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    The EU Clinical Trials Register currently displays   43233   clinical trials with a EudraCT protocol, of which   7153   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).

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    EudraCT Number:2015-002345-64
    Sponsor's Protocol Code Number:181501
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-09-08
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2015-002345-64
    A.3Full title of the trial
    A Phase 2 Study to Assess the Efficacy and Safety of Intravenous Infusion with Human Soluble Recombinant Fc-gamma Receptor IIB (SM101/BAX 1810) in Subjects with Immunoglobulin A Nephropathy (IgAN)
    Klinické hodnocení fáze 2 posuzující účinnost a bezpečnost nitrožilní infuze lidského rozpustného rekombinantního Fc-gama receptoru IIB (SM101/BAX 1810) u pacientů s nefropatií s ukládáním depozit z imunoglobulinu A (IgAN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of SM101 in the Treatment of IgA Nephropathy
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and Safety of SM101 in the Treatment of IgA Nephropathy
    Účinnost a bezpečnost SM101 v léčbě IgA nefropatie
    A.4.1Sponsor's protocol code number181501
    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 SponsorBaxalta Innovations GmbH
    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 supportBaxalta Innovations GmbH
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBaxalta Innovation GmbH
    B.5.2Functional name of contact pointClinical Development
    B.5.3 Address:
    B.5.3.1Street AddressIndustriestrasse 67
    B.5.3.2Town/ cityVienna
    B.5.3.3Post codeA-1221
    B.5.4Telephone number+43 120 1002472930
    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.3.2Product code SM101
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeSM101
    D.3.9.3Other descriptive namehuman soluble recombinant Fc-gamma receptor IIB
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    IgA Nephropathy
    E.1.1.1Medical condition in easily understood language
    an autoimmune disease resulting in inflammation of the kidney, which can lead to destruction of the kidneys over time in about a third of the patients
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10021263
    E.1.2Term IgA nephropathy
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of a single treatment cycle of SM101 on the mean percent change in proteinuria from Baseline to Week 24 in subjects with IgAN
    E.2.2Secondary objectives of the trial
    1. To assess the safety and tolerability of SM101 in subjects with IgAN
    2. To compare the relative efficacy and safety of 12 mg/kg and 24 mg/kg doses of SM101 in the treatment of IgAN
    3. To assess the effect of SM101 on renal function, as determined by estimated glomerular filtration rate (eGFR)
    4. To compare the effect of treatment with SM101 on the level of IgAN-specific biomarkers
    5. To assess the pharmacokinetics (PK) of SM101 in subjects with IgAN
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is 18 years of age or older at the time of Screening.
    2. Subject may be of either gender and of any race or ethnicity.
    3. Subject must have a biopsy-proven diagnosis of IgAN (obtained within 8 years
    prior to Screening).
    4. Subject’s blood pressure is ≤130/80 mmHg at Screening.
    5. Subject is on maximally tolerated dose of an angiotensin-converting enzyme (ACE) inhibitor and/or angiotensin receptor blocker (ARB) for at least 3 month prior to Baseline visit.
    6. Subject must present at Screening with current proteinuria levels between 1 g/24 h and 3.5 g/24 h.
    7. Subject must present at Screening with eGFR [CKD-EPI] >40 mL/min/1.73m2.
    8. If a female of childbearing potential, subject must have a negative pregnancy test at Screening, is not currently breastfeeding, and agrees to employ adequate birth control measures for the duration of the study. Male subjects with female partners of childbearing potential must agree to use adequate birth control measures for the duration of the study.
    9. Subject is willing and able to comply with the requirements of this protocol and
    agrees to sign an informed consent form prior to any study-related activities.
