NCT00358046

Efficacy and Tolerability of ILY101 in Dialysis Patients With Hyperphosphatemia

A Phase 2, Randomized, Dose-Ranging, Single-Blind, Efficacy and Tolerability Study of ILY101 in Patients With Chronic Kidney Disease With Hyperphosphatemia on Hemodialysis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (planned)
• Sponsor: Ilypsa · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, dose-ranging, efficacy and tolerability study in chronic kidney disease patients with hyperphosphatemia on hemodialysis. Patient participation in the study is approximately 10 weeks in duration.

Detailed description

Hyperphosphatemia is associated with abnormally high blood concentrations of phosphorus. Normally, phosphorus in the body is excreted into urine via the kidneys, but this process is impaired when renal function is reduced. Hyperphosphatemia occurs in many patients with renal insufficiency, especially those on dialysis. High blood phosphorus concentrations trigger various complications caused by phosphorous interaction with blood calcium or parathyroid hormones, and makes patients more prone to calcium deposition in soft tissues such as the coronary arteries, increasing the risk of ischemic heart disease. ILY101 is a non-absorbed, metal-free polymer that binds phosphorus in the gastrointestinal tract, allowing for excretion of phosphorus. It is therefore anticipated to ameliorate hyperphosphatemia by reducing the absorption of phosphorus from the gastrointestinal tract.

Conditions

• Kidney Diseases
• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	ILY101

Timeline

• Start date: 2006-06-01
• First posted: 2006-07-28
• Last updated: 2007-02-07

Locations

18 sites across 1 country: United States