Efficacy and Tolerability of ILY101 in Dialysis Patients With Hyperphosphatemia

NCT ID: NCT00358046

Last Updated: 2007-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Brief Summary

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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

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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.

Conditions

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Kidney Diseases Renal Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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ILY101

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ilypsa

INDUSTRY

Sponsor Role lead

Principal Investigators

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Guido Smeets, MD

Role: STUDY_DIRECTOR

Ilypsa

Locations

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Clinical Study Site

Mobile, Alabama, United States

Site Status

Clinical Study Site

Mountain View, California, United States

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Clinical Study Site

Riverside, California, United States

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San Diego, California, United States

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Clinical Study Site

Thornton, Colorado, United States

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Clinical Study Site

Ocala, Florida, United States

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Clinical Study Site

Palm Beach Gardens, Florida, United States

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Clinical Study Site

Pembroke Pines, Florida, United States

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Clinical Study Site

Des Moines, Iowa, United States

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Clinical Study Site

Baton Rouge, Louisiana, United States

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Clinical Study Site

Rochester, New York, United States

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Clinical Study Site

Allentown, Pennsylvania, United States

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Clinical Study Site

Houston, Texas, United States

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Clinical Study Site

San Antonio, Texas, United States

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Clinical Study Site

Provo, Utah, United States

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Clinical Study Site

Salt Lake City, Utah, United States

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Clinical Study Site

Norfolk, Virginia, United States

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Clinical Study Site

Appleton, Wisconsin, United States

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Countries

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United States

Related Links

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Other Identifiers

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ILY-1201

Identifier Type: -

Identifier Source: org_study_id

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