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Completed

NCT Number: NCT01932970

Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide

This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG 416).

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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, Alhambra, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is 18 years of age or older at the time of informed consent.
  • Subject must be receiving maintenance hemodialysis 3 times weekly for at least 8 weeks.
  • Subject must have SHPT as defined by having a mean of 3 consecutive central laboratory screening predialysis serum parathyroid hormone (PTH) values ≥ 200 pg/mL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.
  • Subject must have a mean of 3 consecutive central laboratory screening predialysis serum corrected calcium (cCa) values ≥ 7.5 mg/dL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.
  • Subject must be on a stable dose of cinacalcet before screening (defined as no dose change within the 4 weeks prior to screening).
  • Other Inclusion Criteria may apply.

Exclusion criteria

  • Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).
  • Subject has received AMG 416 in a prior clinical trial of AMG 416 (also known as KAI-4169).
  • Subject has known sensitivity to any of the products or components of AMG 416 to be administered during dosing.
  • Subject is unwilling to use effective contraception during the study, and for women, up to a period of up to 3 months after the last dose of AMG 416.
  • Subject is pregnant or nursing.
  • Anticipated or scheduled parathyroidectomy during the study period.
  • Subject has received a parathyroidectomy within 6 months prior to dosing.
  • Other Exclusion Criteria may apply.

Treatment and study plan

Etelcalcetide

Drug

Etelcalcetide is provided as a sterile lyophilized powder to be reconstituted with sterile water for injection.

Other names: KAI 4169, AMG 416, Parsabiv™

Primary outcomes

  1. Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period

    Time frame: 4 weeks

Secondary outcomes

  1. Percent Change From Baseline in Parathyroid Hormone During the Treatment Period

    Time frame: Baseline and weeks 2, 3 and 4

  2. Percentage of Participants With Serum Corrected Calcium < 8.3 mg/dL During the 4-week Treatment Period

    Time frame: 4 weeks

Other outcomes

  1. Number of Participants With Adverse Events

    Time frame: From the first dose of study drug up to 30 days after the last dose; 8 weeks

  2. Percentage of Participants With Symptomatic Hypocalcemia During the 4-week Treatment Period

    Time frame: From the first dose of study drug up to 30 days after the last dose; 8 weeks

    Hpocalcemia was used for events of decreased calcium accompanied by clinical signs and symptoms of hypocalcemia.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Multicenter, Multiple-dose, Single-arm Study to Switch Hemodialysis Subjects With Secondary Hyperparathyroidism From Oral Cinacalcet HCl to Intravenous AMG 416

Important dates

Study start
2013
Primary completion
2014
Study completion
2017
First posted
Aug 30, 2013
Registry last updated
Oct 17, 2018

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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