Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia

NCT04549597 | Completed Phase 4 Results FDA Drug

• 1 other identifier: TEN-02-402
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis; Hyperphosphatemia

Keywords

hyperphosphatemia

Outcome Measures

Primary Outcomes (1)

• Effect of Tenapanor to Achieve Target s-P Levels of Less Than or Equal to 5.5 mg/dL

  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 for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.

  10 weeks

Secondary Outcomes (2)

• To Evaluate the Effect of Tenapanor to Achieve Various s-P Levels ≤4.5 mg/dL

  10 weeks

• To Evaluate the Effect of Tenapanor on Reducing Daily Phosphorus-lowering Therapy Pill Burden.

  10 weeks

Study Arms (3)

Cohort 1: Straight Switch

EXPERIMENTAL

Patients stop taking phosphate binders and start tenapanor 30 mg twice daily

Drug: Tenapanor

Cohort 2: Decrease Phosphate Binder by 50%

EXPERIMENTAL

Decreases phosphate binder dose by at least 50% with the ability to switch the binder regiment from thrice daily (TID) to BID or once a day and initiates tenapanor 30 mg BID

Drug: Tenapanor

Cohort 3: Phosphate Binder Naive

EXPERIMENTAL

Phosphate binder naive patients are enrolled as Cohort 3 and receive tenapanor with a starting dose of 30 mg/BID

Drug: Tenapanor

Interventions

Tenapanor DRUG

Use of tenapanor

Cohort 1: Straight Switch; Cohort 2: Decrease Phosphate Binder by 50%; Cohort 3: Phosphate Binder Naive

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent form prior to any study specific procedures.
• Males or females aged 18 to 80 years, inclusive, at Screening (Visit 1).
• Females must be non-pregnant and non-lactating.
• 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.
• Kt/V ≥1.2 at most recent measurement prior to Screening (Visit 1).
• 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.
• 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.
• For phosphate binder naïve patients, the s-P level at Screening (Visit 1) must be \>4.5 and ≤10.0 mg/dL.
• Able to understand and comply with the protocol.

You may not qualify if:

• 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).
• Serum/plasma PTH \>1200 pg/mL. The most recent value from the patient's medical records should be used.
• Clinical signs of hypovolemia at Screening (Visit 1) as judged by the Investigator.
• History of inflammatory bowel disease or irritable bowel syndrome with diarrhea.
• Scheduled for living donor kidney transplant or plans to relocate to another center during the study.
• Use of an investigational agent within 30 days prior to Screening (Visit 1).
• 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).
• 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.

Sponsors & Collaborators

• Ardelyx: lead

Study Sites (1)

South Florida Research Institute

Lauderdale Lakes, Florida, 33313, United States

Location

Related Publications (2)

• 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.

  PMID: 38323855 DERIVED

• Silva AL, Chertow GM, Hernandez GT, Lynn RI, Tietjen DP, Rosenbaum DP, Yang Y, Edelstein S. Tenapanor Improves Long-Term Control of Hyperphosphatemia in Patients Receiving Maintenance Dialysis: the NORMALIZE Study. Kidney360. 2023 Nov 1;4(11):1580-1589. doi: 10.34067/KID.0000000000000280. Epub 2023 Oct 19.

  PMID: 37853560 DERIVED

MeSH Terms

Conditions

Hyperphosphatemia

Interventions

tenapanor

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

This was an open label study

Results Point of Contact

• Title: David Rosenbaum
• Organization: Ardelyx

drosenbaum@ardelyx.com

6175134929

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: November 20, 2020
• Primary Completion: October 13, 2021
• Study Completion: December 1, 2021
• Last Updated: March 29, 2023
• Results First Posted: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)