Clinical trial NCT00358046: Efficacy and Tolerability of ILY101 in Dialysis Patients With Hyperphosphatemia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Kidney Diseases
Renal Insufficiency
Keywords: Hyperphosphatemia
Chronic kidney disease
Dialysis
Hyperphosphatemia in CKD patients on dialysis
Lead sponsor: Ilypsa
Sponsor class: INDUSTRY
First posted: 2006-07-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Clinical Study Site
state: Alabama
city: Mountain View
country: United States
facility: Clinical Study Site
state: California
city: Riverside
country: United States
facility: Clinical Study Site
state: California
city: San Diego
country: United States
facility: Clinical Study Site
state: California
city: Thornton
country: United States
facility: Clinical Study Site
state: Colorado
city: Ocala
country: United States
facility: Clinical Study Site
state: Florida
city: Palm Beach Gardens
country: United States
facility: Clinical Study Site
state: Florida
city: Pembroke Pines
country: United States
facility: Clinical Study Site
state: Florida
city: Des Moines
country: United States
facility: Clinical Study Site
state: Iowa
city: Baton Rouge
country: United States
facility: Clinical Study Site
state: Louisiana
city: Rochester
country: United States
facility: Clinical Study Site
state: New York
city: Allentown
country: United States
facility: Clinical Study Site
state: Pennsylvania
city: Houston
country: United States
facility: Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: Clinical Study Site
state: Texas
city: Provo
country: United States
facility: Clinical Study Site
state: Utah
city: Salt Lake City
country: United States
facility: Clinical Study Site
state: Utah
city: Norfolk
country: United States
facility: Clinical Study Site
state: Virginia
city: Appleton
country: United States
facility: Clinical Study Site
state: Wisconsin
Study officials:
affiliation: Ilypsa
name: Guido Smeets, MD
role: STUDY_DIRECTOR
References: