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Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis

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ClinicalTrials.gov Identifier: NCT01785849
Recruitment Status : Completed
First Posted : February 7, 2013
Results First Posted : March 27, 2017
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Hyperparathyroidism, Secondary
Interventions: Drug: Etelcalcetide
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at 111 centers in the US, Canada, Europe, Israel, Russian Federation, and Australia. The first participant was enrolled on 12 March 2013 and the last participant enrolled on 08 November 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible participants were randomized in a 1:1 ratio to etelcalcetide or placebo. Randomization was stratified by mean screening parathyroid hormone (PTH) (< 600 pg/mL, 600 to ≤ 1000 pg/mL, and > 1000 pg/mL), prior cinacalcet use and region (North America or non-North America).

Reporting Groups
  Description
Placebo Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
Etelcalcetide Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.

Participant Flow:   Overall Study
    Placebo   Etelcalcetide
STARTED   254   254 
Received Treatment   254   251 
COMPLETED   193   220 
NOT COMPLETED   61   34 
Death                7                9 
Protocol Specified Criteria                29                1 
Withdrawal by Subject                15                12 
Sponsor Decision                0                1 
Lost to Follow-up                10                11 



  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
Placebo Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
Etelcalcetide Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
Total Total of all reporting groups

Baseline Measures
   Placebo   Etelcalcetide   Total 
Overall Participants Analyzed 
[Units: Participants]
 254   254   508 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.1  (14.5)   58.4  (14.6)   57.7  (14.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      114  44.9%      103  40.6%      217  42.7% 
Male      140  55.1%      151  59.4%      291  57.3% 
Race 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   3   5   8 
Black (or African American)   69   72   141 
Native Hawaiian or Other Pacific Islander   2   0   2 
White   175   173   348 
Other   4   4   8 
Missing   1   0   1 
Stratification Factor: Mean Screening Serum Parathyroid Hormone (PTH) [1] 
[Units: Participants]
     
< 600 pg/mL   84   87   171 
≥ 600 to ≤ 1000 pg/mL   114   115   229 
> 1000 pg/mL   56   52   108 
[1] Mean screening parathyroid hormone (PTH) obtained within 2 weeks prior to randomization.
Stratification Factor: Cinacalcet Use Within 8 Weeks of Randomization 
[Units: Participants]
     
Yes   34   33   67 
No   220   221   441 
Stratification Factor: Region 
[Units: Participants]
     
North America   129   132   261 
Non-North America   125   122   247 
Parathyroid Hormone (PTH) 
[Units: pg/mL]
Mean (Standard Deviation)
 819.7  (386.0)   848.7  (520.4)   834.2  (457.9) 
Phosphorus [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 5.78  (1.60)   5.95  (1.59)   5.87  (1.59) 
[1] Data were available for 250 subjects in each treatment group.
Corrected Calcium 
[Units: mg/dL]
Mean (Standard Deviation)
 9.61  (0.60)   9.65  (0.66)   9.63  (0.63) 
Corrected Calcium Phosphorus Product (cCa x P) [1] 
[Units: mg²/dL²]
Mean (Standard Deviation)
 55.54  (15.81)   57.37  (15.51)   56.46  (15.67) 
[1] Data were available for 249 and 250 subjects in each treatment group respectively.


  Outcome Measures

1.  Primary:   Percentage of Participants With a > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase   [ Time Frame: Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive). ]

2.  Secondary:   Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase   [ Time Frame: Baseline and the efficacy assessment phase (Week 20 to Week 27) ]

3.  Secondary:   Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase   [ Time Frame: Baseline and the Efficacy Assessment Phase (Week 20 to Week 27) ]

4.  Secondary:   Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase   [ Time Frame: Baseline and the efficacy assessment phase (Week 20 to Week 27) ]

5.  Secondary:   Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product During the Efficacy Assessment Phase   [ Time Frame: Baseline and the efficacy assessment phase (Week 20 to Week 27) ]

6.  Secondary:   Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase   [ Time Frame: Baseline and the efficacy assessment phase (Week 20 to Week 27) ]


  Serious Adverse Events


  Other Adverse Events


  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

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


Publications:

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01785849     History of Changes
Other Study ID Numbers: 20120229
KAI-4169-006 ( Other Identifier: KAI Pharmaceuticals, Inc (wholly owned subsidiary of Amgen Inc.) )
2012-002805-23 ( EudraCT Number )
First Submitted: February 5, 2013
First Posted: February 7, 2013
Results First Submitted: February 7, 2017
Results First Posted: March 27, 2017
Last Update Posted: September 3, 2018