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Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder

Primary Purpose

Secondary Hyperparathyroidism

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Etelcalcetide
Sponsored by
KAI Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring Clinical Trial, Phase 2, Renal Dialysis, Secondary Hyperparathyroidism, Chronic kidney disease-mineral and bone disorder, Parathyroid hormone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects provides written informed consent
  • Screening intact PTH (iPTH) ≥ 350 pg/mL and corrected calcium ≥ 8.5 mg/dL
  • Hemoglobin ≥ 8.5 g/dL
  • Serum transaminases (alanine transaminase [ALT], aspartate transaminase [AST]) less than 2.5 times the upper limit of normal
  • Adequate hemodialysis three times per week

Exclusion Criteria:

  • History or symptomatic ventricular dysrhythmias
  • History of angina pectoris or congestive heart failure
  • History of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months
  • History of or treatment for seizure disorder within the last 12 months
  • Postdialysis systolic blood pressure > 180 mmHg or diastolic blood pressure > 90 mmHg
  • Serum magnesium below the lower limit of normal at screening

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Etelcalcetide

    Arm Description

    Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.

    Outcomes

    Primary Outcome Measures

    Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Period
    Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.

    Secondary Outcome Measures

    Percentage of Participants With ≥ 30% Reduction in PTH From Baseline During the Efficacy Period
    The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
    Percentage of Participants With PTH ≤ 300 pg/mL During the Efficacy Period
    The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
    Percent Change From Baseline in Corrected Calcium During the Efficacy Period
    Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
    Percent Change From Baseline in Phosphorus During the Efficacy Period
    Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.

    Full Information

    First Posted
    August 9, 2011
    Last Updated
    February 27, 2017
    Sponsor
    KAI Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01414114
    Brief Title
    Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder
    Official Title
    A Single-arm, Open-label, Multicenter, Dose Titration Study of KAI-4169 to Treat Secondary Hyperparathyroidism in Hemodialysis Subjects With Chronic Kidney Disease-Mineral and Bone Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 5, 2011 (undefined)
    Primary Completion Date
    May 21, 2012 (Actual)
    Study Completion Date
    May 21, 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    KAI Pharmaceuticals

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients with chronic kidney disease-mineral and bone disorder (CKD-MBD).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Secondary Hyperparathyroidism
    Keywords
    Clinical Trial, Phase 2, Renal Dialysis, Secondary Hyperparathyroidism, Chronic kidney disease-mineral and bone disorder, Parathyroid hormone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    37 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Etelcalcetide
    Arm Type
    Experimental
    Arm Description
    Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
    Intervention Type
    Drug
    Intervention Name(s)
    Etelcalcetide
    Other Intervention Name(s)
    KAI-4169, AMG 416, Parsabiv™
    Intervention Description
    Administered 3 times a week by bolus injection into the venous line of the dialysis circuit after the end of hemodialysis.
    Primary Outcome Measure Information:
    Title
    Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Period
    Description
    Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
    Time Frame
    Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With ≥ 30% Reduction in PTH From Baseline During the Efficacy Period
    Description
    The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
    Time Frame
    Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)
    Title
    Percentage of Participants With PTH ≤ 300 pg/mL During the Efficacy Period
    Description
    The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
    Time Frame
    The efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)
    Title
    Percent Change From Baseline in Corrected Calcium During the Efficacy Period
    Description
    Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
    Time Frame
    Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)
    Title
    Percent Change From Baseline in Phosphorus During the Efficacy Period
    Description
    Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
    Time Frame
    Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects provides written informed consent Screening intact PTH (iPTH) ≥ 350 pg/mL and corrected calcium ≥ 8.5 mg/dL Hemoglobin ≥ 8.5 g/dL Serum transaminases (alanine transaminase [ALT], aspartate transaminase [AST]) less than 2.5 times the upper limit of normal Adequate hemodialysis three times per week Exclusion Criteria: History or symptomatic ventricular dysrhythmias History of angina pectoris or congestive heart failure History of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months History of or treatment for seizure disorder within the last 12 months Postdialysis systolic blood pressure > 180 mmHg or diastolic blood pressure > 90 mmHg Serum magnesium below the lower limit of normal at screening
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gregory Bell, MD
    Organizational Affiliation
    KAI Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder

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