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    Summary
    EudraCT Number:2010-019439-37
    Sponsor's Protocol Code Number:M10-149
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-07-15
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-019439-37
    A.3Full title of the trial
    A Phase 3, Prospective, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Intact Parathyroid Hormone Levels in Pediatric Subjects Ages 10 to 16 years with Moderate to Severe Chronic Kidney Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of Paricalcitol Capsules in decreasing serum parathyroid hormone levels in children 10-16 with Chronic Kidney Disease (CKD)
    A.4.1Sponsor's protocol code numberM10-149
    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 SponsorAbbVie Deutschland 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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointeuclinicaltrials@abbott.com
    B.5.3 Address:
    B.5.3.1Street AddressAbbott House, Vanwall Business Park, Vanwall Road,
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628644475
    B.5.5Fax number+441628644330
    B.5.6E-maileuclinicaltrials@abbott.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 Yes
    D.2.1.1.1Trade name Zemplar 1 microgram capsules, soft
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Ltd.
    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 No
    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) 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 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
    Moderate to Severe Chronic Kidney Disease
    E.1.1.1Medical condition in easily understood language
    Chronic Kidney Disease Stage 3 and 4
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this study are as follows:
    Part I: To determine the safety, tolerability, and pharmacokinetics of a single dose of 3 mcg paricalcitol capsules in pediatric subjects ages 10 to 16 years with moderate to severe chronic kidney disease (CKD Stages 3 and 4).

    Part II: To determine the safety and efficacy of paricalcitol capsules as compared to placebo in decreasing serum iPTH in pediatric subjects ages 10 to 16 years with moderate to severe chronic kidney disease (CKD Stages 3 and 4) with 12 weeks double-blinded study drug and a minimum of 12 weeks open-label active drug.
    E.2.2Secondary objectives of the trial
    To determine the safety and efficacy of paricalcitol capsules as compared to placebo in decreasing serum iPTH in pediatric subjects ages 10 to 16 years with moderate to severe chronic kidney disease (CKD Stages 3 and 4) with 12 weeks double-blinded study drug and a minimum of 12 weeks open-label active drug.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects ≥ 10 years old and ≤ 16 years old.
    2. Subject has voluntarily signed and dated an informed consent form and/or assent, or has had one signed by a parent or legal guardian, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject and/or parent or legal guardian has had the opportunity to ask questions. The informed consent must be signed prior to any study-specific procedures being performed.
    3. Subject has CKD Stage 3 or 4 as determined by eGFR (15 to 59 mL/min/1.73 m2) at Screening.
    4. Part II Subjects who have had a kidney or solid organ transplant ≥ 12 months prior to entry into the Treatment Phase with a stable, therapeutic calcineurin inhibitor drug level (at least two stable levels prior to enrollment into Part II of the study).
    5. Subject has 25-hydroxyvitamin D levels ≥ 30 ng/mL at Screening (Part II Only).
    6. Subject is not expected to begin dialysis for at least 6 months (in the opinion of the investigator).
    7. If taking phosphate binders, the subject has been on a stable dose (same type and regimen) for at least 4 weeks prior to the Screening Phase.
    8. If receiving growth hormone, subject must be receiving it for > 3 months prior to the Screening Phase and expected to continue to receive it throughout the Treatment Phase.
    9. All female subjects must have a negative pregnancy test prior to Treatment.
    10. Female subjects must not be nursing, must use the following methods of contraception upon enrollment, and must continue to use these methods for the duration of the study:
    ● Double barrier method (any two of the following: condoms, contraceptive sponges, diaphragm, vaginal ring with spermicidal jellies or creams, or intrauterine device [IUD]).
    ● Hormonal contraceptives (oral, parenteral or transdermal) for 3 months prior to study drug administration.
    ● Females on stable (same dose and product for 3 months) estrogen or progestin therapy (not for contraception).
    ● Total abstinence from sexual intercourse during the study (minimum one complete menstrual cycle prior to study start).
    11. To satisfy the Screening criteria (for subjects who are currently on a VDRA and need to complete a 2–4 week washout), the subject must have:
    ● eGFR between 15 to 59 mL/min/1.73 m2 (estimate by the Schwartz formula as outlined in Section 5.3.1.2).
    ● iPTH measurement that is ≥ 60 pg/mL (Stage 3 subjects) or ≥ 90 pg/mL (Stage 4 subjects).
    ● An adjusted serum calcium value ≥ 8.2 mg/dL (2.05 mmol/L) to ≤ 10.5 mg/dL (2.63 mmol/L).
    ● A serum phosphorus value ≥ 2.0 mg/dL (0.65 mmol/L) to ≤ 6.0 mg/dL (1.94 mmol/L).
    12. For entry into the Treatment Phase (VDRA naïve subjects and those who have completed a 2–4 week washout), the subject must have:
    ● iPTH measurement that is ≥ 75 pg/mL (Stage 3 subjects) or ≥ 110 pg/mL (Stage 4 subjects).
    ● An adjusted serum calcium value ≥ 8.4 mg/dL (2.10 mmol/L) to ≤ 10.2 mg/dL (2.55 mmol/L).
    ● A serum phosphorus value ≥ 2.5 mg/dL (0.81 mmol/L) to ≤ 5.8 mg/dL (1.87 mmol/L).
    ● Must have Vitamin 25D level that is ≥ 30 ng/mL (Part II Only).
    E.4Principal exclusion criteria
    1. Subject has a history of an allergic reaction or significant sensitivity to paricalcitol or to drugs similar to the study drug.
    2. Part I Subjects: All transplants except bone marrow transplant recipients (off immunosuppressant therapy).
    3. Subjects who have had a small bowel transplant.
    4. Subject has had acute kidney failure within 12 weeks of the Screening Phase (defined as an acute rise in serum creatinine).
    5. Subject has had symptomatic or significant hypocalcemia requiring active Vitamin D therapy (i.e., calcitriol, paricalcitol, doxercalciferol or alfacalcidol) within 6 months prior to the Screening Phase.
    6. Subject has a history of active kidney stones (6 months prior to screening).
    7. Subject has chronic gastrointestinal disease, which in the investigator's opinion may cause significant gastrointestinal malabsorption.
    8. Subject is taking maintenance calcitonin, bisphosphonates, cinacalcet,
    glucocorticoids in an equivalent dose of > 5 mg prednisone daily, or other drugs known to affect calcium or bone metabolism within 4 weeks prior to Treatment.
    9. Subject is taking phosphate supplements.
    10. Subject has a current malignancy (except for basal/squamous cell carcinoma) or clinically significant liver disease, in the opinion of the investigator.
    11. Subject weighs < 25 kg (55 lbs.).
    12. Subject has a history of illicit drug and/or alcohol abuse within 6 months prior to the Screening Phase or a positive urine drug test at Screening. Positive urine drug tests at screening which are due to controlled drugs prescribed for a medical need are not exclusionary.
    13. Subject has evidence of poor compliance with diet or medication that may interfere, in the investigator's opinion, with adherence to the protocol.
    14. Subject has received any investigational drug within 4 weeks prior to the Screening Phase.
    15. Subject is known to be HIV positive.
    16. For any reason, subject is considered by the investigator to be an unsuitable candidate (i.e., unable to swallow capsules, lack of a telephone) to receive paricalcitol capsules or is put at risk by the study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of subjects who achieve two consecutive ≥ 30% reductions from baseline in iPTH levels during the 12-week double-blind portion of the study regardless of CKD stage.

