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

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Ferric Compounds

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.