Efficacy and Tolerability of ILY101 in Dialysis Patients With Hyperphosphatemia

Ilypsa

Status and phase

Unknown

Phase 2

Conditions

Kidney Diseases

Renal Insufficiency

Treatments

Drug: ILY101

Study type

Interventional

Funder types

Industry

Identifiers

NCT00358046

ILY-1201

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.