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SBR759 vs Sevelamer HCl in CKD Patients on Hemodialysis

NCT00704483Phase 2

Key facts

Status: Completed
Start: Jul 2008
Primary completion: Aug 2010
Countries: 13
Sponsor: Novartis
Modality: Polymer-based Nanoparticles, Small Molecules

Drugs: SBR759
Conditions: hyperphosphatemia

Overview

Phase 2, randomised, open-label trial of SBR759 in hyperphosphatemia (4 arms), sponsored by Novartis. Primary endpoint: Responder rates in target serum phosphate levels at 12 weeks. Started Jul 2008; status: completed.

Design

4 arms

Study design: RandomizedOpen-label

SBR759 1g tid
SBR759 starting dose 1g tid, titrated
Sevelamer HCl 0.8g tid
Sevelamer HCl 0.8g tid
SBR759 1.5g tid
SBR759 starting dose 1.5g tid, titrated
Sevelamer HCl 1.6g tid
Sevelamer HCl 1.6g tid

Who it enrols

Adult patients with Chronic Kidney Disease on stable hemodialysis (3x/week) with serum phosphate >= 6.0 mg/dL. Excludes patients with peritoneal dialysis, uncontrolled hyperparathyroidism, hemochromatosis, or clinically significant GI disorders.

Endpoints

Primary

Responder rates in target serum phosphate levels12 weeks

Secondary

Responder rates in target patients with serum calcium-phosphate levels12 months

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