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

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nabi Biopharmaceuticals
• Treatments: Calcium; Calcium acetate

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