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    Summary
    EudraCT Number:2019-001212-29
    Sponsor's Protocol Code Number:Prot-0824-2019
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-06-09
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2019-001212-29
    A.3Full title of the trial
    Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Causes and prevention of thrombosis developed due to the kidney disease nephrotic syndrome
    A.4.1Sponsor's protocol code numberProt-0824-2019
    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 SponsorAarhus University Hospital, Henrik Birn
    B.1.3.4CountryDenmark
    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 supportNyreforeningen
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDansk Nefrologisk Selskab
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportNyresygdomme, Aarhus University Hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportHelen og Ejnar Bjørnows Fond
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportAugustinus Fonden
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportRegion Midtjyllands Sundhedsvidenskabelige Forskningsfond
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus Universitets Hospital
    B.5.2Functional name of contact pointSarah Kelddal
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul-Jensens BLVD. 99
    B.5.3.2Town/ city8210
    B.5.3.3Post codeAarhus N
    B.5.3.4CountryDenmark
    B.5.6E-mailsarah.kelddal@midt.rm.dk
    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 Fragmin
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer ApS
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDalteparin
    D.3.9.3Other descriptive nameDalteparin
    D.3.9.4EV Substance CodeSUB33617
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number18000
    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.IMP: 2
    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 Eliquis
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Tablet
    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 INNApixaban
    D.3.9.3Other descriptive nameApixaban
    D.3.9.4EV Substance CodeSUB25425
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Nephrotic syndrome is defined as severe proteinuria (> 3.5 g / day), edema and hypoalbuminemia. It is conditioned by a defect in the kidney's glomerular filtration barrier, resulting in the loss of a large number of plasma proteins including coagulation factors and consequently a increased risk of thromboembolic complications. The most frequent cause of nephrotic syndrome is the renal disease membranous nephropathy, which is associated with the greatest risk of thromboembolic complications.
    E.1.1.1Medical condition in easily understood language
    In nephrotic syndrome, the kidney's filtering function is damaged and causes proteins to be lost in the urine, which increases the risk of forming blood clots in eg. legs and lungs.
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10029167
    E.1.2Term Nephrotic syndrome with lesion of membranous glomerulonephritis
    E.1.2System Organ Class 100000004857
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10029165
    E.1.2Term Nephrotic syndrome in diseases classified elsewhere
    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
    This study aims to describe the biochemical coagulation profile and investigate the effect of dalteparin and apixaban on this profile in patients with nephrotic syndrom. More specifically, we will:
    1 Identify abnormalities in the coagulation profile in nephrotic syndrom promoting a prothrombotic state.
    2 Describe the effects of dalteparin on the biochemical coagulation profile in nephrotic syndrom.
    3 Determine the levels of plasma apixaban and its effect on the biochemical coagulation profile in nephrotic syndrom compared with healthy controls.





    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Substudy 1:
    To identify abnormalities in the coagulation profile in nephrotic syndrome 60 patients will be included in substudy 1.

    Inclusion criteria:
    • Age > 18
    • eGFR > 30 mL/min/1,73 m2
    • P-albumin < 30 g/L
    • Stabilized diabetes with hemoglobinA1c < 65 mmol/mol
    • U-albumin excretion > 2.2 g/day
    • Known glomerular disease including membranous nephropathy, which may cause nephroticy syndrom or diagnostically unresolved nephrotic syndrome with a planed kidney biopsy.

    Substudy 2:
    Up to 50 patients from substudy 1 will be treated with dalteparin to describe the effects on the biochemical coagulation profile.

    Inclusion criteria:
    • Age > 18 years
    • eGFR > 30 mL/min/1,73 m2
    • P-albumin < 25 g/L
    • Stabilized diabetes with hemoglobinA1c < 65 mmol/mol
    • U-albumin excretion > 2.2 g/day
    • Known glomerular disease including membranous nephropathy, which may cause nephroticy syndrom or diagnostically unresolved nephrotic syndrome with a planed kidney biopsy.

