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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00358046

Enrollment

120

Registered

2006-07-28

Start date

2006-06-30

Completion date

Unknown

Last updated

2007-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Diseases, Renal Insufficiency

Keywords

Hyperphosphatemia, Chronic kidney disease, Dialysis, Hyperphosphatemia in CKD patients on dialysis

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.

Interventions

DRUGILY101

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026