Multiple Dose Study to Evaluate the Safety of Multiple Doses of Denosumab 120 mg in Adults With Severe Chronic Kidney Disease (CKD) and CKD on Dialysis

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Amgen

ClinicalTrials.gov Identifier:

NCT01464931

First received: October 17, 2011

Last updated: January 22, 2016

Last verified: January 2016

History of Changes

Results First Received: December 14, 2015

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Renal Impairment
Intervention:	Drug: Denosumab

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Severe CKD	Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
ESRD	Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.

Participant Flow: Overall Study

	Severe CKD	ESRD
STARTED	16	16
COMPLETED	15	16
NOT COMPLETED	1	0
Withdrawal by Subject	1	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Severe CKD	Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
ESRD	Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
Total	Total of all reporting groups

Baseline Measures

	Severe CKD	ESRD	Total
Number of Participants [units: participants]	16	16	32
Age [units: years] Mean (Standard Deviation)	79.2 (9.5)	65.9 (12.4)	72.5 (12.8)
Gender [units: participants]
Female	9	7	16
Male	7	9	16

Outcome Measures

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1. Primary:

Number of Participants With Clinically Significant Hypocalcemia [ Time Frame: 113 days ]

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2. Secondary:

Number of Participants With Hypocalcemia Determined by CTCAE v.4.0 Criteria [ Time Frame: 113 days ]

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3. Secondary:

Number of Participants With Hypophosphatemia Determined by CTCAE v.4.0 Criteria [ Time Frame: 113 days ]

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4. Secondary:

Number of Participants With Hypomagnesemia Determined by CTCAE v.4.0 Criteria [ Time Frame: 113 days ]

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5. Secondary:

Percent Change From Baseline in Albumin-adjusted Serum Calcium Over Time [ Time Frame: Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113 ]

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6. Secondary:

Percent Change From Baseline in Serum Phosphorus Over Time [ Time Frame: Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113 ]

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7. Secondary:

Percent Change From Baseline in Serum Magnesium Over Time [ Time Frame: Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113 ]

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8. Secondary:

Number of Participants With Adverse Events [ Time Frame: 113 days ]

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9. Secondary:

Maximum Observed Serum Denosumab Concentration (Cmax) [ Time Frame: Days 1 and 29 (predose), and on Days 8, 15, 36, 43, 57, 71, 85, and 113 ]

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10. Secondary:

Time to Maximum Observed Serum Denosumab Concentration (Tmax) [ Time Frame: Days 1 and 29 (predose), and on Days 8, 15, 36, 43, 57, 71, 85, and 113 ]

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11. Secondary:

Area Under the Serum Concentration-time Curve From Time 0 to 4 Weeks (AUC0-4wks) After Dose 1 [ Time Frame: Days 1, 8, 15, and 29 (predose) ]

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12. Secondary:

Area Under the Serum Concentration-time Curve From Time 0 to 12 Weeks (AUC0-12wks) After Dose 2 [ Time Frame: Days 29 (predose), 36, 43, 57, 71, and 85 ]

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13. Secondary:

Percent Change From Baseline in Serum C-Telopeptide Over Time [ Time Frame: Baseline and Days 1 and 29 (predose), and on Days 8, 15, 36, 43, 57, 71, 85, and 113 ]

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14. Secondary:

Number of Participants Who Developed Anti-denosumab Antibodies [ Time Frame: From Day 1 (predose) to Day 113 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
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More Information

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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 multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.

Results Point of Contact:

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

Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT01464931 History of Changes
Other Study ID Numbers:	20101361
Study First Received:	October 17, 2011
Results First Received:	December 14, 2015
Last Updated:	January 22, 2016
Health Authority:	United States: Food and Drug Administration

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