IN CLINICAL PRACTICE

IN CLINICAL PRACTICE

OPTIMIZE CLINICAL TRIAL

An open-label trial evaluating two different ways to initiate XPHOZAH as add-on therapy in patients on phosphate binders with serum phosphorus >5.5 mg/dL1

Trial Design With Two XPHOZAH Initiation Arms1

Chart of OPTIMIZE trial design

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As part of the clinical trial design:
  • Patients were educated on the mechanism and pharmacology of XPHOZAH and counseled to stop stool softeners/laxatives1,2

The data from the OPTIMIZE trial are being provided for informational purposes only. This is not intended to replace your clinical judgment or dosing information in FDA-approved product labeling.

Patient Population
Patients on dialysis with serum phosphorus >5.5 mg/dL on a phosphate binder.1

Trial Limitations
Open-label trial; no placebo control group; endpoints not controlled for type 1 error; results considered descriptive.1

Primary Endpoint Results1

XPHOZAH Initiation Arm 1: Added XPHOZAH, stopped binder

  • 34% of patients achieved serum phosphorus ≤5.5 mg/dL at week 10 compared to 0% at baseline

XPHOZAH Initiation Arm 2: Added XPHOZAH, reduced binder

  • 38% of patients achieved serum phosphorus ≤5.5 mg/dL at week 10 compared to 0% at baseline

Additional Results1

XPHOZAH Initiation Arm 1: Added XPHOZAH, stopped binder

  • Mean serum phosphorus reduction of 0.9 mg/dL at week 10 compared to baseline
  • Median number of daily phosphate lowering pills was reduced from 9 at baseline to 5 at week 10

XPHOZAH Initiation Arm 2: Added XPHOZAH, reduced binder

  • Mean serum phosphorus reduction of 1.0 mg/dL at week 10 compared to baseline
  • Median number of daily phosphate lowering pills was reduced from 9 at baseline to 7 at week 10

BID = twice daily; R = randomized.

Safety1

XPHOZAH Initiation Arm 1: Added XPHOZAH, stopped binder

  • 39% of patients experienced diarrhea and 7% discontinued XPHOZAH due to diarrhea

XPHOZAH Initiation Arm 2: Added XPHOZAH, reduced binder

  • 42% of patients experienced diarrhea and 7% discontinued XPHOZAH due to diarrhea

RELATED LINKS

How to Prescribe

Efficacy

REFERENCES

1.

Data on file. Ardelyx, Inc. 2022.

2.

XPHOZAH® (tenapanor) full Prescribing Information. Waltham, MA: Ardelyx, Inc.; 2023.

Indication

XPHOZAH (tenapanor) 30 mg BID is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.

Important Safety Information

Contraindications

XPHOZAH is contraindicated in:

  • Pediatric patients under 6 years of age
  • Patients with known or suspected mechanical gastrointestinal obstruction

Warnings and precautions

Diarrhea

Patients may experience severe diarrhea. Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea.

Most Common Adverse Reactions

Diarrhea, which occurred in 43-53% of patients, was the only adverse reaction reported in at least 5% of XPHOZAH-treated patients with CKD on dialysis across trials. The majority of diarrhea events in XPHOZAH-treated patients were reported to be mild-to-moderate in severity and resolved over time, or with dose reduction. Diarrhea was typically reported soon after initiation but could occur at any time during treatment with XPHOZAH. Severe diarrhea was reported in 5% of XPHOZAH-treated patients in these trials.

For additional safety information, please see full Prescribing Information.

Indication

XPHOZAH (tenapanor) 30 mg BID is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.

Important Safety Information

Contraindications

XPHOZAH is contraindicated in:

  • Pediatric patients under 6 years of age
  • Patients with known or suspected mechanical gastrointestinal obstruction

Warnings and precautions

Diarrhea

Patients may experience severe diarrhea. Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea.

Most Common Adverse Reactions

Diarrhea, which occurred in 43-53% of patients, was the only adverse reaction reported in at least 5% of XPHOZAH-treated patients with CKD on dialysis across trials. The majority of diarrhea events in XPHOZAH-treated patients were reported to be mild-to-moderate in severity and resolved over time, or with dose reduction. Diarrhea was typically reported soon after initiation but could occur at any time during treatment with XPHOZAH. Severe diarrhea was reported in 5% of XPHOZAH-treated patients in these trials.

For additional safety information, please see full Prescribing Information.

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