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CalcinosisPhase 4NCT00211939

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

A Phase 4 study testing calcium acetate, sevelamer and atorvastatin in people with Calcinosis and Arteriosclerosis, run by Nabi Biopharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
calcium acetate, sevelamer and atorvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
1 siteUnited States
Study dates
Jan 2005to Mar 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Unstable angina pectoris
  • Severe congestive heart failure
  • Severe obstructive pulmonary disease requiring supplemental oxygen
  • Severe liver dysfunction
  • Severe malnutrition
  • Severe hyperparathyroidism
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas Health Sciences Center

    San Antonio, Texas, 78229-3900

Other trials in United States

About this study

Official title: CARE-2 (Calcium Acetate (PhosLo®)/Sevelamer(Renagel®) Evaluation Study 2)

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.

Read the 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 results in net positive calcium balance and vascular calcium deposition. Chertow et al. tested the role of ingested calcium in the progression of cardiovascular calcification in the Treat-To-Goal study (Kidney International 62:245, 2002). They reported that patients treated with calcium-based phosphate binders demonstrated progressive cardiovascular calcification, while patients treated with a calcium-free binder, sevelamer, showed stabilization or improvement in calcification scores. However, the protocol did not prohibit intake of supplemental oral calcium in the sevelamer group, which confounded their ability to accurately test the calcium hypothesis. Moreover, due to the cholesterol sequestering activities of sevelamer, the low-density lipoprotein (LDL) cholesterol was lower among sevelamer-treated patients than the calcium treated patients, resulting in a major imbalance in a cardiovascular risk factor. Lowering LDL level reduces progression of CVC and therefore confounds interpretation of the study. Subsequently, it has been reported in the lay press that patients randomized to sevelamer or calcium-based binders in the Dialysis Clinical Outcomes Revisited (DCOR) study have failed to show a difference in mortality or major secondary endpoints (Suki et al., To be presented American Society of Nephrology November 2005). To circumvent these limitations, the CARE-2 study will test the hypothesis that if LDL levels are lowered to a similar level in calcium acetate and sevelamer-treated patients, there will be no difference in the progression of cardiac calcification. CARE-2 will randomize patients with elevated LDL to calcium acetate or sevelamer. Atorvastatin is added to achieve LDL < 70 mg/dL in both treatment groups. The primary endpoint is change in cardiac calcification scores, determined by electron beam scanning after 1 year. Secondary endpoints include the ability of calcium acetate and sevelamer to control phosphorus and meet NKF-K/DOQI guidelines.

Being tested
calcium acetate, sevelamer, atorvastatin
Keywords
PhosLo (Calcium acetate), Renagel (sevelamer, polyallylamine HCL), kidney dialysis, hyperphosphatemia, Kidney failure
Medical subject headings
Calcinosis, Arteriosclerosis, Hyperparathyroidism, Secondary, Hyperphosphatemia, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • calcium acetateDrug

    Also called PhosLo

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

  • sevelamerDrug

    Also called Renagel

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

  • atorvastatinDrug

    Also called Lipitor

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

Study groups in NCT00211939
Study groupRoleWhat they receive
1ExperimentalPhosLo + atorvastatin
Receives: Drug: calcium acetate; Drug: atorvastatin
2Active comparatorSevelamer + atorvastatin
Receives: Drug: sevelamer; Drug: atorvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. electron-beam CT coronary artery calcification AGATSTON score

    Measured: change at 12 mo from baseline

Secondary outcomes (2)

  1. serum phosphorus

    Measured: Days 30-365

  2. calcium x phosphorus product

    Measured: Days 30-365

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2005 (estimated)
  2. Study startJan 2005
  3. Primary completionDec 2006
  4. Study completionMar 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00211939
Sponsor's protocol ID
Nabi 6404
Status last verified
Dec 2007
First submitted
13 Sep 2005
Last updated
8 Jan 2008
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12081584

  • 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.

    PubMed 40576086

  • 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.

    PubMed 18423809

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing calcium acetate, sevelamer and atorvastatin in people with Calcinosis and Arteriosclerosis, run by Nabi Biopharmaceuticals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

electron-beam CT coronary artery calcification AGATSTON score (time frame: change at 12 mo from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00211939, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2008.

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