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Completed

NCT Number: NCT01896232

Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet

The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.

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Key information

Conditions

Secondary Hyperparathyroidism Chronic Disease Chronic Kidney Disease Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Male Urogenital Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Feldkirch, Austria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Eligible subjects must be receiving adequate thrice weekly maintenance hemodialysis with a dialysate calcium concentration ≥ 2.5 mEq/L for at least 3 months prior to screening laboratory assessments
  • Subjects must have SHPT as defined by one central laboratory screening predialysis serum PTH value > 500 pg/mL, measured on separate days within 2 weeks prior to randomization
  • Subjects must have one serum cCa value ≥ 8.3 mg/dL obtained before dialysis within 2 weeks of the date of randomization
  • Subjects receiving calcium supplements must have no more than a maximum dose change of 50% within 2 weeks before screening laboratory assessments are obtained, and the dose must remain unchanged through randomization

Exclusion criteria

  • Eligible subjects cannot have received cinacalcet during the 3 months preceding the first screening laboratory assessment
  • Other criteria may apply

Treatment and study plan

Etelcalcetide

Drug

Administered intravenously three times per week. The starting dose was 5 mg, titrated up to 15 mg based on serum PTH and corrected calcium levels.

Other names: AMG 416

Cinacalcet

Drug

Cinacalcet was administered orally once a day. The starting dose was 30 mg daily, titrated up to 180 mg daily based on serum PTH and corrected calcium levels.

Other names: Sensipar®, Mimpara®

oral placebo

Drug

Administered orally once a day.

Intravenous placebo

Drug

Administered intravenously (IV) three times per week.

Primary outcomes

  1. Percentage of Participants With > 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis

    Time frame: Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).

Secondary outcomes

  1. Percentage of Participants With > 50% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase

    Time frame: Baseline and the efficacy assessment phase (Weeks 20 to 27, inclusive).

  2. Percentage of Participants With > 30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase

    Time frame: Baseline and the efficacy assessment phase (Week 20 to Week 27)

  3. Mean Number of Days of Vomiting or Nausea Per Week in the First 8 Weeks

    Time frame: First 8 weeks

    Participants completed the Nausea/Vomiting Symptom Assessment (NVSA) questionnaire daily. This questionnaire asked participants to indicate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined) and if they had vomited in the past 24 hours. A day of vomiting or nausea was defined as those where the severity of nausea score was > 0 or where the episodes of vomiting score was > 0.

  4. Percent Change From Baseline in Mean Corrected Calcium During the Efficacy Assessment Phase

    Time frame: Baseline and the efficacy assessment phase (weeks 20 - 27)

  5. Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase

    Time frame: Efficacy assessment phase (weeks 20 - 27)

  6. Mean Severity of Nausea in the First 8 Weeks

    Time frame: First 8 weeks

    Severity of nausea was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asked participants to rate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined). For each participant, the mean severity of nausea was calculated by averaging all available daily severities (including zeroes) reported in the first 8 weeks.

  7. Mean Number of Episodes of Vomiting Per Week in the First 8 Weeks

    Time frame: First 8 weeks

    The number of vomiting episodes was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asks participants on a daily basis how many times they vomited in the past 24 hours. The number of episodes in a week is the sum of all reported daily episodes in the week.

    For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Multicenter, Multiple-dose, Two-arm, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet HCl With Intravenous Doses of AMG 416 in Hemodialysis Subjects With Secondary Hyperparathyroidism

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jul 11, 2013
Registry last updated
Jul 18, 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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