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

NCT00211939 | Completed Phase 4

• 1 other identifier: Nabi 6404
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

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 beam computed tomography (CT) scanning, to measure calcium in the coronary arteries, the aortic valve, and the mitral valve.

Conditions

Calcinosis; Arteriosclerosis; Hyperparathyroidism, Secondary

Keywords

PhosLo (Calcium acetate); Renagel (sevelamer, polyallylamine HCL); kidney dialysis; hyperphosphatemia; Kidney failure

Outcome Measures

Primary Outcomes (1)

• electron-beam CT coronary artery calcification AGATSTON score

  change at 12 mo from baseline

Secondary Outcomes (2)

• serum phosphorus

  Days 30-365

• calcium x phosphorus product

  Days 30-365

Study Arms (2)

1

EXPERIMENTAL

PhosLo + atorvastatin

Drug: calcium acetate; Drug: atorvastatin

2

ACTIVE COMPARATOR

Sevelamer + atorvastatin

Drug: sevelamer; Drug: atorvastatin

Interventions

calcium acetate DRUG

667 mg gelcap, 2-4 t.i.d titrated to serum phosphorus level

Also known as: PhosLo

1

sevelamer DRUG

1-3 tablets t.i.d, titrated to serum phosphorus level

Also known as: Renagel

2

atorvastatin DRUG

20 mg PO qD (in PhosLo group), or held until D60 (sevelamer group); titrate by LDL levels and liver function tests

Also known as: Lipitor

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Nabi Biopharmaceuticals: lead

Study Sites (1)

University of Texas Health Sciences Center

San Antonio, Texas, 78229-3900, United States

Location

Related Publications (3)

• Chertow GM, Burke SK, Raggi P; Treat to Goal Working Group. Sevelamer attenuates the progression of coronary and aortic calcification in hemodialysis patients. Kidney Int. 2002 Jul;62(1):245-52. doi: 10.1046/j.1523-1755.2002.00434.x.

  PMID: 12081584 BACKGROUND

• Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

  PMID: 40576086 DERIVED

• Qunibi W, Moustafa M, Muenz LR, He DY, Kessler PD, Diaz-Buxo JA, Budoff M; CARE-2 Investigators. A 1-year randomized trial of calcium acetate versus sevelamer on progression of coronary artery calcification in hemodialysis patients with comparable lipid control: the Calcium Acetate Renagel Evaluation-2 (CARE-2) study. Am J Kidney Dis. 2008 Jun;51(6):952-65. doi: 10.1053/j.ajkd.2008.02.298. Epub 2008 Apr 18.

  PMID: 18423809 DERIVED

MeSH Terms

Conditions

Calcinosis; Arteriosclerosis; Hyperparathyroidism, Secondary; Hyperphosphatemia; Renal Insufficiency

Interventions

calcium acetate; Sevelamer; Atorvastatin

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Phosphorus Metabolism Disorders; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Wajeh Y Qunibi, M.D.

  The University of Texas Health Science Center at San Antonio

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: January 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: March 1, 2007
• Last Updated: January 8, 2008

Record last verified: 2007-12

Locations

US (1)