EPIC(Effect of PhosLo on Phosphorus Levels in Chronic Kidney Disease)

Completed · Phase 3 · Has a placebo group

Conditions studied: Hyperphosphatemia, Kidney Failure

In brief

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.

Key facts

Study ID

NCT00211978

Run by

Nabi Biopharmaceuticals

People needed

110

Starts

2005-05-01

Expected to finish

2006-10-01

Last updated by the study team

2008-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Texas Health Sciences Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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