Phase 3
Completed N=1,059
A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients
Chronic Kidney Disease Requiring Chronic Dialysis
Source: ClinicalTrials.gov NCT01324128 ↗
Enrolled (actual)
1,059
Serious AEs
17.9%
Results posted
Apr 2014
Primary outcomePrimary: Change in Serum Phosphorus Levels From Week 24 to Week 27 — 0.25; 1.92 mg/dL
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.
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 | — |
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
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. Informational only — not medical advice.