A Clinical Study to Evaluate the Safety, Tolerability and Activity of a New Phosphate Binder (SBR759) in Patients With Chronic Kidney Disease on Hemodialysis

Completed · Phase 1/Phase 2

Conditions studied: Chronic Kidney Disease

In brief

The primary objective of this study is to assess the safety, tolerability and activity of escalating multiple doses of SBR759 in patients with chronic kidney disease on hemodialysis.

Key facts

Study ID

NCT00750295

Run by

Novartis Pharmaceuticals

People needed

60

Starts

2007-02-01

Expected to finish

2008-01-01

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be treated with maintenance hemodialysis and prescribed a phosphate binder.
• A controlled serum phosphorus.
• Constant dose of concomitant medications.
• Women of child bearing potential must be practicing an acceptable form of birth control (i.e. double barrier method - intrauterine device plus condom, spermicidal gel plus condom). All female patients must have a negative pregnancy test at screening in order to be eligible to participate in the study.

You may not qualify if…

• Patient has been hospitalized within 30 days prior to screening or has a surgery scheduled during the study.
• Patient has an unstable medical condition, an active infection, active malignancy (except for basal cell carcinoma of the skin), a history of major GI tract surgery, or a history of hemochromatosis.
• Patient is receiving or has received an investigational drug (or is currently using an investigational device) within 30 days prior to screening.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Novartis Investigator Site — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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