Status:
UNKNOWN
Efficacy and Tolerability of ILY101 in Dialysis Patients With Hyperphosphatemia
Lead Sponsor:
Ilypsa
Conditions:
Kidney Diseases
Renal Insufficiency
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 we...
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 rena...
Eligibility Criteria
Inclusion
- CKD patients on dialysis
- Prior successful use of phosphate binder
- Signed informed consent
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00358046
Start Date
June 1 2006
Last Update
February 7 2007
Active Locations (18)
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1
Clinical Study Site
Mobile, Alabama, United States
2
Clinical Study Site
Mountain View, California, United States
3
Clinical Study Site
Riverside, California, United States
4
Clinical Study Site
San Diego, California, United States