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    Summary
    EudraCT Number:2013-000819-25
    Sponsor's Protocol Code Number:43712
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-08-15
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-000819-25
    A.3Full title of the trial
    Autologous BM derived MSCs in combination with everolimus to preserve renal structure and function in renal recipients
    Autologe therapie met mesenchymale stromale cellen verkregen uit het beemnerg in combinatie met everolimus om nierstructuur en functie te behouden in niertransplantaat ontvangers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MSCs therapy in renal recipients
    MSC therapie in niertransplantaatontvangers
    A.4.1Sponsor's protocol code number43712
    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 SponsorLeiden University Medical Center
    B.1.3.4CountryNetherlands
    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 supportLUMC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLUMC
    B.5.2Functional name of contact pointClinical trials information LUMC ne
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2300RC
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31715262148
    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 namebone marrow derived mesenchymal stromal cells
    D.3.4Pharmaceutical form 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 INNmesenchymal stromal cells
    D.3.9.1CAS number n.a.
    D.3.9.2Current sponsor coden.a.
    D.3.9.3Other descriptive namen.a.
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1000000 to 2000000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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
    renal recipients
    niertransplantaatontvangers
    E.1.1.1Medical condition in easily understood language
    patient who received a renal transplant
    niertransplantaatontvangers
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    A 6-month study of efficacy and safety comparing concentration-controlled Certican® with MSCs to Certican® with standard tacrolimus in renal transplant recipients

    Patients of the MSC treated groups will receive two doses of autologous bone marrow (BM) derived MSCs IV, 7 days apart, 6 and 7 weeks after transplantation in combination with Certican® (1.5 mg/day). At the time of the second MSC infusion tacrolimus will be withdrawn in 2 weeks (after 1 week dose of tacrolimus will be halved, after 2 weeks stopped). Doses of MSCs will be 1-2x106 million MSCs per/kg body weight. Patients in the control group will receive Certican® (1.5 mg/day) and standard dose tacrolimus (through levels 6-8 ng/ml after 6 weeks).

    The primary end point is to compare fibrosis by quantitative Sirius Red scoring of MSC treated and untreated groups at 6 months compared
    to 4 weeks post transplant.
    Een 6 maand durende studie hetgeen de effectiviteit en veieligheid vergelijkt tussen concentratie-gecontroleerd Certican® met MSCs tov Certican® met standaard dosis tacrolimus in niertransplantaat ontvangers

