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START: Sensipar Treatment Algorithm to Reach K/DOQI Targets in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism

Primary Purpose

Kidney Disease, Secondary Hyperparathyroidism, Chronic Kidney Disease

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sensipar
Sponsored by
Amgen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Kidney Disease focused on measuring calcimimetic, cinacalcet, hemodialysis, secondary hyperparathyroidism, chronic kidney disease

Eligibility Criteria

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

Inclusion Criteria: - Subjects with chronic kidney disease who have received dialysis for at least one month before the first dose of study medication and are clinically stable. - Adults at least 18 years of age who have given written informed consent. - Out of target PTH values, defined as the most recent historical measurement of biPTH > 160 pg/mL within 3 months prior to informed consent signature. - Serum calcium >/= 8.4 mg/dL within one month prior to informed consent signature. Exclusion Criteria: - Unstable medical condition, defined as having been hospitalized within 30 days before Day 1, or otherwise unstable in the judgement of the investigator. Hospitalization solely for dialysis vascular access revision does not qualify as an unstable medical condition. - Parathyroidectomy in the 3 months before Day 1. - Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets. - Use of investigational drug or device or participation in trial of investigational drug or device (except experimental dialysis machines) within 30 days of enrollment into the study. Any investigational procedures. - Females of child-bearing potential who are pregnant (e.g., positive serum pregnancy test) or are breast feeding. Females of child bearing potential who refuse to use highly effective contraceptive measures (as determined by the investigator) throughout the study. - Hypersensitivity to Sensipar or any of its components. - Previously participated in this or any other Sensipar study, or received/is receiving Sensipar as a commercially available product. - Disorder that would compromise the ability of the subject to give written informed consent and/or to comply with study procedures.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Proportion of subjects with a mean bio-intact parathyroid hormone (biPTH) >/= 80 pg/mL and </= 160 pg/mL (comparable to K/DOQI Guideline target range for intact parathyroid hormone [iPTH] of >/= 150 pg/mL and </= 300 pg/mL) during the assessment phase

    Secondary Outcome Measures

    Proportion of subjects with mean calcium-phosphorus product (Ca x P) < 55 mg²/dL² during the assessment phase

    Full Information

    First Posted
    August 19, 2005
    Last Updated
    February 12, 2009
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00132431
    Brief Title
    START: Sensipar Treatment Algorithm to Reach K/DOQI Targets in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism
    Official Title
    Sensipar Treatment Algorithm to Reach K/DOQI Targets in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this research is to study the effects and safety of Sensipar approved by the Food and Drug Administration (FDA) in patients with kidney failure who are being treated with dialysis and have uncontrolled secondary hyperparathyroidism (HPT).
    Detailed Description
    The purposes of this study are: - To assess the effectiveness of a treatment algorithm that includes Sensipar on bio-intact parathyroid hormone (biPTH), adjusted serum calcium (Ca), serum phosphorus (P), and calcium-phosphorus product (Ca x P) levels in the management of SHPT in CKD subjects on dialysis by determining achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) Guideline targets. - To assess the use of vitamin D sterols and phosphate binders when Sensipar is incorporated in the treatment of SHPT. - To assess the safety and tolerability of Sensipar.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Disease, Secondary Hyperparathyroidism, Chronic Kidney Disease
    Keywords
    calcimimetic, cinacalcet, hemodialysis, secondary hyperparathyroidism, chronic kidney disease

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    300 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Sensipar
    Primary Outcome Measure Information:
    Title
    Proportion of subjects with a mean bio-intact parathyroid hormone (biPTH) >/= 80 pg/mL and </= 160 pg/mL (comparable to K/DOQI Guideline target range for intact parathyroid hormone [iPTH] of >/= 150 pg/mL and </= 300 pg/mL) during the assessment phase
    Secondary Outcome Measure Information:
    Title
    Proportion of subjects with mean calcium-phosphorus product (Ca x P) < 55 mg²/dL² during the assessment phase

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Subjects with chronic kidney disease who have received dialysis for at least one month before the first dose of study medication and are clinically stable. - Adults at least 18 years of age who have given written informed consent. - Out of target PTH values, defined as the most recent historical measurement of biPTH > 160 pg/mL within 3 months prior to informed consent signature. - Serum calcium >/= 8.4 mg/dL within one month prior to informed consent signature. Exclusion Criteria: - Unstable medical condition, defined as having been hospitalized within 30 days before Day 1, or otherwise unstable in the judgement of the investigator. Hospitalization solely for dialysis vascular access revision does not qualify as an unstable medical condition. - Parathyroidectomy in the 3 months before Day 1. - Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets. - Use of investigational drug or device or participation in trial of investigational drug or device (except experimental dialysis machines) within 30 days of enrollment into the study. Any investigational procedures. - Females of child-bearing potential who are pregnant (e.g., positive serum pregnancy test) or are breast feeding. Females of child bearing potential who refuse to use highly effective contraceptive measures (as determined by the investigator) throughout the study. - Hypersensitivity to Sensipar or any of its components. - Previously participated in this or any other Sensipar study, or received/is receiving Sensipar as a commercially available product. - Disorder that would compromise the ability of the subject to give written informed consent and/or to comply with study procedures.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
    Description
    Notice regarding posted summaries of trial results
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_38_AMG_073_20040123.pdf
    Description
    To access clinical trial results information click on this link
    URL
    http://www.sensipar.com/
    Description
    FDA-approved Drug Labeling
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    START: Sensipar Treatment Algorithm to Reach K/DOQI Targets in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism

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