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Efficacy and Tolerability of ILY101 in Dialysis Patients With Hyperphosphatemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00358046
Recruitment Status : Unknown
Verified February 2007 by Ilypsa.
Recruitment status was:  Active, not recruiting
First Posted : July 28, 2006
Last Update Posted : February 7, 2007
Sponsor:
Information provided by:
Ilypsa

Study Description
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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.

Condition or disease Intervention/treatment Phase
Kidney Diseases Renal Insufficiency Drug: ILY101 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
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 Start Date : June 2006

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358046


Locations
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United States, Alabama
Clinical Study Site
Mobile, Alabama, United States
United States, California
Clinical Study Site
Mountain View, California, United States
Clinical Study Site
Riverside, California, United States
Clinical Study Site
San Diego, California, United States
United States, Colorado
Clinical Study Site
Thornton, Colorado, United States
United States, Florida
Clinical Study Site
Ocala, Florida, United States
Clinical Study Site
Palm Beach Gardens, Florida, United States
Clinical Study Site
Pembroke Pines, Florida, United States
United States, Iowa
Clinical Study Site
Des Moines, Iowa, United States
United States, Louisiana
Clinical Study Site
Baton Rouge, Louisiana, United States
United States, New York
Clinical Study Site
Rochester, New York, United States
United States, Pennsylvania
Clinical Study Site
Allentown, Pennsylvania, United States
United States, Texas
Clinical Study Site
Houston, Texas, United States
Clinical Study Site
San Antonio, Texas, United States
United States, Utah
Clinical Study Site
Provo, Utah, United States
Clinical Study Site
Salt Lake City, Utah, United States
United States, Virginia
Clinical Study Site
Norfolk, Virginia, United States
United States, Wisconsin
Clinical Study Site
Appleton, Wisconsin, United States, 54911
Sponsors and Collaborators
Ilypsa
Investigators
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Study Director: Guido Smeets, MD Ilypsa
More Information
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00358046    
Other Study ID Numbers: ILY-1201
First Posted: July 28, 2006    Key Record Dates
Last Update Posted: February 7, 2007
Last Verified: February 2007
Keywords provided by Ilypsa:
Hyperphosphatemia
Chronic kidney disease
Dialysis
Hyperphosphatemia in CKD patients on dialysis
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency
Hyperphosphatemia
 Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases