient phosphorus control. Poor adherence to PB due to adverse events and heavy pill burden often plays significant roles in such patients. Tenapanor (TEN) is a novel potent treatment for hyperphosphatemia that reduces serum phosphorus (sP) level through selective inhibition of sodium/hydrogen exchanger 3 antiporter and the reduction in paracellular phosphorus absorption. The purpose of this trial was to confirm the efficacy and safety of TEN on hyperphosphatemia in Japanese HD patients.

Methods

This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 trial in Japanese HD patients. The trial comprised three periods (screening, up to 3-week washout, 8-week treatment). Patients in screening were enrolled when the sP level at the first dialysis session of the week was 3.5−6.0 mg/dL (the target range by Japanese Society for Dialysis Therapy) and increased by ≥1.0 mg/dL to 6.1−9.9 mg/dL after washout of PB. Enrolled patients were randomized 1:1 to the placebo or TEN groups. TEN 5 mg was administered twice/day as the starting dose and titrated in a stepwise manner within the range of 5, 10, 20 and 30 mg twice/day based on the sP level. The primary endpoint was the mean change in sP level at week 8 from baseline.

Results

One-hundred and sixty-four subjects were enrolled (82 subjects per group). The week 8 sP (primary endpoint) decreased 1.89 mg/dL in the TEN group and increased 0.05 mg/dL in the placebo group (difference −1.95 mg/dL [95%CI −2.37 mg/dL, −1.53 mg/dL], p<0.0001). In the TEN group, the percentage of subjects achieving the target sP (3.5−6.0 mg/dL) gradually increased to 69.2% as the mean dose of TEN was up-titrated to 18.1 mg at the end. In each group, the major adverse event was diarrhea (TEN group: 74.4%, placebo group: 19.5%). In most of the patients, diarrhea was mild in severity and only two subjects withdrew for diarrhea in the TEN group.

Conclusion

TEN significantly decreased sP compared with placebo and was well tolerated in Japanese HD patients. These results suggest that TEN can be a new option for the hyperphosphatemia treatment.

Funding

  • Commercial Support