Chronic Kidney Disease Requiring Chronic Dialysis

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

NCT01324128 | PHASE 3 | INTERVENTIONAL

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.

1059 Participants

Recruiting

18 Years to 65 Years

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Study 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

Additional Studies

Additional studies can be found at ClinicalTrials.gov