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

This study has been completed.

Study NCT00379899 Information provided by Amgen

First Received on September 21, 2006. Last Updated on January 20, 2011 History of Changes

Results First Received: October 1, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Chronic Kidney Disease End Stage Renal Disease Coronary Artery Calcification Vascular Calcification Calcification Cardiovascular Disease Chronic Renal Failure Hyperparathyroidism Kidney Disease Nephrology Secondary Hyperparathyroidism
Intervention:	Drug: cinacalcet

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from 27 October 2006 through 2 May 2008

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Cinacalcet	Cinacalcet plus low dose vitamin D
Control	Flexible vitamin D dosing

Participant Flow: Overall Study

	Cinacalcet	Control
STARTED	180	180
COMPLETED	140	140
NOT COMPLETED	40	40
Adverse Event	7	3
Death	10	10
Lost to Follow-up	2	4
Physician Decision	3	4
Withdrawal by Subject	5	5
Ineligibility determined	0	1
Noncompliance	1	1
Parathyroidectomy	0	2
Renal transplantation	5	4
Coronary artery bypass graft	1	1
Other protocol-specified criteria	3	4
Other	3	1

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Cinacalcet	Cinacalcet plus low dose vitamin D
Control	Flexible vitamin D dosing

Baseline Measures

	Cinacalcet	Control	Total
Number of Participants [units: participants]	180	180	360
Age [units: Years] Mean ± Standard Deviation	61.2 ± 12.6	61.8 ± 12.8	61.5 ± 12.7
Gender [units: Participants]
Female	68	85	153
Male	112	95	207
Race/Ethnicity, Customized [units: Participants]
American Indian or Alaska Native	1	0	1
Asian	4	6	10
Black or African American	45	40	85
Hispanic or Latino	11	14	25
Native Hawaiian or Other Pacific Islander	2	0	2
White or Caucasian	116	120	236
Other	1	0	1
Coronary Artery Calcification Score Stratification Factor [units: Participants]
≥30 to 399	67	67	134
≥400 to 999	47	47	94
≥1000	66	66	132

Outcome Measures

Show All Outcome Measures

1. Primary:

Percent Change From Baseline in CAC Score [ Time Frame: Baseline and Week 52 ]

Show Outcome Measure 1

2. Secondary:

Number of Participants Achieving > 15% Progression of CAC. [ Time Frame: 52 weeks ]

Show Outcome Measure 2

3. Secondary:

Absolute Change in PTH [ Time Frame: Baseline and Week 52 ]

Show Outcome Measure 3

4. Secondary:

Change From Baseline in AC Score [ Time Frame: Baseline and Week 52 ]

Show Outcome Measure 4

5. Secondary:

Change From Baseline of the Progression of AVC. [ Time Frame: Baseline and Week 52 ]

Show Outcome Measure 5

6. Secondary:

Percent Change in PTH [ Time Frame: Baseline and Week 52 ]

Show Outcome Measure 6

7. Secondary:

Absolute Change in Calcium [ Time Frame: Baseline and Weeks 44 through 52 ]

Show Outcome Measure 7

8. Secondary:

Percent Change in Calcium [ Time Frame: Baseline and Weeks 44 through 52 ]

Show Outcome Measure 8

9. Secondary:

Absolute Change in Phosphorus [ Time Frame: Baseline and Weeks 44 through 52 ]

Show Outcome Measure 9

10. Secondary:

Percent Change in Phosphorus [ Time Frame: Baseline and Weeks 44 through 52 ]

Show Outcome Measure 10

11. Secondary:

Absolute Change in Ca x P [ Time Frame: Baseline and Weeks 44 through 52 ]

Show Outcome Measure 11

12. Secondary:

Percent Change in Ca x P [ Time Frame: Baseline and Weeks 44 through 52 ]

Show Outcome Measure 12

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436

Publications of Results:

Floege J, Raggi P, Block GA, Torres PU, Csiky B, Naso A, Nossuli K, Moustafa M, Goodman WG, Lopez N, Downey G, Dehmel B, Chertow GM; ADVANCE Study group. Study design and subject baseline characteristics in the ADVANCE Study: effects of cinacalcet on vascular calcification in haemodialysis patients. Nephrol Dial Transplant. 2010 Jun;25(6):1916-23. Epub 2010 Jan 27.

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00379899 History of Changes
Other Study ID Numbers:	20060111
Study First Received:	September 21, 2006
Results First Received:	October 1, 2010
Last Updated:	January 20, 2011
Health Authority:	Australia: Therapeutic Goods Administration European Union: European Medicines Agency United States: Food and Drug Administration United States: Institutional Review Board