NCT02151643

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Phosphate Therapeutics · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PT20 represents a mechanism to address many of the limitations associated with current phosphate binding agents. The available clinical and non clinical evidence suggests that PT20 binds phosphate and prevents its uptake more efficiently than other phosphate binding drugs and may therefore either reduce the pill burden associated with controlling phosphate levels, or result in lower phosphate levels with the same pill burden. The this study is the first to investigate the efficacy and safety of PT20 in subjects with dialysis-dependent chronic kidney disease (CKD).

Conditions

• Hyperphosphataemia

Interventions

Type	Name	Description
DRUG	PT20	Modified ferric oxide adipate tablets
DRUG	Placebo	Placebo tablets matched to each PT20 dose arm

Timeline

• Start date: 2014-05-07
• Primary completion: 2015-03-18
• Completion: 2015-03-18
• First posted: 2014-05-30
• Last updated: 2018-01-16
• Results posted: 2018-01-16

Regulatory

• FDA-regulated drug study