Efficacy and Tolerability of ILY101 in Dialysis Patients With Hyperphosphatemia

Status unconfirmed · Phase 2

Conditions studied: Kidney Diseases, Renal Insufficiency

In brief

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.

Key facts

Study ID

NCT00358046

Run by

Ilypsa

People needed

120

Starts

2006-06-01

Last updated by the study team

2007-02-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• CKD patients on dialysis
• Prior successful use of phosphate binder
• Signed informed consent

You may not qualify if…

• Previous intolerance to polymer-based phosphate binders
• Kidney transplant planned within 3 months
• Pregnant or lactating women, or women of child bearing potential not using an acceptable form of birth control
• Clinically significant liver disease
• History of bowel obstruction or other significant gastrointestinal disorder
• Additional study entry criteria will be evaluated during initial screening.

Where it is running

• Clinical Study Site — Mobile, Alabama, United States
• Clinical Study Site — Mountain View, California, United States
• Clinical Study Site — Riverside, California, United States
• Clinical Study Site — San Diego, California, United States
• Clinical Study Site — Thornton, Colorado, United States
• Clinical Study Site — Ocala, Florida, United States
• Clinical Study Site — Palm Beach Gardens, Florida, United States
• Clinical Study Site — Pembroke Pines, Florida, United States
• Clinical Study Site — Des Moines, Iowa, United States
• Clinical Study Site — Baton Rouge, Louisiana, United States
• Clinical Study Site — Rochester, New York, United States
• Clinical Study Site — Allentown, Pennsylvania, United States
• Clinical Study Site — Houston, Texas, United States
• Clinical Study Site — San Antonio, Texas, United States
• Clinical Study Site — Provo, Utah, United States
• Clinical Study Site — Salt Lake City, Utah, United States
• Clinical Study Site — Norfolk, Virginia, United States
• Clinical Study Site — Appleton, Wisconsin, United States

Full record on ClinicalTrials.gov

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