ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis

July 14, 2014 updated by: Amgen

A Randomized Study to Evaluate the Effects of Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease (CKD) Receiving Hemodialysis

The purpose of this study is to evaluate whether cinacalcet + low dose vitamin D attenuates the progression of vascular calcification over one year, compared with a treatment regimen that includes flexible vitamin D dosing in the absence of cinacalcet, in subjects with chronic kidney disease receiving hemodialysis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults with chronic kidney disease receiving hemodialysis.
  • Lab tests required at screening include Parathyroid Hormone (PTH), calcium, and phosphorus.
  • A screening coronary artery calcification score of at least 30.

Exclusion Criteria:

  • Subjects on non-calcium or aluminum containing phosphate binders (example: sevelamer HCl, lanthanum) 30 days prior to screening.
  • Subjects on cinacalcet 30 days prior to screening.
  • Current or previous use of some osteoporosis medications.
  • Started or required change in cholesterol lowering medications within 30 days before screening.
  • Abnormal rhythm of the heart.
  • Parathyroidectomy done within 3 months prior to screening.
  • Anticipated parathyroidectomy or kidney transplant.
  • Current intolerance to oral medications, or inability to swallow.
  • Unstable medical condition.
  • Currently enrolled, or fewer than 30 days have passed since subject used another investigational device or drug.
  • Pregnancy or breast feeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Standard of care, without use of cinacalcet.
Drug: cinacalcet
Low dose vitamin D with cinacalcet
Other Names:
  • cinacalcet + low dose vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in CAC Score
Time Frame: Baseline and Week 52
Percent Change from baseline to week 52 in coronary artery calcification (CAC) score. CAC score ranges from 0 to 7500, with 0 representing no calcification.
Baseline and Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Achieving > 15% Progression of CAC.
Time Frame: 52 weeks
Number of participants achieving >15% progression of coronary artery calcification (CAC) at week 52
52 weeks
Absolute Change in PTH
Time Frame: Baseline and Week 52
Absolute change from baseline in intact Parathyroid Hormone (iPTH)
Baseline and Week 52
Change From Baseline in AC Score
Time Frame: Baseline and Week 52
Change from baseline in aortic calcification (AC) score at week 52. AC score ranges from 0 to >75,000, with 0 representing no calcification.
Baseline and Week 52
Change From Baseline of the Progression of AVC.
Time Frame: Baseline and Week 52
Change from baseline in the aortic valve calcification (AVC) score. AVC score ranges from 0 to >10,000, with 0 representing no calcification.
Baseline and Week 52
Percent Change in PTH
Time Frame: Baseline and Week 52
Percent change from baseline in intact Parathyroid Hormone (iPTH)
Baseline and Week 52
Absolute Change in Calcium
Time Frame: Baseline and Weeks 44 through 52
Absolute change from baseline in serum calcium to weeks 44 through 52
Baseline and Weeks 44 through 52
Percent Change in Calcium
Time Frame: Baseline and Weeks 44 through 52
Percent change from baseline in corrected serum calcium to weeks 44 through 52
Baseline and Weeks 44 through 52
Absolute Change in Phosphorus
Time Frame: Baseline and Weeks 44 through 52
Absolute change from baseline in serum phosphorus to weeks 44 through 52
Baseline and Weeks 44 through 52
Percent Change in Phosphorus
Time Frame: Baseline and Weeks 44 through 52
Percent change from baseline in serum phosphorus to weeks 44 through 52
Baseline and Weeks 44 through 52
Absolute Change in Ca x P
Time Frame: Baseline and Weeks 44 through 52
Absolute change from baseline in corrected serum calcium x phosphorus to week 44 through week 52
Baseline and Weeks 44 through 52
Percent Change in Ca x P
Time Frame: Baseline and Weeks 44 through 52
Percent change from baseline in corrected serum calcium x phosphorus (Ca x P) to weeks 44 through 52
Baseline and Weeks 44 through 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

September 21, 2006

First Submitted That Met QC Criteria

September 21, 2006

First Posted (Estimate)

September 25, 2006

Study Record Updates

Last Update Posted (Estimate)

July 23, 2014

Last Update Submitted That Met QC Criteria

July 14, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20060111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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