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NCT Number: NCT01785849

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

This study is designed to assess the efficacy and safety of etelcalcetide compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving 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

Loading trial locations.

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 is 18 years of age or older.
  • Subject must be receiving hemodialysis 3 times weekly for at least 3 months
  • 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, or ended treatment on another investigational device or drug study(s) within 8 weeks prior to screening.
  • Other investigational procedures while participating in this study are excluded.
  • Anticipated or scheduled parathyroidectomy during the study period.
  • Subject has received a parathyroidectomy within 3 months prior to dosing.
  • Anticipated or scheduled kidney transplant during the study period.
  • Subject has known sensitivity to any of the products or components to be administered during dosing.
  • Subject has participated in a prior clinical trial of AMG 416 (also referred to as KAI-4169).
  • Subject has received cinacalcet within the 4 weeks prior to screening labs (treatment with cinacalcet is prohibited during the study).
  • 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 intravenously three times per week. The starting dose was 5 mg. The dose may have been increased at 4-week intervals by 2.5 mg or 5 mg on the basis of the predialysis parathyroid hormone and corrected calcium concentrations obtained in the prior week. The minimum dose was 2.5 mg and the maximum dose was 15 mg.

Other names: AMG 416, KAI-4169

Placebo

Drug

Administered intravenously (IV) three times per week.

Primary outcomes

  1. 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).

    Participants who did not have any scheduled assessments during the EAP were considered non-responders.

Secondary outcomes

  1. 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)

    Participants who had no scheduled assessments during the EAP were considered non-responders.

  2. 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)

  3. 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)

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the 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
2014
Study completion
2014
First posted
Feb 7, 2013
Registry last updated
Aug 26, 2019

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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