Status:
COMPLETED
CARE-2 (Calcium Acetate [PhosLo®]/Sevelamer[Renagel®] Evaluation Study 2) for Heart Calcification in Dialysis Patients
Lead Sponsor:
Nabi Biopharmaceuticals
Conditions:
Calcinosis
Arteriosclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 b...
Detailed Description
Cardiovascular disease is the major cause of death and disability in patients with end-stage renal disease on hemodialysis. It has been hypothesized that ingestion of calcium-based phosphate binders r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT00211939
Start Date
January 1 2005
End Date
March 1 2007
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