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ASP1585 in CKD patients with hyperphosphatemia

NCT01742585Phase 3

Key facts

Status: Completed
Start: Oct 2012
Primary completion: May 2014
Countries: 1
Sponsor: Astellas Pharma
Modality: Polymer-based Nanoparticles, Small Molecules

Drugs: bixalomer
Conditions: hyperphosphatemia

Overview

Phase 3, randomised, double-blind trial in hyperphosphatemia comparing ASP1585 with Placebo (2 arms). Primary endpoint: Change from baseline in serum phosphorus level at the end of treatment at 12 weeks. Started Oct 2012; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

ASP1585
ASP1585 (bixalomer) oral administration
Placebo
Placebo oral administration

Who it enrols

Patients with CKD (eGFR < 60) and hyperphosphatemia (Serum P 4.6-9.0 mg/dL), excluding those with GI surgery, severe cardiac disease, severe constipation/diarrhea, or recent parathyroid intervention.

Endpoints

Primary

Change from baseline in serum phosphorus level at the end of treatment12 weeks

Secondary

Achievement rate of the target range of serum phosphorus level12 weeks
Time to achieve the target range of serum phosphorus level12 weeks
Time-course changes in serum phosphorus levels12 weeks
Time-course changes in serum calcium levels12 weeks
Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs12 weeks

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