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NCT00358046 Clinical Trial

Efficacy and Tolerability of ILY101 in Dialysis Patients With Hyperphosphatemia

Kidney Diseases Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00358046
Other study ID # ILY-1201
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received July 26, 2006
Last updated February 5, 2007
Start date June 2006

Study information
Verified date February 2007
Source Ilypsa
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 120
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- CKD patients on dialysis

- Prior successful use of phosphate binder

- Signed informed consent

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ILY101

Locations
Country Name City State
United States Clinical Study Site Allentown Pennsylvania
United States Clinical Study Site Appleton Wisconsin
United States Clinical Study Site Baton Rouge Louisiana
United States Clinical Study Site Des Moines Iowa
United States Clinical Study Site Houston Texas
United States Clinical Study Site Mobile Alabama
United States Clinical Study Site Mountain View California
United States Clinical Study Site Norfolk Virginia
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 Provo Utah
United States Clinical Study Site Riverside California
United States Clinical Study Site Rochester New York
United States Clinical Study Site Salt Lake City Utah
United States Clinical Study Site San Antonio Texas
United States Clinical Study Site San Diego California
United States Clinical Study Site Thornton Colorado

Sponsors (1)
Lead Sponsor Collaborator
Ilypsa

Country where clinical trial is conducted

United States, 

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