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ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism

Primary Purpose

Secondary Hyperparathyroidism

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

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring Vitamin D, Sensipar®, Cinacalcet HCl, Chronic Kidney Disease

Eligibility Criteria

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

Inclusion Criteria: - On hemodialysis for at least 3 months and have received intravenous vitamin D therapy (paricalcitol or doxercalciferol) for at least 3 months prior to entering screening - Historical iPTH 150-800 pg/ml (or biPTH 80-430 pg/ml) within 6 months and corrected serum Ca greater than 8.4 mg/dl within 2 months prior to screening period. For subjects with biPTH 80-160 pg/ml (iPTH 150-300 pg/ml), Ca x P must be greater than 55 mg²/dl² within 2 months prior to the screening period - Screening (pre-washout) biPTH 80-430 pg/ml and a corrected serum Ca level greater than 8.4 mg/dl. For subjects with biPTH 80-160 pg/ml Ca x P must be also greater than 55 mg²/dl² - Baseline mean biPTH (post-washout) greater than 160 pg/ml and mean corrected Ca greater than 8.4 mg/dl Exclusion Criteria: - Parathyroidectomy in the 3 month period prior to screening - 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 a trial of investigational drug or device within 30 days of screening - Females of child bearing potential who are pregnant (e.g., positive pregnancy test) or are breast feeding or who refuse to use highly effective contraceptive measures (as determined by the investigator) throughout the study - Previously participated in this or any other Sensipar® study or has received or is receiving Sensipar® as a commercially available product

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Cinacalcet and low-dose Vitamin D

    Vitamin D alone

    Arm Description

    Cinacalcet and low-dose IV Vitamin D

    Escalating doses of IV Vitamin D alone

    Outcomes

    Primary Outcome Measures

    Achieving the NKF-K/DOQI targets for both biPTH (80-160 pg/mL, equivalent to iPTH 150-300 pg/mL) and Ca x P (less than 55 mg^2/dL^2) during the assessment phase
    Proportion of subjects in each treatment group simultaneously achieving the National Kidney Foundation - Kidney Disease Outcome Quality Initiative (NKF-K/DOQI) targets for both biPTH (80-160 pg/mL, equivalent to iPTH 150-300 pg/mL) and Ca x P (< 55 mg^2/dL^2) during the assessment phase (last 11 weeks of study following a 16-week titration phase)

    Secondary Outcome Measures

    Absolute Change from Baseline for P During the Assessment Phase
    Absolute change from baseline for serum phosphorus (P) during the assessment phase
    Proportion of Participants with ≥ 30% Reduction from Baseline in Mean iPTH During the Assessment Phase
    Proportion of participants with ≥ 30% reduction from baseline in mean intact parathyroid hormone (iPTH) during the assessment phase.
    Percent Change from Baseline for Calcium During the Assessment Phase
    Percent Change from Baseline for Calcium (Ca) During the Assessment Phase
    Percent Change from Baseline for Phosphorus During the Assessment Phase
    Percent change from baseline for Phosphorus (P) during the assessment phase
    Percent Change from Baseline for Ca x P During the Assessment Phase
    Percent change from baseline for calcium x phosphorus (Ca x P) during the assessment phase
    Percent Change from Baseline for iPTH During the Assessment Phase
    Percent change from baseline for intact parathyroid hormone (iPTH) during the assessment phase
    Proportion of Participants who Attained the K/DOQI Target Range for Ca x P During the Assessment Phase.
    Proportion of participants who attained the K/DOQI target range for calcium x phosphorus (Ca x P) during the assessment phase.
    Proportion of Participants who Attained the K/DOQI Target Range for Ca During the Assessment Phase
    Proportion of participants who attained the K/DOQI target range for calcium (Ca) during the assessment phase.
    Proportion of Participants who Attained the K/DOQI Target Range for iPTH During the Assessment Phase
    Proportion of participants who attained the K/DOQI target range for intact parathyroid hormone (iPTH) during the assessment phase.
    Proportion of Participants who Attained the K/DOQI Target Range for P During the Assessment Phase.
    Proportion of participants who attained the K/DOQI target range for phosphorus (P) during the assessment phase.
    Absolute Change from Baseline for iPTH During the Assessment Phase
    Absolute change from baseline for intact parathyroid hormone (iPTH) during the assessment phase.
    Absolute Change from Baseline for Ca During the Assessment Phase
    Absolute change from baseline for calcium (Ca) during the assessment phase
    Absolute Change from Baseline for Ca x P During the Assessment Phase
    Absolute change from baseline for calcium x phosphorus (Ca x P) during the assessment phase.

