Efficacy and Tolerability of ILY101 in Dialysis Patients With Hyperphosphatemia
A Phase 2, Randomized, Dose-Ranging, Single-Blind, Efficacy and Tolerability Study of ILY101 in Patients With Chronic Kidney Disease With Hyperphosphatemia on Hemodialysis
1 other identifier
interventional
120
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 26, 2006
CompletedFirst Posted
Study publicly available on registry
July 28, 2006
CompletedFebruary 7, 2007
February 1, 2007
July 26, 2006
February 5, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- CKD patients on dialysis
- Prior successful use of phosphate binder
- Signed informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ilypsalead
Study Sites (18)
Clinical Study Site
Mobile, Alabama, United States
Clinical Study Site
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Guido Smeets, MD
Ilypsa
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 26, 2006
First Posted
July 28, 2006
Study Start
June 1, 2006
Last Updated
February 7, 2007
Record last verified: 2007-02