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    Summary
    EudraCT Number:2012-001923-11
    Sponsor's Protocol Code Number:Nef-202
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-09-03
    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 ConcernedSweden - MPA
    A.2EudraCT number2012-001923-11
    A.3Full title of the trial
    A Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal disease
    A.3.2Name or abbreviated title of the trial where available
    The NEFIGAN Trial
    A.4.1Sponsor's protocol code numberNef-202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01738035
    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 SponsorPharmalink AB
    B.1.3.4CountrySweden
    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 supportPharmalink AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmalink
    B.5.2Functional name of contact pointProject Director (Alex Mercer)
    B.5.3 Address:
    B.5.3.1Street AddressEngelbrekts kyrkogata 7B
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code114 26
    B.5.3.4CountrySweden
    B.5.4Telephone number468411 3005
    B.5.5Fax number468611 3303
    B.5.6E-mailalex.mercer@pharmalink.se
    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 nameNefecon
    D.3.4Pharmaceutical form Modified-release capsule, hard
    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 INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.9.4EV Substance CodeSUB05955MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 placeboModified-release capsule, hard
    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
    Primary IgA nephropathy patients at risk of developing end stage renal disease
    E.1.1.1Medical condition in easily understood language
    Patient with kidney disease that have damage to the kidneys associated with Immunoglobulin A
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10069341
    E.1.2Term Berger's 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
    To evaluate efficacy and safety of two different doses of Nefecon (budesonide) in the treatment of patients with primary IgA nephropathy (IgAN) at risk of developing end-stage renal disease, under rigorous blood pressure control with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin 2 receptor blocker (ARB).
    The Primary efficacy objective is to investigate whether patients on Nefecon (budesonide) achieve a lareger mean reduction in urine protein creatinine ratio (UPCR) compared to patients in placebo during a 9 months trial.
    E.2.2Secondary objectives of the trial
    To evaluate if other urine protein response criteria and other laboratory parameters used to estimate glomerular filtration rate (GFR) are in favour of Nefecon® (budesonide) compared with placebo at 9 months.
    Tertiary Objective:
    To evaluate if other response criteria and time-points are in favour of Nefecon® (budesonide) compared with placebo.
    Safety Objective:
    To evaluate safety in terms of adverse events, changes in vital signs and laboratory tests during the trial.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Screening Inclusion Criteria:
    1. Female or male patients ≥18 years
    2. Biopsy-verified IgA nephropathy
    3. Urine protein creatinine ratio ≥0.5 g/g (56.5 mg/mmol) OR urine protein ≥0.75 g/24 h
    4. Estimated GFR (using CKD-EPI formula (51)) OR measured GFR* ≥50 mL/min per 1.73 m2 OR ≥45 mL/min per 1.73m2 for patients on a maximum recommended or maximum tolerated dose of an ACEI and/or ARB
    5. Willing to change antihypertensive medication regimen if applicable
    6. Willing and able to give informed consent
    Randomisation Inclusion Criteria:
    1. Completion of the Run-in Phase
    2. Urine protein creatinine ratio ≥0.5 g/g (56.5 mg/mmol) OR urine protein ≥0.75 g/24 h
    3. Estimated GFR (using CKD-EPI formula) OR measured GFR ≥45 mL/min per 1.73 m2
    E.4Principal exclusion criteria
    Screening Exclusion Criteria:
    1. Secondary forms of IgA nephropathy as defined by the treating physician (for example, Henoch–Schönlein purpura patients and those with associated alcoholic cirrhosis)
    2. Presence of crescent formation in ≥50% of glomeruli assessed on renal biopsy
    3. Kidney transplanted patients
    4. Severe gastrointestinal disorders (including peptic ulcer disease and inflammatory bowel disease) which may impair drug effect, or other conditions which could modify the effect of the trial drug as judged by the Investigator
    5. Consumption of an investigational drug within 30 days prior to enrolment
    6. Hyperlipidaemia defined as unacceptable levels of lipids according to the discretion of the Investigator
    7. Morbid obesity defined as a body mass index (BMI) >45 kg/m2
    8. Patients currently treated with systemic immunosuppressive or systemic corticosteroid drugs (excluding topical or nasal steroids) or have been previously treated for more than one week within the last 24 months.
    9. Patients currently treated chronically (daily dosing) with inhaled corticosteroid drugs or have previously been treated chronically for more than one month within the last 12 months
    10. For the treatment of IgA nephropathy, patients treated within the last 24 months with either immunosuppressive agents or systemic corticosteroid drugs
    11. Patients unable to take oral medication or intolerant to budesonide or other corticosteroid preparations
    12. Patients with known allergy or intolerance to ACEI and ARB or to any component of the trial drug formulation
    13. Patients with acute or chronic infectious disease incl. hepatitis, HIV positive patients and patients with chronic urinary tract infections
    14. Severe liver disease according to the discretion of the Investigator
    15. Patients with Type 1 or 2 diabetes
    16. Patients with uncontrolled cardiovascular disease as judged by the Investigator
    17. Patients with current malignancy or history of malignancy during the last three years
    18. History or presence of psychological or psychiatric illness (including steroid induced psychosis) which may interfere with the patient´s ability to adhere to the protocol
    19. Patients with untreated osteoporosis
    20. Patients with glaucoma or cataract
    21. Alcohol or drug abuse (present)
    22. Patients unwilling to meet the requirements of the protocol
    23. Other medical or social reasons for exclusion at the discretion of the Investigator
    24. Life expectancy < 1 year
    25. For women only; pregnant or breast feeding or unwilling to use adequate contraception during the trial (only women of child bearing potential)