    Full Information

    First Posted
    August 24, 2005
    Last Updated
    February 7, 2014
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00135304
    Brief Title
    ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism
    Official Title
    ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism: A Comparison of Sensipar® and Low Dose Vitamin D vs. Escalating Doses of Vitamin D Alone
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2005 (undefined)
    Primary Completion Date
    October 2006 (Actual)
    Study Completion Date
    December 2006 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the proportion of chronic kidney disease (CKD) subjects on dialysis receiving Sensipar® and low dose vitamin D or escalating doses of vitamin D alone who are able to achieve the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI) secondary hyperparathyroidism (HPT) treatment targets for both biointact parathyroid hormone (biPTH) and calcium-phosphorus (Ca x P) product.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Secondary Hyperparathyroidism
    Keywords
    Vitamin D, Sensipar®, Cinacalcet HCl, Chronic Kidney Disease

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Cinacalcet and low-dose Vitamin D
    Arm Type
    Experimental
    Arm Description
    Cinacalcet and low-dose IV Vitamin D
    Arm Title
    Vitamin D alone
    Arm Type
    Active Comparator
    Arm Description
    Escalating doses of IV Vitamin D alone
    Intervention Type
    Drug
    Intervention Name(s)
    Sensipar®
    Other Intervention Name(s)
    Cinacalcet hydrochloride, Cinacalcet HCL, Cinacalcet
    Intervention Description
    Cinacalcet hydrochloride
    Intervention Type
    Drug
    Intervention Name(s)
    Vitamin D
    Other Intervention Name(s)
    paricalcitol, doxercalciferol
    Intervention Description
    Vitamin D administered IV
    Primary Outcome Measure Information:
    Title
    Achieving the NKF-K/DOQI targets for both biPTH (80-160 pg/mL, equivalent to iPTH 150-300 pg/mL) and Ca x P (less than 55 mg^2/dL^2) during the assessment phase
    Description
    Proportion of subjects in each treatment group simultaneously achieving the National Kidney Foundation - Kidney Disease Outcome Quality Initiative (NKF-K/DOQI) targets for both biPTH (80-160 pg/mL, equivalent to iPTH 150-300 pg/mL) and Ca x P (< 55 mg^2/dL^2) during the assessment phase (last 11 weeks of study following a 16-week titration phase)
    Time Frame
    Weeks 17 - 27
    Secondary Outcome Measure Information:
    Title
    Absolute Change from Baseline for P During the Assessment Phase
    Description
    Absolute change from baseline for serum phosphorus (P) during the assessment phase
    Time Frame
    Baseline to weeks 17-27
    Title
    Proportion of Participants with ≥ 30% Reduction from Baseline in Mean iPTH During the Assessment Phase
    Description
    Proportion of participants with ≥ 30% reduction from baseline in mean intact parathyroid hormone (iPTH) during the assessment phase.
    Time Frame
    Baseline and Weeks 17-27
    Title
    Percent Change from Baseline for Calcium During the Assessment Phase
    Description
    Percent Change from Baseline for Calcium (Ca) During the Assessment Phase
    Time Frame
    Baseline to weeks 17-27
    Title
    Percent Change from Baseline for Phosphorus During the Assessment Phase
    Description
    Percent change from baseline for Phosphorus (P) during the assessment phase
    Time Frame
    Baseline to weeks 17-27
    Title
    Percent Change from Baseline for Ca x P During the Assessment Phase
    Description
    Percent change from baseline for calcium x phosphorus (Ca x P) during the assessment phase
    Time Frame
    Baseline to weeks 17-27
    Title
    Percent Change from Baseline for iPTH During the Assessment Phase
    Description
    Percent change from baseline for intact parathyroid hormone (iPTH) during the assessment phase
    Time Frame
    Baseline to weeks 17-27
    Title
    Proportion of Participants who Attained the K/DOQI Target Range for Ca x P During the Assessment Phase.
    Description
    Proportion of participants who attained the K/DOQI target range for calcium x phosphorus (Ca x P) during the assessment phase.
    Time Frame
    Weeks 17 - 27
    Title
    Proportion of Participants who Attained the K/DOQI Target Range for Ca During the Assessment Phase
    Description
    Proportion of participants who attained the K/DOQI target range for calcium (Ca) during the assessment phase.
    Time Frame
    Weeks 17-27
    Title
    Proportion of Participants who Attained the K/DOQI Target Range for iPTH During the Assessment Phase
    Description
    Proportion of participants who attained the K/DOQI target range for intact parathyroid hormone (iPTH) during the assessment phase.
    Time Frame
    Weeks 17-27
    Title
    Proportion of Participants who Attained the K/DOQI Target Range for P During the Assessment Phase.
    Description
    Proportion of participants who attained the K/DOQI target range for phosphorus (P) during the assessment phase.
    Time Frame
    Weeks 17-27
    Title
    Absolute Change from Baseline for iPTH During the Assessment Phase
    Description
    Absolute change from baseline for intact parathyroid hormone (iPTH) during the assessment phase.
    Time Frame
    Baseline to weeks 17-27
    Title
    Absolute Change from Baseline for Ca During the Assessment Phase
    Description
    Absolute change from baseline for calcium (Ca) during the assessment phase
    Time Frame
    Baseline to weeks 17-27
    Title
    Absolute Change from Baseline for Ca x P During the Assessment Phase
    Description
    Absolute change from baseline for calcium x phosphorus (Ca x P) during the assessment phase.
    Time Frame
    Baseline to weeks 17-27

