NCT03427125

Brief Summary

This Phase 3, 26-week, open label study with a 12-week, placebo-controlled, randomized withdrawal period followed by an open label long term safety extension will evaluate the safety and efficacy of tenapanor to treat hyperphosphatemia in end-stage renal disease (ESRD) on hemodialysis and peritoneal dialysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,559

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

January 8, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2020

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

June 29, 2023

Completed
Last Updated

June 29, 2023

Status Verified

June 1, 2023

Enrollment Period

1.9 years

First QC Date

January 19, 2018

Results QC Date

December 7, 2022

Last Update Submit

June 8, 2023

Conditions

Hyperphosphatemia

Outcome Measures

Primary Outcomes (1)

  • Change in Serum Phosphorus Levels During Placebo Controlled Randomized Withdrawal Period in the Responder Population

    Patients with at least a 1.2 mg/dL decrease in serum phosphorus during the first 26 weeks of the study were defined as the responder population.

    12 weeks (randomized withdrawal period)

Secondary Outcomes (2)

  • Change in Serum Phosphorus Levels During Placebo Controlled Randomized Withdrawal Period in the ITT Population

    12 weeks (randomized withdrawal period)

  • Serum Phosphorus From Baseline

    26 weeks (open label treatment period)

Study Arms (3)

Tenapanor 10 mg, 20 mg, 30 mg BID

EXPERIMENTAL

During the 26-week open label part, all enrolled subjects will receive 30 mg BID doses of tenapanor. Investigators may decrease or increase the dose in 10 mg increments to a minimum of 10 g BIDor a maximum of 30 mg BID

Drug: Tenapanor

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Sevelamer Carbonate

ACTIVE COMPARATOR

Subjects randomized into the active control group, for safety analysis, will receive sevelamer carbonate, open label, for the entire 52-week study period. Sevelamer carbonate will be dosed based on package insert instructions (standard of care)

Drug: Sevelamer Carbonate

Interventions

TenapanorDRUG

Active Drug

Also known as: RDX5791, AZD1722
Tenapanor 10 mg, 20 mg, 30 mg BID
PlaceboDRUG

Inactive Drug

Placebo
Sevelamer CarbonateDRUG

Active control

Also known as: Renvela
Sevelamer Carbonate

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females must be non-pregnant, non-lactating, and either be post-menopausal for at least 12 months, have documentation of irreversible surgical sterilization, or confirm the use of one of the acceptable contraceptive methods
  • Males must agree to avoid fathering a child and agree to use an appropriate method of contraception
  • Chronic maintenance hemodialysis 3x a week for at least 3 months
  • Chronic maintenance peritoneal dialysis for a minimum of 6 months
  • Kt/V ≥ 1.2 at most recent measurement prior to screening
  • Prescribed and taking at least 3 doses of phosphate binder per day
  • Serum phosphorus levels should be between 4.0 and 8.0 mg/dL at screening
  • Unchanged dose of vitamin D or calcimimetics for the last 4 weeks prior to screening
  • For enrollment in the study after at least 2 weeks of wash-out, subjects must have serum phosphorus levels of at least 6.0 mg/dL but not more than 10.0 mg/dL and have had an increase of at least 1.5 mg/dL versus pre-wash out value after 2 or 3 weeks wash-out of phosphate binders

You may not qualify if:

  • Severe hyperphosphatemia defined as serum phosphorus greater than 10.0 mg/dL on phosphate-binders at any time point during clinical routine monitoring for the 3 preceding months before screening visit
  • Serum/plasma parathyroid hormone \>1200 pg/mL
  • Clinical signs of hypovolemia at enrollment
  • History of IBD or IBS-D
  • Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center during the study period
  • Positive serology with evidence of significant hepatic impairment or WBC elevation according to the Investigator
  • Life expectancy \<6 months
  • Previous exposure to tenapanor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Site 529

The Bronx, New York, 10461, United States

Location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (4)

  • Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

    PMID: 40576086DERIVED

  • 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

  • Block GA, Bleyer AJ, Silva AL, Weiner DE, Lynn RI, Yang Y, Rosenbaum DP, Chertow GM. Safety and Efficacy of Tenapanor for Long-term Serum Phosphate Control in Maintenance Dialysis: A 52-Week Randomized Phase 3 Trial (PHREEDOM). Kidney360. 2021 Aug 27;2(10):1600-1610. doi: 10.34067/KID.0002002021. eCollection 2021 Oct 28.

    PMID: 35372979DERIVED

MeSH Terms

Conditions

Hyperphosphatemia

Interventions

tenapanorSevelamer

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

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 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2018

First Posted

February 9, 2018

Study Start

January 8, 2018

Primary Completion

November 15, 2019

Study Completion

February 27, 2020

Last Updated

June 29, 2023

Results First Posted

June 29, 2023

Record last verified: 2023-06

Locations

US(2)