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Efficacy and Tolerability of ILY101 in Dialysis Patients With Hyperphosphatemia

Primary Purpose

Kidney Diseases, Renal Insufficiency

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ILY101
Sponsored by
Ilypsa
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Diseases focused on measuring Hyperphosphatemia, Chronic kidney disease, Dialysis, Hyperphosphatemia in CKD patients on dialysis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Study Site
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Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 26, 2006
Last Updated
February 5, 2007
Sponsor
Ilypsa
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1. Study Identification

Unique Protocol Identification Number
NCT00358046
Brief Title
Efficacy and Tolerability of ILY101 in Dialysis Patients With Hyperphosphatemia
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 Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Ilypsa

4. Oversight

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases, Renal Insufficiency
Keywords
Hyperphosphatemia, Chronic kidney disease, Dialysis, Hyperphosphatemia in CKD patients on dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ILY101

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido Smeets, MD
Organizational Affiliation
Ilypsa
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Study Site
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
Clinical Study Site
City
Mountain View
State/Province
California
Country
United States
Facility Name
Clinical Study Site
City
Riverside
State/Province
California
Country
United States
Facility Name
Clinical Study Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Clinical Study Site
City
Thornton
State/Province
Colorado
Country
United States
Facility Name
Clinical Study Site
City
Ocala
State/Province
Florida
Country
United States
Facility Name
Clinical Study Site
City
Palm Beach Gardens
State/Province
Florida
Country
United States
Facility Name
Clinical Study Site
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
Clinical Study Site
City
Des Moines
State/Province
Iowa
Country
United States
Facility Name
Clinical Study Site
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Clinical Study Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
Clinical Study Site
City
Allentown
State/Province
Pennsylvania
Country
United States
Facility Name
Clinical Study Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Clinical Study Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Clinical Study Site
City
Provo
State/Province
Utah
Country
United States
Facility Name
Clinical Study Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Clinical Study Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Clinical Study Site
City
Appleton
State/Province
Wisconsin
ZIP/Postal Code
54911
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ilypsa.com
Description
Related Info

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Efficacy and Tolerability of ILY101 in Dialysis Patients With Hyperphosphatemia

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