Phase 3 N=1,059 Randomized Treatment

A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients

Chronic Kidney Disease Requiring Chronic Dialysis

Bottom Line

View on ClinicalTrials.gov: NCT01324128 ↗

Enrolled (actual)

1,059

Serious AEs

17.9%

Results posted

Apr 2014

Primary outcome: Primary: Change in Serum Phosphorus Levels From Week 24 to Week 27 — 0.25; 1.92 mg/dL

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: PA21 (2.5 g tablet containing 500 mg iron) (Drug); Sevelamer carbonate (Drug); PA21-1 (1.25 g tablet containing 250 mg iron) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vifor Pharma
Primary completion: Apr 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Serum Phosphorus Levels From Week 24 to Week 27	0.25; 1.92	—
SECONDARY Change in Serum Phosphorus Levels From Baseline to Week 12	-2.19; -2.45	—

Summary

This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. The primary objective is to establish the efficacy of PA21 for lowering phosphate levels in these patients.

Eligibility Criteria

Inclusion Criteria

Dialysis patients with hyperphosphataemia (≥ 1.94 mmol/L; ≥ 6.0 mg/dL)
Stable dose of phosphate binder
Written informed consent

Exclusion Criteria

Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH)
Other significant medical conditions
Pregnancy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01324128). 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.