Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy

Summary

This is a randomized, double-blind, placebo-controlled study to evaluate the effect of tenapanor on change in s-P levels when tenapanor is administered orally, twice daily for 28 days as adjunctive therapy to ESRD subjects with hyperphosphatemia on stable phosphate binder therapy.

Timeline

Start

2019-02-28

Primary completion

2019-07-17

Completion

2019-07-17

Outcome

Met primary endpoint

registry analysis (superiority test); Tenapanor 30 mg BID vs Placebo; p = 0.0004; Mean Difference (Net) -0.65 (99% CI -1.13 to -0.18); Mixed Models Analysis NCT03824587 ↗

paper patients treated with tenapanor plus binder achieved a larger mean change in serum phosphorus concentration from baseline to week 4 compared with placebo plus binder (-0.84 versus -0.19 mg/dl, P<0.001). PMID 33766811 ↗

release “The AMPLIFY study met the primary endpoint and all key secondary endpoints” ardelyx.com ↗

Publications

• Sprague SM, Weiner DE, Tietjen DP, Pergola PE, Fishbane S, Block GA, Silva AL, Fadem SZ, Lynn RI, Fadda G, Pagliaro L, Zhao S, Edelstein S, Spiegel DM, Rosenbaum DP. Tenapanor as Therapy for Hyperphosphatemia in Maintenance Dialysis Patients: Results from the OPTIMIZE Study. Kidney360. 2024 May 1;5(5):732-742. doi: 10.34067/KID.0000000000000387. Epub 2024 Feb 7.
• Pergola PE, Rosenbaum DP, Yang Y, Chertow GM. A Randomized Trial of Tenapanor and Phosphate Binders as a Dual-Mechanism Treatment for Hyperphosphatemia in Patients on Maintenance Dialysis (AMPLIFY). J Am Soc Nephrol. 2021 Jun 1;32(6):1465-1473. doi: 10.1681/ASN.2020101398. Epub 2021 Mar 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tenapanor	Small molecule	30 mg	Oral
Background	Calcium carbonate	Other / unclassified	—	—
Background	Ferric Citrate	Unknown	—	—
Background	PA21	Unknown	—	—
Background	calcium acetate	Other / unclassified	—	—
Background	sevelamer	Other / unclassified	—	—

Indications