Randomized Open-Label Study to Evaluate Tenapanor as the Core Therapy in the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Who Are Phosphate Binder Naive or on Phosphate Binders to Optimize Phosphorus Management

TEN-02-402

This is a randomized, open-label study to evaluate different methods of initiating tenapanor therapy in CKD patients on dialysis with hyperphosphatemia, when they are either phosphate binder naïve or on phosphate binder therapy. The objective to evaluate the effect of tenapanor alone or in combination with phosphate binders to achieve target serum phosphorus (s-P) levels of ≤5.5 mg/dL when tenapanor is administered as the core therapy (alone or in combination with phosphate binders) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.

2020-11-20

2021-10-13

2021-12-01

Completed

Early phase I

333

Inclusion Criteria: 1. Signed and dated informed consent form prior to any study specific procedures. 2. Males or females aged 18 to 80 years, inclusive, at Screening (Visit 1). 3. Females must be non-pregnant and non-lactating. 4. Patients on phosphate binder therapy must be on chronic maintenance hemodialysis (HD) 3 times per week for at least 3 months or chronic maintenance peritoneal dialysis (PD) for a minimum of 6 months. If modality of dialysis has changed, the patient must meet one of the two dialysis criteria above and been on the new modality of dialysis for a minimum of one month. Phosphate binder naïve patients must be on chronic maintenance HD 3 times per week or chronic maintenance PD. 5. Kt/V ≥1.2 at most recent measurement prior to Screening (Visit 1). 6. Prescribed and taking phosphate binder medication at least 3 times per day or being phosphate binder naïve; defined as having not taken phosphate binders for at least 3 months prior to Screening. The patient must be taking a minimum of 6 pills per day for Renvela, Auryxia, or PhosLo; and/or a minimum of 3 pills per day for Fosrenol or Velphoro. 7. For patients taking phosphate binders, both the s-P level at the most recent measurement prior to Screening (Visit 1) and the s-P level at Screening (Visit 1) must be \>5.5 and ≤10.0 mg/dL. 8. For phosphate binder naïve patients, the s-P level at Screening (Visit 1) must be \>4.5 and ≤10.0 mg/dL. 9. Able to understand and comply with the protocol. Exclusion Criteria: 1. Severe hyperphosphatemia defined as having an s-P level \>10.0 mg/dL at any time point during routine clinical monitoring for the 3 preceding months before Screening (Visit 1). 2. Serum/plasma PTH \>1200 pg/mL. The most recent value from the patient's medical records should be used. 3. Clinical signs of hypovolemia at Screening (Visit 1) as judged by the Investigator. 4. History of inflammatory bowel disease or irritable bowel syndrome with diarrhea. 5. Scheduled for living donor kidney transplant or plans to relocate to another center during the study. 6. Use of an investigational agent within 30 days prior to Screening (Visit 1). 7. Involvement in the planning and/or conduct of the study (applies to both Ardelyx/Contract Research Organization (CRO) staff and/or staff at the study site). 8. If, in the opinion of the Investigator, the patient is unable or unwilling to fulfill the requirements of the protocol or has a condition which would render the results uninterpretable.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 333, 'type': 'ACTUAL'}}

2023-03-29