Phase 3
N=1,559
A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis
Hyperphosphatemia
Bottom Line
View on ClinicalTrials.gov: NCT03427125 ↗Enrolled (actual)
1,559
Serious AEs
13.2%
Results posted
Jun 2023
Primary outcome: Primary: Change in Serum Phosphorus Levels During Placebo Controlled Randomized Withdrawal Period in the Responder Population — 0.43; 1.80 mg/dL — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tenapanor (Drug); Placebo (Drug); Sevelamer Carbonate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ardelyx
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum Phosphorus Levels During Placebo Controlled Randomized Withdrawal Period in the Responder Population |
0.43; 1.80 | <0.0001 sig |
| SECONDARY Change in Serum Phosphorus Levels During Placebo Controlled Randomized Withdrawal Period in the ITT Population |
0.22; 0.88 | 0.0020 sig |
| SECONDARY Serum Phosphorus From Baseline |
7.44; 5.88 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03427125). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.