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    Summary
    EudraCT Number:2007-006274-29
    Sponsor's Protocol Code Number:ZEMPLAR
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-09-22
    Trial 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 ConcernedSweden - MPA
    A.2EudraCT number2007-006274-29
    A.3Full title of the trial
    Sympathetic activation, microcirculation, haemostasis and inflammation in diabetic and non-diabetic kidney disease: disease modification by vitamin D receptor activation
    A.3.2Name or abbreviated title of the trial where available
    VDRA and CKD
    A.4.1Sponsor's protocol code numberZEMPLAR
    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 SponsorKarolinska Institutet at Danderyd University Hospital
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 holderAbbot Scandinavia AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameZemplar
    D.3.4Pharmaceutical form Capsule*
    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.3.10 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*
    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
    Patients with mild to moderate chronic renal failure (CRF; GFR 15-60ml/min; n=26)
    Patients with mild to moderate CRF and coexisting Diabetes Mellitus (n=26)
    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 12.0
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The major goal of this study is to develop an enhanced understanding of the disturbances involved in how a progressive loss of kidney function cause increased cardiovascular disturbance, disease and ultimately death, and if some of these disturbances can be ameliorated and modified by treatment with a VDRA. Furthermore, evidence suggest that Diabetic kidney disease constitute a separate entity with certain characteristics that may respond differently to treatment with VDRA. Thus we intend to compare diabetic kidney disease with non-diabetic.
    As kidney disease is characterized by increased neurohormonal activation and sympathetic overactivity, the primary outcome variable will be a change (reduction) in sympathetic activity as measured by a tungsten microelectrode inserted percutaneously into a fascicle of the peroneal nerve at the level of the fibular head (muscle sympathetic nerve activity: MSNA).
    E.2.2Secondary objectives of the trial
    A) To determine whether sympathetic overactivity cause sympathovagal imbalance, reflected in altered heart rate variability, disturbed baroreflex regulation, and altered transfer-function between blood pressure and sympathetic nerve activity? May these disturbances be ameliorated by treatment with VDRA?
    B) Endothelial dysfunction and increased arterial stiffness are common features in severe renal failure, and have been shown even before diagnosis in DM-II. To which degrees are they present in mild to moderate CKD, and how do they correlate with other physiological changes? May these disturbances be modified by treatment with VDRA?
    C/ Several factors involved in haemostasis and inflammation are independent risk factors for mortality in patients with end stage renal disease. Is the haemostasis disturbed in mild to moderate CKD, and if so, is this correlated to sympathetic activation and impaired microcirculatory control? May these disturbances be ameliorated by treatment with VDRA?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Man or woman above 20 years of age.
    If woman in reproductive age: not nursing and not pregnant (preseting a negative pregnancy test), and on anticonception therapy.
    Calculated GFR between 15-59 mL/min/1.73m2 using MDRD
    S-Ca2+ <2.6 mmol/L
    iPTH between 35-500 pg/mL
    Serum albumin > 3.0 g/dL
    Signed informed consent

    For inclusion in the diabetes study group:
    • Diagnosed type II diabetes, and treated with peroral antidiabetics or insulin the last 12 months
    • HbA1c <= 12%
    E.4Principal exclusion criteria
    Changes in ACE-inhibitor medication or ARB within 8 weeks before start of the study.

    Nefrotic syndrome
    Expected need for dialysis within 6 months after study start
    Vitamin D treatment within 6 months before start of the study.
    Poorly controlled hypertension with blood pressure >150/100 mmHg (repeated measurements after 15 minutes rest)
    Concomitant treatment with drugs affecting bone and calcium metabolism such as kalcitonin, cinacalcet (Mimpara or Parareg), and high dose corticosteroids.
    Concomitant treatment with drugs inhibiting or inducing Cytokrom P450 3A.
    Known hypersensitivity to any of the substances in study drug or placebo.
    Diabetic nefropathy and concurrent glomerulonefritis or nefritis
    Acute renal failure within 12 weeks before screening
    Other severe chronic disease (AIDS/HIV-positive, cancer, severe heart failure etc.)
    Known kidney artery stenosis
    Known kidney stone disease
    Intake of other investigational medicinal product within 30 days before screening.
    Known alcohol or drug abuse
    Known low compliance
    Not suitable for participation for other reason according to investigators opinion.
    E.5 End points
    E.5.1Primary end point(s)
    Sympathetic activation measured by microneurography at the conclusion of the 12 weeks treatment period.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Study of patophysiological mechanisms.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    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 months6
    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 months6
    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 state76
    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)
    One extra calcium level control after 4 weeks after the conclusion of the study. Othervise regular treatment and follow-up, as provided by our Out-Patients Clinic.
    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 Decision2009-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-11
    P. End of Trial
    P.End of Trial StatusOngoing
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