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - On hemodialysis for at least 3 months and have received intravenous vitamin D therapy (paricalcitol or doxercalciferol) for at least 3 months prior to entering screening - Historical iPTH 150-800 pg/ml (or biPTH 80-430 pg/ml) within 6 months and corrected serum Ca greater than 8.4 mg/dl within 2 months prior to screening period. For subjects with biPTH 80-160 pg/ml (iPTH 150-300 pg/ml), Ca x P must be greater than 55 mg²/dl² within 2 months prior to the screening period - Screening (pre-washout) biPTH 80-430 pg/ml and a corrected serum Ca level greater than 8.4 mg/dl. For subjects with biPTH 80-160 pg/ml Ca x P must be also greater than 55 mg²/dl² - Baseline mean biPTH (post-washout) greater than 160 pg/ml and mean corrected Ca greater than 8.4 mg/dl Exclusion Criteria: - Parathyroidectomy in the 3 month period prior to screening - 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 a trial of investigational drug or device within 30 days of screening - Females of child bearing potential who are pregnant (e.g., positive pregnancy test) or are breast feeding or who refuse to use highly effective contraceptive measures (as determined by the investigator) throughout the study - Previously participated in this or any other Sensipar® study or has received or is receiving Sensipar® as a commercially available product
    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
    18945995
    Citation
    Fishbane S, Shapiro WB, Corry DB, Vicks SL, Roppolo M, Rappaport K, Ling X, Goodman WG, Turner S, Charytan C. Cinacalcet HCl and concurrent low-dose vitamin D improves treatment of secondary hyperparathyroidism in dialysis patients compared with vitamin D alone: the ACHIEVE study results. Clin J Am Soc Nephrol. 2008 Nov;3(6):1718-25. doi: 10.2215/CJN.01040308.
    Results Reference
    background
    PubMed Identifier
    20951487
    Citation
    Shireman TI, Almehmi A, Wetmore JB, Lu J, Pregenzer M, Quarles LD. Economic analysis of cinacalcet in combination with low-dose vitamin D versus flexible-dose vitamin D in treating secondary hyperparathyroidism in hemodialysis patients. Am J Kidney Dis. 2010 Dec;56(6):1108-16. doi: 10.1053/j.ajkd.2010.07.012. Epub 2010 Oct 15.
    Results Reference
    background
    Citation
    TBD.Sensipar plus low dose vitamin D (ACHIEVE).Journal-004521;
    Results Reference
    background
    Citation
    TBD.Time in target.Journal-004521;
    Results Reference
    background
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism

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