Study to Evaluate the Efficacy and Safety of PT20 in Subjects With Hyperphosphataemia and Dialysis Dependent Chronic Kidney Disease

• Status: Completed
• Trial end date: 2015-03-18
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to see whether PT20 can help people with a high level of phosphate in their blood (called Hyperphosphatemia) that are being treated with dialysis for kidney disease.

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

Details

• Lead Sponsor: Phosphate Therapeutics
• Collaborator: Clinipace Worldwide
• Treatments: Iron

Criteria

Inclusion Criteria:

• Men or women aged 18 90 years

• Subject must have a stable dialysis prescription for at least 28 days prior to start of Screening.

• Subject must have the most recent serum phosphate measurement, taken during the 28 days prior to the start of Screening, of ≥ 4.0 mg/dL and ≤ 8 mg/dL.

Exclusion Criteria:

• Subject's most recent historical pre-dialysis serum bicarbonate value within 14 days prior to the start of Screening (Visit 1) is < 18 mg/dL.

• Subject has, in the opinion of the investigator, severe chronic lung disease and/or carbon dioxide retention.