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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ILY101 | Drug |
Inclusion Criteria:
Exclusion Criteria:
Additional study entry criteria will be evaluated during initial screening.
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| Name | Affiliation | Role |
|---|---|---|
| Guido Smeets, MD | Ilypsa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Study Site | Mobile | Alabama | United States | |||
| Clinical Study Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Mountain View |
| California |
| United States |
| Clinical Study Site | Riverside | California | United States |
| Clinical Study Site | San Diego | California | United States |
| Clinical Study Site | Thornton | Colorado | United States |
| Clinical Study Site | Ocala | Florida | United States |
| Clinical Study Site | Palm Beach Gardens | Florida | United States |
| Clinical Study Site | Pembroke Pines | Florida | United States |
| Clinical Study Site | Des Moines | Iowa | United States |
| Clinical Study Site | Baton Rouge | Louisiana | United States |
| Clinical Study Site | Rochester | New York | United States |
| Clinical Study Site | Allentown | Pennsylvania | United States |
| Clinical Study Site | Houston | Texas | United States |
| Clinical Study Site | San Antonio | Texas | United States |
| Clinical Study Site | Provo | Utah | United States |
| Clinical Study Site | Salt Lake City | Utah | United States |
| Clinical Study Site | Norfolk | Virginia | United States |
| Clinical Study Site | Appleton | Wisconsin | 54911 | United States |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D051437 | Renal Insufficiency |
| D054559 | Hyperphosphatemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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