Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

This study has been completed.

Study NCT00042432 Information provided by Amgen

First Received on July 29, 2002. Last Updated on February 4, 2011 History of Changes

Results First Received: November 4, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Conditions:	Secondary Hyperparathyroidism Chronic Renal Insufficiency
Intervention:	Drug: cinacalcet (AMG 073)

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 28 June 2002 through 14 November 2002

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 (AMG 073)	Cinacalcet administered orally once daily with dose titrated starting at 30 mg
Placebo	Placebo administered orally once daily

Participant Flow: Overall Study

	Cinacalcet (AMG 073)	Placebo
STARTED	27	27
COMPLETED	18	20
NOT COMPLETED	9	7
Adverse Event	4	1
Withdrawal by Subject	1	3
Death	0	2
Ineligibility determined	1	0
Initiation of maintenance dialysis	1	1
Other	2	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Cinacalcet (AMG 073)	Cinacalcet administered orally once daily with dose titrated starting at 30 mg
Placebo	Placebo administered orally once daily

Baseline Measures

	Cinacalcet (AMG 073)	Placebo	Total
Number of Participants [units: participants]	27	27	54
Age [units: Years] Mean ± Standard Deviation	60.6 ± 15.5	61.9 ± 15.2	61.2 ± 15.2
Gender [units: Participants]
Female	11	5	16
Male	16	22	38
Race/Ethnicity, Customized [units: Participants]
White	18	13	31
Black	6	10	16
Other	3	4	7
Glomerular Filtration Rate (GFR) Stratification Factor [units: Participants]
GFR ≥ 15 and < 25 ml/min/1.73 m^2	20	19	39
GFR ≥ 25 and ≤ 50 ml/min/1.73 m^2	7	8	15
Intact Parathyroid Hormone (iPTH) [units: pg/mL] Mean ± Standard Deviation	243.3 ± 139.5	236.1 ± 189.5	239.7 ± 164.9

Outcome Measures

Show All Outcome Measures

1. Primary:

Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase [ Time Frame: Efficacy assessment phase (weeks 12-18) ]

Show Outcome Measure 1

2. Secondary:

Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase [ Time Frame: Baseline, efficacy assessment phase (weeks 12-18) ]

Show Outcome Measure 2

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:

Charytan C, Coburn JW, Chonchol M, Herman J, Lien YH, Liu W, Klassen PS, McCary LC, Pichette V. Cinacalcet hydrochloride is an effective treatment for secondary hyperparathyroidism in patients with CKD not receiving dialysis. Am J Kidney Dis. 2005 Jul;46(1):58-67.

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00042432 History of Changes
Other Study ID Numbers:	20010239
Study First Received:	July 29, 2002
Results First Received:	November 4, 2010
Last Updated:	February 4, 2011
Health Authority:	United States: Food and Drug Administration