    Substudy 3:
    To determine the levels of plasma apixaban and its effect on the biochemical coagulation profile in nephrotic syndrome compared to atrial fibrillation patients, 10 patients with nephrotic syndrome and membranous nephropathy will be treated with apixaban and compared to 10 patients with atrial fibrillation.


    Patiens with nephrotic syndrome.
    Inclusion criteria:
    • Age > 18 years
    • eGFR > 30 mL/min/1,73 m2
    • P-albumin < 25 g/L
    • U-albumin excretion > 2.2 g/day
    • One of the following conditions based on a kidney biopsy:
    - Membranous nephropathy
    - Minimal change disease
    - Focal segmental glomerulosclerosis
    • Stabilized diabetes with hemoglobinA1c < 65 mmol/mol


    Healthy controls.
    Inclusion criteria:
    • Age > 18-years
    • eGFR > 30 mL/min/1,73 m2
    • P-albumin > 36 g/lL
    • Stabilized diabetes with hemoglobinA1c < 65 mmol/mol
    • Patients exhibiting indications of infection must have CRP concentration < 30 mg/l
    • U-albumin excretion < 300 mg/day




    E.4Principal exclusion criteria
    Exclusion criteria:
    • Kontraindikation to apixaban.
    • Kontraindikation to dalteparin.
    • Known allergy or intolerance to apixaban.
    • Known allergy or intolerance to dalteparin.
    • Treatment with anticoagulation for other reasons.
    • Treatment with COX-1 inhibitors or ADP receptor inhibitors.
    • Known acquired or congenital coagulation defect not related to nephrotic syndrome or thromboembolic disease within 3 months.
    • Lack of compliance, comorbidity or other conditions that, in the eyes of the inclusive physician, make the patient unfit to participate in the trial.
    • Pregnancy.
    E.5 End points
    E.5.1Primary end point(s)
    Description of the coagulation profile
    1 In patients with nephrotic syndrom, thromboxane B2 (marker of the primary hemostasis) as well as thrombin generation and prothrombin Fragment 1+2 (markers of the secondary hemostasis) are increased compared to healthy controls.
    2 In patients with nephrotic syndrom, the natural anticoagulants are decreased compared to healthy controls.
    3 In patients with nephrotic syndrom, clot lysis and plasminogen activator inhibitor-1 (markers of fibrinolysis) are decreased compared to healthy controls.


    The effects of dalteparin on the biochemical coagulation profile:
    1 In patients with nephrotic syndrom, treatment with dalteparin leads to a decrease in thrombin generation compared with baseline.


    The effects of apixaban on the biochemical coagulation profile:
    1 In patients with nephrotic syndrom, apixaban leads to a decrease in thrombin generation compared with baseline.
    2 The decrease in thrombin generation following apixaban is similar in patients with nephrotic syndrom and healthy controls.
    E.5.1.1Timepoint(s) of evaluation of this end point
    When the last patient is included and has completed the study, the biochemical samples will be analyzed and data will be compiled. Inclusion of patientes is expected to begin September 2020 and end in september 2023.
    E.5.2Secondary end point(s)
    Apixaban:
    1 The plasma and urine concentrations of apixaban in patients with nephrotic syndrom is comparable to the plasma and urine concentration of apixaban in healthy controls.
    2 In patients with nephrotic syndrome the decreases in thrombin generation following dalteparin or apixaban are similar.
    E.5.2.1Timepoint(s) of evaluation of this end point
    When the last patient is included and has completed the study, the biochemical samples will be analyzed and data will be compiled. Inclusion of patientes is expected to begin September 2020 and end in september 2023.
    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 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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pharmacokinetic trial
    Farmakokinetisk studie
    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 No
    E.8.1.2Open Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Blood and urine samples are compared to healthy controls
    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 concerned3
    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 No
    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 project is expected to extend over 36 months.
    Inclusion of patients comences 01.09.2020 with expected completion 01.09.2023.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state80
    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)
    None
    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 Decision2020-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-26
    P. End of Trial
    P.End of Trial StatusOngoing
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