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Completed

NCT Number: NCT01785875

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

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.

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Key information

Conditions

Hyperparathyroidism, Secondary Calcium Metabolism Disorders Chronic Disease Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Hypocalcemia Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Water-Electrolyte Imbalance

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Liverpool, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Etelcalcetide

Drug

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 names: AMG 416

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Change From Baseline in Blood Pressure

    Time frame: Baseline and Weeks 24 and 48

    Blood pressure (BP) values were taken post-hemodialysis assessments.

Secondary outcomes

  1. 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.

  2. 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.

  3. Percentage of Participants With PTH ≤ 300 pg/mL During the EAP

    Time frame: Baseline and the efficacy assessment phase

  4. Percentage of Participants With PTH ≤ 300 pg/mL During the EAP12

    Time frame: Week 46 to 53

  5. Percent Change From Baseline in Mean PTH During the EAP

    Time frame: Baseline and the efficacy assessment phase

  6. Percent Change From Baseline in Mean PTH During the EAP12

    Time frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)

  7. Percent Change From Baseline in Mean Corrected Calcium During the EAP

    Time frame: Baseline and the efficacy assessment phase

  8. 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)

  9. Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP

    Time frame: Baseline and the efficacy assessment phase

  10. 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)

  11. Percent Change From Baseline in Mean Phosphorus During the EAP

    Time frame: Baseline and the efficacy assessment phase

  12. Percent Change From Baseline in Mean Phosphorus During the EAP12

    Time frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 7, 2013
Registry last updated
Apr 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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