Status:
COMPLETED
EPIC(Effect of PhosLo on Phosphorus Levels in Chronic Kidney Disease)
Lead Sponsor:
Nabi Biopharmaceuticals
Conditions:
Hyperphosphatemia
Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if calcium acetate (PhosLo) can control serum phosphorus in pre-dialysis patients with moderate to severe impairment of kidney function.
Detailed Description
In patients with impaired kidney function, dietary phosphorus can not be completely excreted, which leads to elevated levels of serum phosphorus. Elevated serum phosphorus leads to increased levels of...
Eligibility Criteria
Inclusion
- Non-dialyzed male or female patients with CKD, with a GFR of less than 30mL/min/1.73m² who have elevated serum phosphorus or who develop elevated serum phosphorus following washout from phosphorus-binding therapy.
- Patients must have written informed consent
- Negative serum pregnancy test if appropriate
- Expected to be able to comply with protocol procedures and schedule
Exclusion
- Unstable angina pectoris
- Severe congestive heart failure
- Severe liver dysfunction
- Severe malnutrition
- Severe hyperparathyroidism
- AIDS (HIV positive subjects without AIDS are not excluded)
- Active malignancy for which the subject is receiving chemotherapy or radiation
- Subject unlikely to complete the study
- History of obstructed bowels or hypersensitivity to any of the study medications or their components
- History of swallowing disorders such as dysphagia (that would prevent the subject from taking the study drug) severe gastrointestinal motility disorders, or major GI tract surgery
- Participation in an investigational drug or device trial within 30 days of randomization
- Subjects on Vitamin D therapy
- Subjects with acute symptoms, in the last month, or current radiographic evidence of kidney stones
- Subjects who have undergone renal transplant or receiving dialysis
- Or any condition with makes patient participation not in the patients best interest
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00211978
Start Date
May 1 2005
End Date
October 1 2006
Last Update
January 8 2008
Active Locations (1)
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1
University of Texas Health Sciences Center
San Antonio, Texas, United States, 78229-3900