CARE-2 (Calcium Acetate [PhosLo®]/Sevelamer[Renagel®] Evaluation Study 2) for Heart Calcification in Dialysis Patients
Completed · Phase 4
Conditions studied: Calcinosis, Arteriosclerosis, Hyperparathyroidism, Secondary
In brief
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.
Key facts
- Study ID
- NCT00211939
- Run by
- Nabi Biopharmaceuticals
- People needed
- 203
- Starts
- 2005-01-01
- Expected to finish
- 2007-03-01
- 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…
- 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
You may not qualify if…
- 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
Where it is running
- University of Texas Health Sciences Center — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.