    Randomisation Exclusion Criteria:
    1. Unacceptable blood pressure defined as a systolic value >160 mm Hg or diastolic >100 mm Hg
    2. eGFR (CKD-EPI method of estimation) loss >30% over the entire duration of the Run-in Phase
    3. Consumption of an investigational drug after screening
    4. Medical or social reasons for exclusion at the discretion of the Investigator
    5. For women only; pregnant or breast feeding or unwilling to use adequate contraception during the trial (only women of child bearing potential)
    6. For men only; unwilling to use adequate contraception during the treatment and follow-up phase of the trial
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint(s):
    The primary endpoint is the mean reduction in UPCR at 9 months compared to baseline UPCR values.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The mean reduction will be measured as ratio of UPCR at 9 months compared to baseline.
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoint(s):
    - Mean change in urine protein, urine albumin creatinine ratio and urine albumin from baseline at Month 9
    - Mean change UPCR, urine protein, UACR, urine albumin from 9 to 12 months
    - Mean change in serum creatinine, chronic kidney disease epidemiology collaboration equation (CKD-EPI) estimated glomerular filtration rate (eGFR), modification of diet in renal disease study equation (MDRD) eGFR and creatinine clearance from baseline at 9 months

    Tertiary Efficacy Endpoint(s)
    - Achieving defined reductions (≥30%, ≥40%, ≥50%) in UPCR, urine protein, UACR and urine albumin at Month 9 compared to baseline
    - Mean change in UPCR, urine protein, UACR and urine albumin from baseline at 1, 3, 6, 10.5 and 12 months
    - Mean change in CKD-EPI from baseline at 1, 3, 6, 10.5, and 12 months
    - Mean change in Cystatin C-based eGFR from baseline at Month 9
    - Proportion of patients with microhematuria at Months 9 and 12

    Exploratory Efficacy Endpoint(s)
    The exploratory analyses listed below are planned but may not be conducted if deemed to be obsolete during later stages of the trial; other exploratory analyses may be added.
    - Percentage change from baseline at 9 and 12 months on exploratory markers/biomarkers
    - Urine and serum total IgA1/2, secretory IgA, IgA kappa/lambda ratios, IgA1 monomer/polymer ratio, IgA1 O-glycosylation, IgA-CD89 immune complex levels
    - Urine IL-6/EGF ratio, NAG, NGAL, KIM-1, RBP levels
    - Serum or plasma IgA anti-gliadin, IgA anti-ovalbumin, IgA anti-BSA, AOPP, MAdCAM-1, NGAL, hsCRP, PDGF-BB, PDGF-DD, mannose binding lectin levels, 25-hydroxycholesterol levels and non-standard complement assays
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy endpoints will be evaluated at 9 to 12 months.
    Tertiary efficacy endpoints will be evaluated from 1 to 12 months depending of the test.
    Exploratory efficacy endpoints at 9 and 12 months.
    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 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.8.2.4Number of treatment arms in the trial3
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 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 years2
    E.8.9.1In the Member State concerned months4
    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 months4
    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: 195
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    Normal treatment in accordance with the general practice.
    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 Decision2012-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-25
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