Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43843   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2007-001689-34
    Sponsor's Protocol Code Number:M10-030
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-12
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2007-001689-34
    A.3Full title of the trial
    The PRIMO Study: Paricalcitol Capsules benefits in Renal failure Induced cardiac Morbidity in Subjects with Chronic Kidney Disease Stage 3B/4.
    Estudio Primo: Beneficios de Paricalcitol cápsulas sobre la morbilidad cardíaca provocada por la insuficiencia renal en los sujetos con enfermedad renal crónica en estadios 3B/4.
    A.3.2Name or abbreviated title of the trial where available
    PRIMO I
    A.4.1Sponsor's protocol code numberM10-030
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAbbott GmbH & Co. KG
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.1.1.1Trade name Zemplar
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNparicalcitol
    D.3.9.1CAS number 131918-61-1
    D.3.9.2Current sponsor codeABT-358
    D.3.9.3Other descriptive name(7E,22E)-19-Nor-9,10-secoergosta -5,7,22-triene-1α,3β,25-triol
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Stage 3B/4 chronic kidney disease (CKD) in subjects who have left ventricular hypertrophy (LVH).
    Insuficiencia renal crónica en estadío 3B/4 en sujetos con hipertrofia ventricular izquierda.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10049773
    E.1.2Term Left ventricular hypertrophy
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effects of paricalcitol capsules on progression or regression of LVH in subjects with Stage 3B/4 CKD compared to placebo, as assessed by comparing changes in LV Mass Index (LVMI) over 48 weeks measured by sequential cardiac magnetic resonance imaging (MRI).
    E.2.2Secondary objectives of the trial
    To evaluate the following:

    1. Echocardiographic assessment of diastolic function will be assessed by evaluating
    changes in diastolic mitral annular relaxation velocity (E') and changes in
    additional measures of diastolic function (IVRT, E/E', DT).

    2. Changes in biological and inflammatory markers that have been linked to CVD in
    CKD subjects. Specifically, the markers to be evaluated will include plasma
    triiodothyronine (T3), interleukin-6 (IL-6), troponin-T, B-type natriuretic peptide
    (BNP) and high sensitivity C-reactive protein (hsCRP).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    DNA and RNA samples from this protocol may be used to study genetic factors
    contributing to paricalcitol responses for both primary and secondary endpoints as well as safety response. Genetic studies may include genes related to the metabolism, transport, therapeutic response and adverse events of paricalcitol.
    Please refer to Section 5.3.5 of the study protocol for further information.
    E.3Principal inclusion criteria
    Subjects must meet all of the following criteria:

    1. Subject has voluntarily signed and dated an informed consent form, approved by
    an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after
    the nature of the study has been explained and the subject has had the opportunity
    to ask questions. The informed consent must be signed before any study-specific
    procedures are performed.
    2. Male or female subjects between 18 and 75 years.
    3. For entry into the Treatment Period the subject must satisfy the following criteria
    based on the Screening laboratory values:
    ● Estimated GFR between 15-50 ml/min/1.73m2 by simplified 4-variable
    Modification of Diet in Renal Disease (MDRD) formula (this includes a 10%
    variation in the upper limit of eGFR that will be allowed for the enrollment of
    subjects, this is to account for variability in the creatinine assay).
    ● Serum iPTH value between 50-300 pg/mL.
    ● Corrected serum calcium level 8.0-10.0 mg/dL (2.0-2.5 mmol/L).
    ● Phosphorous level ≤ 5.2 mg/dL (1.68 mmol/L).
    ● Serum albumin ≥ 3.0 g/dL (30 g/L).
    ● Negative serum pregnancy test for female subjects of childbearing potential.
    4. For entry into the Treatment Period the subject must satisfy the following criteria
    based on the Screening echocardiogram:
    ● For females, LV ejection fraction ≥ 50% and septal wall thickness between
    12-15 mm; and,
    ● For males, LV ejection fraction ≥ 50% and septal wall thickness between
    13-16 mm.
    5. In the opinion of the investigator, the subject must be receiving optimal medical
    management of left ventricular hypertrophy and CKD including appropriate use of
    RAAS inhibitors (ACEi, ARB or aldosterone inhibitor) if indicated by the subject's
    medical condition.
    6. If the subject is receiving RAAS inhibitors the dose must have been stable for at
    least three months prior to the Screening Period. However, subject may have
    switched to different brands but at equivalent doses as determined by the study
    physician during the three months prior to the Screening Period.
    7. Subject must have a technically adequate baseline cardiac MRI.
    8. If female, subject is not breast feeding or is not pregnant (verified by negative
    pregnancy test prior to the Treatment Period); or is not of childbearing potential,
    defined as postmenopausal for at least one year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy); or is of childbearing potential
    and practicing one of the following methods of birth control:
    ● Double-barrier method (condoms, contraceptive sponge, diaphragm, vaginal
    ring with spermicidal jellies or creams, or intrauterine device [IUD])
    ● Hormonal contraceptives (oral, parenteral, or transdermal) for at least
    three months prior to and during study drug administration
    ● Maintains a monogamous relationship with a vasectomized partner
    ● Total abstinence from sexual intercourse during the study (minimum
    one complete menstrual cycle prior to study start).
    E.4Principal exclusion criteria
    Subjects must not meet any of the following criteria:

