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Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

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ClinicalTrials.gov Identifier: NCT01785875
Recruitment Status : Completed
First Posted : February 7, 2013
Results First Posted : March 27, 2017
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE February 5, 2013
First Posted Date  ICMJE February 7, 2013
Results First Submitted Date  ICMJE February 7, 2017
Results First Posted Date  ICMJE March 27, 2017
Last Update Posted Date April 10, 2019
Actual Study Start Date  ICMJE July 31, 2013
Actual Primary Completion Date July 1, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2017)
  • Number of Participants With Adverse Events (AEs) [ Time Frame: From first dose until 30 days after last dose; the treatment period was 52 weeks. ]
    Treatment-related adverse events are those the investigator indicated as having a reasonable possibility of having been caused by etelcalcetide. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event.
  • Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4 [ Time Frame: 52 weeks ]
    Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 0 represents values in the normal range and grade 4 represents values with life-threatening consequences and urgent intervention indicated.
  • Number of Participants Who Developed Anti-etelcalcetide Antibodies [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit ]
    A validated dual flow-cell biosensor immunoassay was used to detect antibodies capable of binding etelcalcetide. The number of participants with a negative or no result at baseline and positive binding antibodies at any time post-baseline is reported.
  • Change From Baseline in Blood Pressure [ Time Frame: Baseline and Weeks 24 and 48 ]
    Blood pressure (BP) values were taken post-hemodialysis assessments.
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2013)
Number of subjects with adverse events [ Time Frame: One year ]
Change History Complete list of historical versions of study NCT01785875 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2017)
  • Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase [ Time Frame: Baseline and the efficacy assessment phase, defined as the last 6 weeks prior to ending treatment for participants who completed a minimum of 8 weeks of treatment (weeks 46-52 for participants who completed 52 weeks of treatment) ]
    The efficacy assessment phase (EAP) is defined as the last 6 weeks before ending treatment, which was only for participants who completed a minimum of 8 weeks of treatment with etelcalcetide. If multiple assessments were available during the EAP, values were averaged.
  • Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12 [ Time Frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53) ]
    The efficacy assessment phase at 12 months (EAP12) was defined as the period from week 46 to 53 (inclusive). If multiple assessments were available during the EAP12, values were averaged.
  • Percentage of Participants With PTH ≤ 300 pg/mL During the EAP [ Time Frame: Baseline and the efficacy assessment phase ]
  • Percentage of Participants With PTH ≤ 300 pg/mL During the EAP12 [ Time Frame: Week 46 to 53 ]
  • Percent Change From Baseline in Mean PTH During the EAP [ Time Frame: Baseline and the efficacy assessment phase ]
  • Percent Change From Baseline in Mean PTH During the EAP12 [ Time Frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53) ]
  • Percent Change From Baseline in Mean Corrected Calcium During the EAP [ Time Frame: Baseline and the efficacy assessment phase ]
  • Percent Change From Baseline in Mean Corrected Calcium During the EAP12 [ Time Frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53) ]
  • Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP [ Time Frame: Baseline and the efficacy assessment phase ]
  • Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP12 [ Time Frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53) ]
  • Percent Change From Baseline in Mean Phosphorus During the EAP [ Time Frame: Baseline and the efficacy assessment phase ]
  • Percent Change From Baseline in Mean Phosphorus During the EAP12 [ Time Frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2013)
  • Proportion of subjects with >30% reduction from baseline in predialysis iPTH during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12) [ Time Frame: One year ]
  • Proportion of subjects with predialysis iPTH ≤ 300 pg/mL during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12) [ Time Frame: One year ]
  • Percent change from baseline in predialysis iPTH during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12) [ Time Frame: One year ]
  • Percent change from baseline in predialysis serum cCa during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12) [ Time Frame: One year ]
  • Percent change from baseline in predialysis serum cCa x P during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12) [ Time Frame: One year ]
  • Percent change from baseline in predialysis serum phosphorus during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12) [ Time Frame: One year ]
  • Percentage of subjects whose cCa fall into each of the following categories (<8.3 - 7.5 mg/dL; <7.5 - 7.0 mg/dL; <7.0 mg/dL) [ Time Frame: One year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
Official Title  ICMJE A Multicenter Single-arm Extension Study to Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis
Brief Summary This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hyperparathyroidism, Secondary
Intervention  ICMJE Drug: Etelcalcetide
Administered by bolus injection into the venous line of the dialysis circuit at the end of hemodialysis treatment, and prior to or during rinse-back with each hemodialysis session (ie, 3 times per week).
Other Name: AMG 416
Study Arms  ICMJE Experimental: Etelcalcetide
Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Intervention: Drug: Etelcalcetide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2014)
891
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2013)
1000
Actual Study Completion Date  ICMJE July 1, 2015
Actual Primary Completion Date July 1, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
  • Subject must complete the treatment and follow-up period, or have been discontinued for rising intact parathyroid hormone (iPTH), from an AMG 416 phase 3 parent study prior to the start of dosing in this study: 20120229 (NCT01785849), 20120230 (NCT01788046), or 20120359 (NCT01932970).
  • Subject agrees to not participate in another study of an investigational agent during the study.
  • Other Inclusion Criteria may apply

Exclusion Criteria:

  • Currently receiving treatment in another investigational device or drug study.
  • Currently receiving other investigational procedures while participating in this study.
  • Subject has known sensitivity to any of the products or components to be administered during dosing.
  • Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator.

Other Exclusion Criteria may apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   Czechia,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   Poland,   Russian Federation,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01785875
Other Study ID Numbers  ICMJE 20120231
KAI-4169-008 ( Other Identifier: KAI Pharmaceuticals, Inc (wholly owned subsidiary of Amgen Inc.) )
2012-002808-41 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP