Efficacy and Tolerability of ILY101 in Dialysis Patients With Hyperphosphatemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Ilypsa.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ilypsa
ClinicalTrials.gov Identifier:
NCT00358046
First received: July 26, 2006
Last updated: February 5, 2007
Last verified: February 2007
  Purpose

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 Intervention Phase
Kidney Diseases
Renal Insufficiency
Drug: ILY101
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by Ilypsa:

Estimated Enrollment: 120
Study Start Date: June 2006
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358046

Locations
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
Study Director: Guido Smeets, MD Ilypsa
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00358046     History of Changes
Other Study ID Numbers: ILY-1201
Study First Received: July 26, 2006
Last Updated: February 5, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Ilypsa:
Hyperphosphatemia
Chronic kidney disease
Dialysis
Hyperphosphatemia in CKD patients on dialysis

Additional relevant MeSH terms:
Hyperphosphatemia
Kidney Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Metabolic Diseases
Phosphorus Metabolism Disorders
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014