Efficacy and Tolerability of ILY101 in Dialysis Patients With Hyperphosphatemia
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| ClinicalTrials.gov Identifier: NCT00358046 |
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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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Sponsor:
Ilypsa
Information provided by:
Ilypsa
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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 |
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 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Kidney Diseases
U.S. FDA Resources
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| 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.
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
| 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 |
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00358046 History of Changes |
| 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:
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Hyperphosphatemia Chronic kidney disease Dialysis Hyperphosphatemia in CKD patients on dialysis |
Additional relevant MeSH terms:
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Kidney Diseases Renal Insufficiency, Chronic Renal Insufficiency Hyperphosphatemia |
Urologic Diseases Phosphorus Metabolism Disorders Metabolic Diseases |