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20070360 Incident Dialysis

Primary Purpose

Chronic Kidney Disease, Secondary Hyperparathyroidism

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cinacalcet
Vitamin D
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Adults greater than or equal to 18 years of age on hemodialysis for > 3 and less than or equal to 12 months prior to enrollment into the study
  • Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) > 300 pg/mL (31.8 pmol/L); or biPTH > 160 pg/mL (17.0 pmol/L)
  • Mean of 2 corrected serum calcium determinations drawn on the same day as the PTH determinations greater than or equal to 8.4 mg/dL (2.1 mmol/L)
  • Subject will be able to complete the study, to the best of his/her knowledge
  • Before any study-specific procedure, the appropriate written informed consent must be obtained

Exclusion Criteria:

  • Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) > 800 pg/mL (84.9 pmol/L); or biPTH > 430 pg/mL (45.6 pmol/L) AND receiving vitamin D on entering screening
  • Parathyroidectomy (partial or full) less than or equal to 6 months before entering screening
  • Anticipated parathyroidectomy (partial or full) within 6 months after randomization
  • Have a scheduled date for kidney transplant surgery
  • Received cinacalcet since initiating hemodialysis
  • Have received vitamin D therapy for less than 30 days before entering screening or required a change in prescribed vitamin D brand or dose within 30 days before entering screening. If subjects are not receiving vitamin D therapy, they must remain free of vitamin D therapy for the 30 days before entering screening
  • Subject is pregnant (eg, positive HCG test) or is breast-feeding
  • Refusal to use highly effective contraceptive measures (as determined by the investigator) throughout the study (screening and post enrollment)
  • Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets
  • Known sensitivity, intolerance, or other adverse response to cinacalcet which would prevent on-study treatment compliance
  • Have an unstable medical condition within 30 days before screening, or otherwise unstable in the judgment of the investigator
  • Subject is currently enrolled in, or fewer than 30 days prior to entering screening have passed since subject received other investigational agent(s) (devices or drug).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Cinacalcet Group

    Control Group

    Arm Description

    Cinacalcet plus low dose active Vitamin D (if prescribed)

    Flexible active vitamin D dosing

    Outcomes

    Primary Outcome Measures

    Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
    All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For participants with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

    Secondary Outcome Measures

    Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
    All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
    All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
    All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
    All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
    All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
    All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
    All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Achievement of a >= 30% Reduction in Mean iPTH From Baseline to During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Achievement of a Mean iPTH <=300 pg/mL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Summary of iPTH (pg/mL) at Month 6 Efficacy Assessment Phase
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 6 Efficacy Assessment Phase
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Summary of iPTH (pg/mL) at Month 12 Efficacy Assessment Phase
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 12 Efficacy Assessment Phase
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Summary of Corrected Serum Calcium (mg/dL) at Month 6 Efficacy Assessment Phase
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 6 Efficacy Assessment Phase
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Summary of Corrected Serum Calcium (mg/dL) at Month 12 Efficacy Assessment Phase
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 12 Efficacy Assessment Phase
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Summary of Serum Phosphorus (mg/dL) at Month 6 Efficacy Assessment Phase
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Summary of Percent Change From Baseline in Serum Phosphorus at Month 6 Efficacy Assessment Phase
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Summary of Serum Phosphorus (mg/dL) at Month 12 Efficacy Assessment Phase
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Summary of Percent Change From Baseline in Serum Phosphorus at Month 12 Efficacy Assessment Phase
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 6
    Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL
    Subject Incidence of Hypercalcemia During the Maintenance Phase
    Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL
    Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 12
    Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL
    Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 6
    Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL
    Subject Incidence of Hyperphosphatemia During the Maintenance Phase
    Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL
    Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 12
    Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL

