A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis

Hyperphosphatemia Clinical Trial

Official title:

A 26-Wk, Phase 3, Open Label (OL) Study With a 12-Wk, Placebo-Controlled, Randomized Withdrawal Period and an OL Safety Extension to Evaluate the Safety and Efficacy of Tenapanor to Treat Hyperphosphatemia in CKD Patients on Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03427125
• Other study ID #: TEN-02-301
• Status: Completed
• Phase: Phase 3
• Start date: January 8, 2018
• Est. completion date: February 27, 2020

Study information

• Verified date: June 2023
• Source: Ardelyx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study consists of a screening visit, a phosphate binder-free washout period of up to 4 weeks, a 26-week treatment period, an up to 12-week placebo-controlled, randomized withdrawal period, during which patients are randomized 1:1 to either remain on their tenapanor treatment or placebo, followed by an open label safety extension period for a total treatment period of up to 52 weeks. An active control group, for safety analysis only, will receive sevelamer carbonate, open label, for the entire 52-week study period

Depending on increase in serum phosphate (s-P) levels, subjects can be randomized 2 or 3 weeks after being taken off their phosphate lowering medication.

Subjects who qualify to enroll in the study will be randomized 3:1 to either receive tenapanor at a dose of 30 mg bid or sevelamer carbonate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1559
• Est. completion date: February 27, 2020
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hyperphosphatemia

Intervention

Drug:
• Tenapanor
Active Drug
• Placebo
Inactive Drug
• Sevelamer Carbonate
Active control

Locations

Country	Name	City	State
United States	Site 529	Bronx	New York
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ardelyx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Serum Phosphorus Levels During Placebo Controlled Randomized Withdrawal Period in the ITT Population	Placebo Adjusted Change in Serum Phosphorus from the beginning to the end of the Randomized Withdrawal Period in all patients	12 weeks (randomized withdrawal period)
Secondary	Serum Phosphorus From Baseline	Serum Phosphorus from baseline (post washout) to end of 26 week period	26 weeks (open label treatment period)