Ardelyx Reports Additional Positive Data Supporting Clinical Utility of Tenapanor at ASN's Kidney Week 2021
"These data provide additional perspective on the potential benefits of tenapanor and further support its utility in the management of serum phosphorus," said
"As a person living with kidney disease who has struggled with managing phosphorus, it gives me great hope to see the patient perspective and patient priorities being incorporated into clinical studies," said
New clinical observations presented at ASN:
- ePoster # PO1733 titled "Patient-Reported Experience with Tenapanor in the OPTIMIZE Trial" presents the first data generated from the randomized, open-label OPTIMIZE trial designed to evaluate ways to integrate tenapanor into clinical practice to optimize phosphorus management in patients with CKD on dialysis. Patients who were being treated with phosphate binders were equally divided into two groups: one (n=123) that was switched from binders to tenapanor (straight switch arm), and another (n=123) that reduced their binder dose by 50% upon starting tenapanor 30 mg twice daily (50% binder dose reduction arm). 82.1% of patients in the straight switch arm and 85.4% of patients in the 50% binder dose reduction arm reported an improvement in their overall experience managing phosphorus with tenapanor compared to their previous experience managing phosphorus, primarily due to an improved medication regimen. Approximately 30% of patients reported improved frequency of bowel movements as the top reason for the improved treatment experience with tenapanor.
- ePoster # PO0544 titled "Impact of Tenapanor in Peritoneal Dialysis," based on a post-hoc analysis from the PHREEDOM study, demonstrates similar safety and efficacy in serum phosphorus reduction among patients on peritoneal dialysis (PD) (n=42) and patients on hemodialysis (HD) (n=365) treated with tenapanor. The mean change from baseline to week 26 was -1.70 mg/dL in the PD group vs. -1.33 in the HD group, and the safety profile of tenapanor was also similar between the groups.
- ePoster # TH-OR18 titled "Tenapanor Controls Serum Phosphorus and Reduces PTH and FGF-23 in Patients on Dialysis with Severe Secondary Hyperparathyroidism" evaluates tenapanor's effect on serum phosphorus (sP), parathyroid hormone (PTH) and fibroblast growth factor 23 (FGF23) levels in patients with severe secondary hyperparathyroidism (iPTH>600 pg/mL). In this post-hoc analysis from PHREEDOM, patients treated with tenapanor had ~22%, 34% and 41% reductions in sP, PTH and FGF23, respectively. PTH is a common co-morbidity and elevated levels of FGF23 have been linked to greater risks of LVH (left ventricular hypertrophy) and mortality in patients with CKD.
- ePoster # PO1732 titled "Long-Term Safety of Tenapanor for the Control of Serum Phosphorus in Patients with CKD on Dialysis: Serum Electrolytes and Albumin" evaluates the effects of tenapanor on serum electrolytes and albumin, based on a post-hoc analysis from the three tenapanor pivotal trials, all of which met their primary and key secondary endpoints, and shows that tenapanor decreases serum phosphorus selectively by inhibiting paracellular absorption of phosphate without affecting other serum electrolytes (sodium, bicarbonate, chloride, potassium, calcium, magnesium) or serum albumin.
OPTIMIZE is a randomized, open label study, which included 330 patients with chronic kidney disease (CKD) on dialysis with hyperphosphatemia. The study was designed to evaluate different methods of initiating tenapanor to optimize phosphorus management in both binder-naïve and binder-treated patients. The objective was to evaluate the ability of tenapanor, with its novel blocking mechanism, administered as core therapy for the treatment of hyperphosphatemia in adult patients with chronic kidney disease (CKD) on dialysis, alone or in combination with phosphate binders, to achieve target serum phosphorus (s-P) levels ≤5.5 mg/dL. Patients with s-P >5.5 and ≤10.0 mg/dL during stable phosphate binder treatment were randomized in a 1:1 ratio to two different treatment cohorts: Cohort 1, a straight switch approach where current phosphate binder treatment was discontinued and patients were switched to tenapanor 30 mg twice daily (BID) or Cohort 2, where current phosphate binder dose was reduced by at least 50% and tenapanor therapy was initiated at 30 mg BID. After week 2, investigators could adjust phosphate binder dose to achieve a phosphorus level of ≤5.5 mg/dL with tenapanor as the core therapy and binders as adjunctive. A third cohort comprised of phosphate binder naïve patients with s-P >4.5 and ≤10.0 mg/dL (Cohort 3) were enrolled and initiated on tenapanor 30 mg BID.
Tenapanor, discovered and developed by
Hyperphosphatemia is a serious condition resulting in an abnormally elevated level of phosphorus in the blood that is estimated to affect the vast majority of the 550,000 patients in
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