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    Summary
    EudraCT Number:2012-002806-31
    Sponsor's Protocol Code Number:20120230(KAI-4169-007)
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-23
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2012-002806-31
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of AMG 416 in the treatment of secondary hyperparathyroidism in chronic kidney disease
    A.4.1Sponsor's protocol code number20120230(KAI-4169-007)
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKAI Pharmaceuticals, Inc. (a subsidiary of Amgen, Inc.)
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKAI Pharmaceuticals, Inc. (a subsidiary of Amgen, Inc.)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen Limited
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address240 Cambridge Science Park, Milton Road
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB4 0WD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441223436 165
    B.5.5Fax number0011223426 814
    B.5.6E-mailgardnerj@amgen.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAMG 416 (KAI-4169)
    D.3.2Product code AMG 416 (KAI-4169)
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMG 416
    D.3.9.1CAS number 1334237-71-6
    D.3.9.2Current sponsor codeAMG 416
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboLyophilisate for solution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Secondary hyperparathyroidism in subjects with chronic kidney disease
    E.1.1.1Medical condition in easily understood language
    Hyperparathyroidism (high levels of parathyroid hormone) secondary to chronic kidney disease
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10020708
    E.1.2Term Hyperparathyroidism secondary
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10020706
    E.1.2Term Hyperparathyroidism NOS
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of AMG 416 compared with placebo for reducing the serum intact parathyroid hormone level (iPTH) by > 30%
    E.2.2Secondary objectives of the trial
    To evaluate the impact of AMG 416 compared with placebo on
    corrected calcium (cCa), corrected calcium-phosphorus product (cCa x P), and phosphorus

    Safety objectives
    • to assess the safety and tolerability of AMG 416 compared with placebo

    Exploratory objectives
    • to evaluate the pharmacokinetics (PK) of AMG 416
    • to characterize the effect of multiple doses of AMG 416 on FGF-23 levels
    • to characterize the effect of multiple doses of AMG 416 on bone specific alkaline phosphatase levels (BSAP)
    • to characterize the effect of multiple doses of AMG 416 on tartrate resistant acid phosphatase-5b (TRAP5b) levels
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
    • Subject is 18 years of age or older.
    • Female subjects who are post menopausal (post menopausal is defined as no menses for the previous 1 year and over the age of 50 years), surgically sterilized, have a medical condition that prevents pregnancy, remain abstinent, or are willing to use highly effective contraception during the study and for 3 months after the last dose. Women of child-bearing potential must have a negative serum pregnancy test within 2 weeks prior to the first dose of investigational product.
    • Subject receiving active vitamin D sterols must have had no more than a maximum dose change of 50% within the 4 weeks prior to screening laboratory assessments, remain stable through randomization, and be expected to maintain stable doses for the duration of the study, except for
    adjustments allowed per protocol.
    • Subject receiving phosphate binders must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through randomization, and be expected to maintain stable dose for the duration of the study, except for
    adjustments allowed per protocol.
    • Subject receiving calcium supplements must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments and remain stable through randomization.
    • Subject must be receiving hemodialysis 3 times weekly for at least 3 months and have adequate hemodialysis with a delivered Kt/V ≥ 1.2 or urea reduction ratio (URR) ≥ 65% within 4 weeks prior to screening laboratory assessments.
    • Dialysis prescription dialysate calcium concentration must be ≥ 2.25 mEq/L and stable for at least 4 weeks prior to screening laboratory assessments, remain stable through randomization and remain ≥ 2.25 mEq/L for the duration of the study.
    • Subject must have 2 consecutive screening predialysis serum iPTH labs drawn on separate days within 2 weeks prior to randomization and the results of both must be > 400 pg/mL. Enrollment of subjects with mean screening iPTH > 1000 pg/mL will be limited to approximately 20% of subjects.
    • Subject must have 2 consecutive screening predialysis serum cCa labs drawn on separate days within 2 weeks prior to randomization and the results of both must be ≥ 8.3 mg/dL.
    • Subject agrees to not participate in another study of an investigational agent during the study.
    • Subject’s legally acceptable representative has provided informed consent when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
    E.4Principal exclusion criteria
    • Currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(s) within 8 weeks prior to screening.
    • Other investigational procedures while participating in this study are excluded.
    • Anticipated or scheduled parathyroidectomy during the study period.
    • Subject has received a parathyroidectomy within 3 months prior to dosing.
    • Anticipated or scheduled kidney transplant during the study period.
    • Subject has known sensitivity to any of the products or components to be administered during dosing.
    • Subject has previously been randomized in this study.
    • Subject has received AMG 416 in a prior clinical trial of AMG 416 (also referred to as KAI-4169).
    • Subject has received cinacalcet within the 4 weeks prior to screening labs (treatment with cinacalcet is prohibited during the study).
    • Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator.
    • Subject has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject.
    • Subject history of malignancy within the last 5 years (except non-melanoma skin cancers, or cervical carcinoma in situ).
    • Subject has a serious concurrent medical condition (eg, malignancy) likely to result in death during the next 12 months.
    • Subject is pregnant or nursing.
    • Subject has a history of symptomatic ventricular dysrhythmias or Torsades de Pointes.
    • Subject’s screening 12-lead electrocardiogram (ECG) suggests unstable arrhythmia or other cardiac abnormality that could place the subject at increased risk, based upon the Investigator’s opinion.
    • Subject has a history of poorly controlled hypertension.
    • Subject has a history within the past 6 months of either angina pectoris with symptoms that occur at rest or minimal activity or a history of congestive heart failure (New York Heart Association Classification III or IV).
    • Subject has a history of myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months prior to screening.
    • Subject is receiving treatment for a seizure disorder or has a history of a seizure within the last 12 months prior to screening.
    • Subject has had surgery (except minor surgery) within the last 8 weeks prior to screening.
    • Subject has clinically significant abnormalities on prestudy clinical
    examination or abnormalities on the most recent central laboratory tests during the screening period prior to randomization according to the Investigator including but not limited to the following:
    - Serum albumin ≤ 3.0 g/dL
    - Serum magnesium < 1.5 mg/dL
    - Serum transaminase (alanine transaminase [ALT] or Serum glutamic pyruvic transaminase [SGPT], aspartate aminotransferase [AST] or serum glutamic oxaloacetic transaminase [SGOT]) > 2.5 times the upper limit of normal (ULN) at screening
    • Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and Investigator’s knowledge.
    • History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects with > 30% reduction from baseline in predialysis iPTH during the efficacy assessment phase (EAP)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the EAP (Week 20 - Week 27 inclusive)
    E.5.2Secondary end point(s)
    • proportion of subjects with predialysis iPTH ≤ 300 pg/mL during the EAP
    • percent change from baseline in predialysis iPTH during the EAP
    • percent change from baseline in predialysis serum cCa during the EAP
    • percent change from baseline in predialysis cCa x P during the EAP
    • percent change from baseline in predialysis serum phosphorus during the EAP
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the EAP (Week 20 - Week 27 inclusive)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA57
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Canada
    France
    Italy
    Austria
    Netherlands
    Sweden
    Australia
    Czech Republic
    Germany
    Hungary
    Spain
    Israel
    Poland
    Russian Federation
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 500
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects may be eligible to participate in an extension study. Otherwise, subjects will return to standard of care treatment.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-09
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