Efficacy and Tolerability of ILY101 in Dialysis Patients With Hyperphosphatemia
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Kidney Diseases Renal Insufficiency | Drug: ILY101 | Phase 2 |
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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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, Alabama | |
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Mobile, Alabama, United States | |
United States, California | |
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Mountain View, California, United States | |
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Riverside, California, United States | |
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San Diego, California, United States | |
United States, Colorado | |
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Thornton, Colorado, United States | |
United States, Florida | |
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Ocala, Florida, United States | |
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Palm Beach Gardens, Florida, United States | |
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Pembroke Pines, Florida, United States | |
United States, Iowa | |
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Des Moines, Iowa, United States | |
United States, Louisiana | |
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Baton Rouge, Louisiana, United States | |
United States, New York | |
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Rochester, New York, United States | |
United States, Pennsylvania | |
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Allentown, Pennsylvania, United States | |
United States, Texas | |
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Houston, Texas, United States | |
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San Antonio, Texas, United States | |
United States, Utah | |
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Provo, Utah, United States | |
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Salt Lake City, Utah, United States | |
United States, Virginia | |
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Norfolk, Virginia, United States | |
United States, Wisconsin | |
Clinical Study Site | |
Appleton, Wisconsin, United States, 54911 |
Study Director: | Guido Smeets, MD | Ilypsa |
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 |
Hyperphosphatemia Chronic kidney disease Dialysis Hyperphosphatemia in CKD patients on dialysis |
Kidney Diseases Renal Insufficiency Hyperphosphatemia |
Urologic Diseases Phosphorus Metabolism Disorders Metabolic Diseases |