EPIC(Effect of PhosLo on Phosphorus Levels in Chronic Kidney Disease)
Hyperphosphatemia, Kidney Failure
About this trial
This is an interventional treatment trial for Hyperphosphatemia focused on measuring PhosLo (Calcium acetate)
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- University of Texas Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
PhosLo
placebo