    Vergelijking van fibrose door kwantitatieve Sirius Red scoring in MSC behandelde en onbehandelde groep op 6 maanden vergeleken met 4 weken na transplantatie
    E.2.2Secondary objectives of the trial
    Composite end point efficacy failure (Biopsy Proven Acute Rejection (BPAR), graft loss, death or loss to follow-up) at 6 months; renal function measured by cGFR (MDRD formula and iohexol clearance) and proteinuria at 6 months; CMV and BK infection (viremia, disease and syndrome); adverse events; the presence of donor specific antibodies (DSA) and immune monitoring in the different treatment groups; to compare the progression of "subclinical" cardiovascular disease in the different treatment groups by assessing echocardiography and pulse wave velocity.
    Eind punt effectiviteit falen (Biopsy Proven Acute Rejection (BPAR), graft verlies, dood of verlies follow-up) op 6 maaden; nierfucntie gemeten met cGFR (MDRD formule en iohexol) en proteinuria op 6 maanden; CMV and BK infectie (viremia, ziekte en syndroom); adverse events; the aanwezigheid van donor specifieke antibodies (DSA) en immune monitoring in de verschillende behandelgroepen; progressie van "subklinische" cardiovasculaire ziekte in de verschillende groepen dmv echocardiography and pulse wave velocity.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female or male, aged between 18 and 75 years.
    2. Subject is willing to participate in the study, must be able to give informed consent and the consent must be obtained prior to any study procedure.
    3. Recipients of a first kidney graft from a deceased, living-unrelated or non-HLA identical living related donor > 50 years of age.
    4. Panel Reactive Antibodies (PRA) ≤ 10%.
    5. Patients must be able to adhere to the study visit schedule and protocol requirements.
    6. If female and of child-bearing age, subject must be non-pregnant, non-breastfeeding, and use adequate contraception.
    1. Man/vrouw, tussen 18 en 75 jaar
    2. Bereid zijn mee te doen aan de studie, mogelijkheid informed consent te geven hetgeen verkregen meot zijn voor de studie
    3. Ontvangers van een eerste niertransplantaat, van een overleden, of levende noet HLA identieke levende donor> 50 jaat
    4. PRA <10%
    5. Patienten moeten het studieschema kunnen volgen en de protocol eisen
    6. Geen zwangerschap, adequate anticonceptie
    E.4Principal exclusion criteria
    1. Double organ transplant recipient.
    2. Biopsy proven acute rejection (according to the Banff criteria) after transplantation.*
    3. Patients with evidence of active infection or abscesses (with the exception of an uncomplicated urinary tract infection) before MSC infusion.*
    4. Patients suffering from hepatic failure.*
    5. Patients suffering from an active autoimmune disease.*
    6. Patients who have had a previous BM transplant.
    7. A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study.
    8. Use of any investigational drug after transplantation.
    9. Documented HIV infection, active hepatitis B, hepatitis C or TB according to current transplantation inclusion criteria.*
    10. Subjects who currently an active opportunistic infection at the time of MSC infusion (e.g., herpes zoster [shingles], cytomegalovirus (CMV), Pneumocystis carinii (PCP), aspergillosis, histoplasmosis, or mycobacteria other than TB, BK) after transplantation.*
    11. Malignancy (including lymphoproliferative disease) within the past 2-5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence) according to current transplantation inclusion criteria.
    12. Known recent substance abuse (drug or alcohol).*
    13. Contraindications to undergo a BM biopsy.
    14. Patients who are recipients of ABO incompatible transplants.
    15. Cold ischemia time >30 hrs.
    16. Patients with severe total hypercholesterolemia or total hypertriglyceridemia (patients on lipid lowering treatment with controlled hyperlipidemia are acceptable).*
    1. Double organ transplant recipient.
    2. Biopsy proven acute rejection (according to the Banff criteria) after transplantation.*
    3. Patients with evidence of active infection or abscesses (with the exception of an uncomplicated urinary tract infection) before MSC infusion.*
    4. Patients suffering from hepatic failure.*
    5. Patients suffering from an active autoimmune disease.*
    6. Patients who have had a previous BM transplant.
    7. A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study.
    8. Use of any investigational drug after transplantation.
    9. Documented HIV infection, active hepatitis B, hepatitis C or TB according to current transplantation inclusion criteria.*
    10. Subjects who currently an active opportunistic infection at the time of MSC infusion (e.g., herpes zoster [shingles], cytomegalovirus (CMV), Pneumocystis carinii (PCP), aspergillosis, histoplasmosis, or mycobacteria other than TB, BK) after transplantation.*
    11. Malignancy (including lymphoproliferative disease) within the past 2-5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence) according to current transplantation inclusion criteria.
    12. Known recent substance abuse (drug or alcohol).*
    13. Contraindications to undergo a BM biopsy.
    14. Patients who are recipients of ABO incompatible transplants.
    15. Cold ischemia time >30 hrs.
    16. Patients with severe total hypercholesterolemia or total hypertriglyceridemia (patients on lipid lowering treatment with controlled hyperlipidemia are acceptable).*
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is to compare fibrosis by quantitative Sirius Red scoring of MSC treated and untreated groups at 6 months compared
    to 4 weeks post transplant.
    Vergelijking van fibrose door kwantitatieve Sirius Red scoring in MSC behandelde en onbehandelde groep op 6 maanden vergeleken met 4 weken na transplantatie
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after renal transplantation
    6 months after renal transplantation
    E.5.2Secondary end point(s)
    Composite end point efficacy failure (Biopsy Proven Acute Rejection (BPAR), graft loss, death or loss to follow-up) at 6 months; renal function measured by cGFR (MDRD formula and iohexol clearance) and proteinuria at 6 months; CMV and BK infection (viremia, disease and syndrome); adverse events; the presence of donor specific antibodies (DSA) and immune monitoring in the different treatment groups; to compare the progression of "subclinical" cardiovascular disease in the different treatment groups by assessing echocardiography and pulse wave velocity.
    Eind punt effectiviteit falen (Biopsy Proven Acute Rejection (BPAR), graft verlies, dood of verlies follow-up) op 6 maaden; nierfucntie gemeten met cGFR (MDRD formule en iohexol) en proteinuria op 6 maanden; CMV and BK infectie (viremia, ziekte en syndroom); adverse events; the aanwezigheid van donor specifieke antibodies (DSA) en immune monitoring in de verschillende behandelgroepen; progressie van "subklinische" cardiovasculaire ziekte in de verschillende groepen dmv echocardiography and pulse wave velocity.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months after transplantation, and time points in between as described in the protocol
    6 maanden na niertransplantatie , en ertussen in zoals beschreven in het protocol
    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 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 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
    zie hierboven
    Patients of the MSC treated groups will receive two doses of autologous bone marrow (BM) derived MSC
    E.8.2.4Number of treatment arms in the trial2
    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 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
    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 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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state70
    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)
    Standard care for renal transplant recipients
    Niertransplantatieontvangers
    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 Decision2013-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-22
    P. End of Trial
    P.End of Trial StatusOngoing
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