CARE-2 (Calcium Acetate [PhosLo®]/Sevelamer[Renagel®] Evaluation Study 2) for Heart Calcification in Dialysis Patients

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the effects of two phosphate binders, PhosLo and sevelamer, on heart calcification in dialysis patients. The study will use a non-invasive technique, electron beam computed tomography (CT) scanning, to measure calcium in the coronary arteries, the aortic valve, and the mitral valve.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nabi Biopharmaceuticals
• Treatments: Atorvastatin; Atorvastatin Calcium; Calcium; Calcium acetate; Calcium, Dietary; Sevelamer

Criteria

Inclusion Criteria:

• Eligible subjects will be male or female patients with end-stage renal disease on maintenance hemodialysis for less than 5 years, with elevated LDL cholesterol

• Currently treated with oral phosphate binders

• Coronary artery calcium scores of 30 to 5000 Agatston units measured by electron beam CT scanning

• Written informed consent

• Negative serum pregnancy test if appropriate

• Expect to comply with protocol procedures and schedule

Exclusion Criteria:

• Unstable angina pectoris

• Severe congestive heart failure

• Severe obstructive pulmonary disease requiring supplemental oxygen

• Severe liver dysfunction

• Severe malnutrition

• Severe hyperparathyroidism

• Known HIV

• Active malignancy for which the subject is receiving chemotherapy or radiation

• Planned renal transplant within the next year

• Clinical evidence of calciphylaxis or recent history of hypercalcemia

• History of obstructed bowels

• Hypersensitivity to any of the components of the study medication

• History of swallowing disorders

• Weight > 300 pounds

• Any condition which makes patient participation not in the patient's best interest