Clinical Trial: Study to Evaluate the Efficacy and Safety of PT20 in Subjects With Hyperphosphataemia and Dialysis Dependent Chronic Kidney Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Study to Evaluate the Efficacy and Safety of PT20 in Subjects With Hyperphosphataemia and Dialysis Dependent Chronic Kidney Disease
Brief Summary: The main purpose of this study is to see whether PT-20 can help people with a high level of phosphate in their blood (called Hyperphosphatemia) that are being treated with dialysis for kidney disease.
Detailed Summary: Elevated serum phosphate is a ubiquitous complication of reduced kidney function and evidence suggests that this metabolic disturbance is associated with cardiovascular morbidity and mortality in subjects receiving haemodialysis Efforts to achieve normal serum phosphate with dietary restrictions, thrice weekly dialysis and phosphate binders have failed to substantially improve the achieved serum phosphate levels. Data from a large international practice pattern study suggest that approximately 50% of all dialysis subjects have serum phosphate above the recommended target value of 5.5 mg/dL The standard of care for phosphate control remains the prescription of phosphate binders with meals. These drugs act in the small intestine to bind phosphate and prevent its absorption into the bloodstream. The 2 general categories of phosphate binders currently commercially available include calcium containing phosphate binders (calcium carbonate and calcium acetate) and the non calcium containing phosphate binders (sevelamer carbonate and lanthanum carbonate While these 2 classes of phosphate binders have similar efficacy, they differ substantially in their associated side effects.
Sponsor: Phosphate Therapeutics
Current Primary Outcome: To assess the effect of oral PT20 over placebo on serum phosphate [ Time Frame: Day 28 of Dosing ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- • To assess the safety and tolerability of PT20 utilising adverse events (AEs), discontinuations from study medication and laboratory values. [ Time Frame: Day 1 to Day 28 of dosing ]
- • To assess gastrointestinal effects using the gastrointestinal symptom rating scale (GSRS). [ Time Frame: Day 1 to Day 28 Dosing ]
Original Secondary Outcome: Same as current
Information By: Phosphate Therapeutics
Dates:
Date Received: May 28, 2014
Date Started: May 2014
Date Completion:
Last Updated: October 20, 2015
Last Verified: October 2015
