NCT03988920

Brief Summary

The study is designed to evaluate the ability of tenapanor alone or in combination with sevelamer to achieve serum phosphorus concentration (sP) within the population reference range (sP \>2.5 and ≤4.5 mg/dL) in patients with end-stage renal disease (ESRD) on dialysis with hyperphosphatemia (\>4.5 mg/dL).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2019

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

June 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 29, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

June 14, 2019

Results QC Date

March 3, 2023

Last Update Submit

March 3, 2023

Conditions

HyperphosphatemiaEnd Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

  • Achieving Normal Serum Phosphorus Level

    Proportion of patients with serum phosphorus between 2.5 and 4.5 mg/dL

    18 months

Secondary Outcomes (2)

  • Change in Serum Phosphorus (s-P) From TEN-02-301 (Parent Study) Baseline

    up to 2.5 years

  • Change From Baseline in Serum Phosphorus (of Extension Study; TEN-02-401) to Endpoint Visit

    up to 18 months

Study Arms (2)

Tenapanor w/Sevelamer

EXPERIMENTAL

Tenapanor will be administered QD or BID and sevelamer can be added to achieve desired serum phosphorus level

Drug: TenapanorDrug: Sevelamer Carbonate

Sevelamer w/Tenapanor

EXPERIMENTAL

Sevelamer will be administered QD, BID or TID and tenapanor will be added to achieve desired serum phosphorus level and sevelamer dose will be decreased as needed

Drug: TenapanorDrug: Sevelamer Carbonate

Interventions

TenapanorDRUG

NHE3 Inhibitor

Sevelamer w/TenapanorTenapanor w/Sevelamer
Sevelamer CarbonateDRUG

Phosphate binder

Sevelamer w/TenapanorTenapanor w/Sevelamer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Must complete TEN-02-301 (PHREEDOM)

You may not qualify if:

  • Schedlued for kidney transplant
  • Life expectancy \<12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ardelyx Site #509

Houston, California, 77099, 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: 38323855DERIVED

  • 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: 37853560DERIVED

MeSH Terms

Conditions

HyperphosphatemiaKidney Failure, Chronic

Interventions

tenapanorSevelamer

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PolyaminesAminesOrganic Chemicals

Results Point of Contact

Title
Chief Development Officer
Organization
Ardelyx
drosenbaum@ardelyx.com
6175134929

Study Officials

  • David P Rosenbaum, PhD

    Ardelyx

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

June 14, 2019

First Posted

June 18, 2019

Study Start

June 15, 2019

Primary Completion

June 26, 2021

Study Completion

July 31, 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)