    Full Information

    First Posted
    November 26, 2008
    Last Updated
    September 20, 2018
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00803712
    Brief Title
    20070360 Incident Dialysis
    Official Title
    Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination With Low Dose Vitamin D for the Treatment of Subjects With Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2009 (Actual)
    Primary Completion Date
    December 9, 2010 (Actual)
    Study Completion Date
    July 5, 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Disease, Secondary Hyperparathyroidism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    313 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cinacalcet Group
    Arm Type
    Experimental
    Arm Description
    Cinacalcet plus low dose active Vitamin D (if prescribed)
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    Flexible active vitamin D dosing
    Intervention Type
    Drug
    Intervention Name(s)
    Cinacalcet
    Other Intervention Name(s)
    Sensipar/Mimpara
    Intervention Description
    Cinacalcet is a calcimimetic agent, which is synthesized as a hydrochloride salt.
    Intervention Type
    Drug
    Intervention Name(s)
    Vitamin D
    Other Intervention Name(s)
    Active Vitamin D
    Intervention Description
    Titration of active Vitamin D in accordance with treatment practice guidelines in order to treat Secondary Hyperparathyroidism.
    Primary Outcome Measure Information:
    Title
    Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
    Description
    All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For participants with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 22-26
    Secondary Outcome Measure Information:
    Title
    Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
    Description
    All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 22-26
    Title
    Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
    Description
    All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 48-52
    Title
    Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
    Description
    All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 48-52
    Title
    Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
    Description
    All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 22-26
    Title
    Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
    Description
    All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 48-52
    Title
    Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
    Description
    All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 22-26
    Title
    Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
    Description
    All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 48-52
    Title
    Achievement of a >= 30% Reduction in Mean iPTH From Baseline to During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
    Description
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 22-26 and Weeks 48-52
    Title
    Achievement of a Mean iPTH <=300 pg/mL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
    Description
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 22-26 and Weeks 48-52
    Title
    Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
    Description
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 22-26 and Weeks 48-52
    Title
    Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
    Description
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 22-26 and Weeks 48-52
    Title
    Summary of iPTH (pg/mL) at Month 6 Efficacy Assessment Phase
    Description
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 22-26
    Title
    Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 6 Efficacy Assessment Phase
    Description
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 22-26
    Title
    Summary of iPTH (pg/mL) at Month 12 Efficacy Assessment Phase
    Description
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 48-52
    Title
    Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 12 Efficacy Assessment Phase
    Description
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 48-52
    Title
    Summary of Corrected Serum Calcium (mg/dL) at Month 6 Efficacy Assessment Phase
    Description
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 22-26
    Title
    Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 6 Efficacy Assessment Phase
    Description
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 22-26
    Title
    Summary of Corrected Serum Calcium (mg/dL) at Month 12 Efficacy Assessment Phase
    Description
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 48-52
    Title
    Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 12 Efficacy Assessment Phase
    Description
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 48-52
    Title
    Summary of Serum Phosphorus (mg/dL) at Month 6 Efficacy Assessment Phase
    Description
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 22-26
    Title
    Summary of Percent Change From Baseline in Serum Phosphorus at Month 6 Efficacy Assessment Phase
    Description
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 22-26
    Title
    Summary of Serum Phosphorus (mg/dL) at Month 12 Efficacy Assessment Phase
    Description
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 48-52
    Title
    Summary of Percent Change From Baseline in Serum Phosphorus at Month 12 Efficacy Assessment Phase
    Description
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.
    Time Frame
    Weeks 48-52
    Title
    Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 6
    Description
    Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL
    Time Frame
    Weeks 22-26
    Title
    Subject Incidence of Hypercalcemia During the Maintenance Phase
    Description
    Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL
    Time Frame
    Weeks 26-48
    Title
    Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 12
    Description
    Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL
    Time Frame
    Weeks 48-52
    Title
    Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 6
    Description
    Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL
    Time Frame
    Weeks 22-26
    Title
    Subject Incidence of Hyperphosphatemia During the Maintenance Phase
    Description
    Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL
    Time Frame
    Weeks 26-48
    Title
    Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 12
    Description
    Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL
    Time Frame
    Weeks 48-52

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults greater than or equal to 18 years of age on hemodialysis for > 3 and less than or equal to 12 months prior to enrollment into the study Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) > 300 pg/mL (31.8 pmol/L); or biPTH > 160 pg/mL (17.0 pmol/L) Mean of 2 corrected serum calcium determinations drawn on the same day as the PTH determinations greater than or equal to 8.4 mg/dL (2.1 mmol/L) Subject will be able to complete the study, to the best of his/her knowledge Before any study-specific procedure, the appropriate written informed consent must be obtained Exclusion Criteria: Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) > 800 pg/mL (84.9 pmol/L); or biPTH > 430 pg/mL (45.6 pmol/L) AND receiving vitamin D on entering screening Parathyroidectomy (partial or full) less than or equal to 6 months before entering screening Anticipated parathyroidectomy (partial or full) within 6 months after randomization Have a scheduled date for kidney transplant surgery Received cinacalcet since initiating hemodialysis Have received vitamin D therapy for less than 30 days before entering screening or required a change in prescribed vitamin D brand or dose within 30 days before entering screening. If subjects are not receiving vitamin D therapy, they must remain free of vitamin D therapy for the 30 days before entering screening Subject is pregnant (eg, positive HCG test) or is breast-feeding Refusal to use highly effective contraceptive measures (as determined by the investigator) throughout the study (screening and post enrollment) Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets Known sensitivity, intolerance, or other adverse response to cinacalcet which would prevent on-study treatment compliance Have an unstable medical condition within 30 days before screening, or otherwise unstable in the judgment of the investigator Subject is currently enrolled in, or fewer than 30 days prior to entering screening have passed since subject received other investigational agent(s) (devices or drug).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23365129
    Citation
    Rodriguez M, Urena-Torres P, Petavy F, Cooper K, Farouk M, Goodman WG. Calcium-mediated parathyroid hormone suppression to assess progression of secondary hyperparathyroidism during treatment among incident dialysis patients. J Clin Endocrinol Metab. 2013 Feb;98(2):618-25. doi: 10.1210/jc.2012-3246. Epub 2013 Jan 30.
    Results Reference
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    PubMed Identifier
    23328710
    Citation
    Urena-Torres P, Bridges I, Christiano C, Cournoyer SH, Cooper K, Farouk M, Kopyt NP, Rodriguez M, Zehnder D, Covic A. Efficacy of cinacalcet with low-dose vitamin D in incident haemodialysis subjects with secondary hyperparathyroidism. Nephrol Dial Transplant. 2013 May;28(5):1241-54. doi: 10.1093/ndt/gfs568. Epub 2013 Jan 16.
    Results Reference
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    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

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    20070360 Incident Dialysis

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