    The primary safety variable is the incidence of clinically meaningful hypercalcemia (2 consecutive serum calcium values > 10.2 mg/dL [2.55 mmol/L]).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy endpoint evaluated at 12 weeks. Safety assessments will be evaluated throughout the study, including Follow-Up.
    E.5.2Secondary end point(s)
    Secondary efficacy variables include:
    1. The proportion of subjects who achieve a final iPTH value within K/DOQI iPTH target ranges (Table 6) will be evaluated within each CKD stage.
    2. The mean change in iPTH from baseline to each post baseline visit (Weeks 2, 4, 8 and 12).
    3. The proportion of subjects who achieve a final value within the applicable K/DOQI target ranges for calcium and for phosphorus. K/DOQI recommends serum calcium is maintained within age appropriate normal ranges and serum phosphorus is maintained at or above the age appropriate lower limits and no higher than the age appropriate upper limits.
    4. The mean change in FMV UACR from baseline to each post baseline visit (Weeks 4, 8 and 12).

    The following safety evaluations will be performed during the PK study: adverse event monitoring and vital signs, physical examinations, ECGs and laboratory tests assessments. In Part II safety will also be assessed through SAE and adverse event monitoring, changes from baseline in chemistry, hematology and urinary laboratory variables, changes from baseline in vital signs and physical examinations and progressive changes in kidney function observed via changes in eGFR in conjunction with cystatin C levels and subjects requiring dialysis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy endpoints evaluated at weeks 2, 4, 8 and 12. Safety assessments will be evaluated throughout the study, including Follow-Up.
    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 Yes
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    12 week double-blinded followed by 12 week open label
    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 EEA20
    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
    Germany
    Portugal
    Singapore
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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
    The end-of-study is defined as the date of the last subject's last visit.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    F.1.1Number of subjects for this age range: 36
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 11
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 25
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    A parent or guardian will provide consent for the child
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 36
    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 who complete/discontinue the study will be treated in accordance with the Investigator's best clinical judgment. The Investigator will discuss treatment options with the patient.
    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 Decision2010-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-22
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