    1. Subject has previously been on prescription-based vitamin D therapy within the
    three months prior to the Screening Period.
    2. Subject has a history of an allergic reaction or significant sensitivity to paricalcitol
    or to drugs similar to the study drug (i.e. vitamin D or vitamin D related
    compounds).
    3. Pregnant (confirmed by screening pregnancy test) or lactating females.
    4. Subject is expected to initiate renal replacement therapy within one year.
    5. Subject is expected to receive a new or increased dose of RAAS inhibitor (ACEi,
    ARB or aldosterone inhibitor) during the course of the study.
    6. Subject has clinically significant coronary artery disease (CAD) within 3 months
    prior to the Screening Period, defined as one of the following:
    ● Hospitalization for MI or unstable angina; or
    ● New onset angina with positive functional study or coronary angiogram
    revealing stenosis; or
    ● Coronary revascularization procedure.
    7. Subject has major cardiac valve abnormality linked with LVH and/or diastolic
    dysfunction, defined as one of the following:
    ● Aortic valve area ≤ 1.5 cm2 or a mean gradient of > 20 mm Hg; or
    ● Regurgitation lesions; more than moderate mitral regurgitation or more than
    moderate aortic regurgitation.
    8. Subject has asymmetric septal hypertrophy defined as septal wall
    thickness/posterior wall thickness ratio > 1.5 based on screening echocardiogram.
    9. Subject has had a severe cerebrovascular accident (CVA) within last 3 months
    (e.g. hemorrhagic) prior to screening.
    10. Full remission from a malignancy for less than one year or any history of bone
    metastasis.
    11. Subject has co-morbid conditions (e.g. advanced malignancy, advanced liver
    disease) with a life expectancy less than 1 year.
    12. Subject has received any investigational drug within 30 days prior to study drug
    administration or is currently enrolled in another clinical trial.
    13. Subject has a history of kidney stones.
    14. Subject has poorly controlled hypertension (systolic blood pressure > 180 mmHg
    and/or diastolic blood pressure > 110 mmHg at the Screening Visit (confirmed by
    repeat).
    15. Subject has secondary hypertension (i.e. renal artery stenosis, primary
    aldosteronism or pheochromocytoma).
    16. Subject is taking calcitonin, bisphosphonates, cinacalcet, glucocorticoids (except
    topical or inhaled glucocorticoids), or other drugs that may affect calcium or bone
    metabolism, other than calcium containing phosphate binder or female subjects on
    stable (same dose and product for three months) estrogen and/or progestin therapy.
    17. Subject is currently receiving immunosuppressant therapy and/or high doses
    (non-maintenance therapy) of steroids (≥ 5 mg/day of prednisone or equivalent).
    18. Subject has had acute renal failure within 12 weeks of the Screening Phase defined by an acute rise in serum Cr (of at least 0.5 mg/dL or 44 mmol/L) to more than 4 g/dL (350 mmol/L).
    19. Subject is known to be HIV positive.
    20. Use of known inhibitors (i.e., ketoconazole) or inducers (i.e., carbamazepine) of
    cytochrome P450 3A (CYP3A) within two weeks prior to study drug
    administration.
    21. Subject is contraindicated for the MRI examination (i.e., pacemaker).
    22. For any reason, subject is considered by the Investigator to be an unsuitable
    candidate to receive paricalcitol capsules or is put at risk by study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in LVMI over 48 weeks measured by cardiac MRI. Left Ventricular Mass will be normalized to the subject's height by the following equation to obtain LVMI: LVM (g) divided by height (m)2.7.
    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 No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    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.8.3 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 220
    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)
    No additional treatment will be provided after the end of the study. The subject will return to their normal standard of care.
    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 Decision2008-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-03-08
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 18 06:46:08 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA