Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis

Completed · Phase 2

Conditions studied: Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy

In brief

This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis

Key facts

Study ID

NCT00704483

Run by

Novartis Pharmaceuticals

People needed

321

Starts

2008-07-01

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women of at least 18 years old.
• Stable maintenance of renal replacement therapy 3 times per week.
• Controlled Serum phosphate if under phosphate-binder therapy.
• Serum phosphate level ≥ 6.0 mg/dL (> 1.9 mmol/L) prior to study treatment initiation.

You may not qualify if…

• Peritoneal dialysis.
• Parathyroidectomy or transplant scheduled during the study.
• Uncontrolled hyperparathyroidism
• History of hemochromatosis or ferritin > 1000 µg/L.
• Clinically significant GI disorder
• Unstable medical condition other than Chronic Kidney Disease.
• Treated with oral iron.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Novartis — La Mesa, California, United States
• Novartis — Whittier, California, United States
• Novartis — Denver, Colorado, United States
• Novartis — North Chicago, Illinois, United States
• Novartis — Peoria, Illinois, United States
• Novartis — Mishawaka, Indiana, United States
• Novartis — Baltimore, Maryland, United States
• Novartis — Fall River, Massachusetts, United States
• Novartis — Springfield, Massachusetts, United States
• Novartis Investigative Site — Omaha, Nebraska, United States
• Novartis — New York, New York, United States
• Novartis — Winston-Salem, North Carolina, United States
• Novarits — Fargo, North Dakota, United States
• Novartis — Portland, Oregon, United States
• Novartis — Pittsburgh, Pennsylvania, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis — San Antonio, Texas, United States
• Novartis — Fairfax, Virginia, United States
• Novartis — Adelaide, South Australia, Australia
• Novartis — Fitzroy, Victoria, Australia
• Novartis — Parkville, Victoria, Australia
• Novartis — Melbourne, Australia
• Novartis — South Brisbane, Australia
• Novartis — Woolloongabba, Australia
• Novartis — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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