    E.4Principal exclusion criteria
    1. Subject has a history or current evidence of renal disease other than IgAN
    2. Subjects with evidence of rapidly progressive disease (defined as a decline in
    eGFR of ≥5 mL/min/1.73m2 in the preceding 6 months prior to Baseline)
    3. Subject has IgAN with histologic evidence of advanced tubular atrophy and
    interstitial fibrosis (eg, Oxford T2)
    4. History or current evidence of other autoimmune disease (eg, SLE, inflammatory
    bowel disease, rheumatoid arthritis)
    5. History or current evidence of any chronic or uncontrolled medical condition (eg,
    diabetes, severe hepatic or cardiovascular disease, alcohol or drug addiction)
    which could, in the opinion of the Investigator, affect the subject’s safety and
    ability to adhere to this protocol, or otherwise confound the results of the study
    6. History or current evidence of a severe acute (ie, within 4 weeks prior to
    Baseline) or chronic infection (eg, HIV, hepatitis B or C, tuberculosis, systemic
    fungal infection [active or latent])
    7. Use of systemic corticosteroids within 3 months prior to Baseline, or anticipated
    use during the treatment period (Week 1 through Week 4). Note: Corticosteroids
    administered by inhalation or intranasally, or limited topical use of low-potency
    topical corticosteroids (ie, Class 6 and 7) are allowed throughout the study.
    8. Known hypersensitivity or allergic reaction to any E. coli-derived recombinant
    product, or to the IP or any of its excipients
    9. Treatment with any immunomodulatory/immunosuppressive compound or
    monoclonal antibody for any indication within 6 months (unless otherwise
    stated) prior to Screening (eg, B cell-depleting agents [eg, rituximab,
    epratuzumab] for ≥48 weeks; B-cell modifying agents [eg, belimumab, atacicept]
    for ≥24 weeks; IV immunoglobulins for ≥12 weeks and all other
    immunosuppressive treatments [eg, methotrexate, cyclophosphamide,
    cyclosporine, tacrolimus, mycophenolate mofetil, azathioprine] for ≥12 weeks)
    10. Clinically significant laboratory abnormalities prior to Baseline (eg, absolute
    neutrophil count <1000 cells/μL; platelet count <100,000/μL; hemoglobin ≤10
    g/dL; aspartate aminotransferase [AST], and alanine aminotransferase [ALT] ≥3
    times the upper limit of normal)
    11. History of any malignancy within past 5 years prior to Screening (except for
    basal and squamous cell carcinomas of the skin, in situ cervical cancer, and
    stable prostate cancer that does not require treatment)
    12. History of tonsillectomy within 2 months prior to Screening
    13. Subject has participated in another clinical study involving an IP or
    investigational device within 30 days prior to Screening or is scheduled to
    participate in another clinical study involving an IP or investigational device
    during the course of this study
    14. Subject is a family member or employee of the Investigator
    15. A female subject who is pregnant or nursing at the time of Screening
    E.5 End points
    E.5.1Primary end point(s)
    To assess the efficacy of a single treatment cycle of SM101 on the mean percent change in proteinuria from Baseline to Week 24 in subjects with IgAN
    1. Pooled high-dose SM101 and low-dose SM101 versus placebo
    2. High-dose SM101 versus placebo
    3. Low- dose SM101 versus placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    1. Pooled high-dose SM101 and low-dose SM101 versus placebo (testing via 2x2
    table by pooling high- and low-dose SM101 into single column, using placebo
    as the second column).
    2. High-dose SM101 versus placebo (testing via 2x2 table, using only SM101
    high-dose and placebo)
    3. Low- dose SM101 versus placebo (testing via 2x2 table, using only SM101
    low-dose and placebo)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24
    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 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. 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Czech Republic
    Hong Kong
    United Kingdom
    United States
    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 years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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 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: 46
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 31
    F.4.2.2In the whole clinical trial 51
    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 the 24-week randomized, double-blind study, and who meet additional eligibility criteria, will be allowed to participate in an open-label continuation study to assess the long-term effect of treatment with SM101 on proteinuria and renal function (assessed by changes in eGFR over time). Additional study drug administration will be considered based on progression of disease and on availability of the investigational product (IP).
    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 Decision2015-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-12-10
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