Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
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
  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
No text entered.

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
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
  Hide Baseline Characteristics

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.
No text entered.

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
  Show All Outcome Measures

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

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

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

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

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 ]

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 ]

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 ]

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

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 ]

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 ]

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) ]

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 ]

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 ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  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:
unchecked 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.
unchecked 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.


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