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    Summary
    EudraCT Number:2012-001352-19
    Sponsor's Protocol Code Number:20120309-01
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-08
    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 ConcernedGermany - PEI
    A.2EudraCT number2012-001352-19
    A.3Full title of the trial
    BE-RELACs-Trial: Biomarkers Explaining RELevance of ACute Rejections
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Biomarkers after kidney transplantation
    A.3.2Name or abbreviated title of the trial where available
    BE-RELACs
    A.4.1Sponsor's protocol code number20120309-01
    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 SponsorMedizinische Hochschule Hannover
    B.1.3.4CountryGermany
    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 supportBristol-Myers Squibb
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDept. Of Nephrology and Hypertensiology
    B.5.2Functional name of contact pointInvestigator
    B.5.3 Address:
    B.5.3.1Street AddressCarl Neuberg Str. 1
    B.5.3.2Town/ cityHannover
    B.5.3.3Post code30625
    B.5.3.4CountryGermany
    B.5.4Telephone number+495115323000
    B.5.5Fax number+495115329358
    B.5.6E-mailblume.cornelia@mh-hannover.de
    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 Nulojix R
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameNulojix R
    D.3.2Product code 013116-D922
    D.3.4Pharmaceutical form Concentrate and diluent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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.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) Yes
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Cyclosporine
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameCyclosporine
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Kidney transplantation
    E.1.1.1Medical condition in easily understood language
    Trial exploring biomarkers of the immune system under de novo therapy with Belatacept vs. Cyclosporine after kidney transplantation
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10062016
    E.1.2Term Immunosuppression
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To explore a number of biomarkers from plasma, serum and renal tissue to describe the impact of different strategies for immunosuppression (Belatacept, Cyclosporine) on the immune-system that may explain differences in long-term outcome.
    E.2.2Secondary objectives of the trial
    The main secondary objective is to evaluate the diagnostic accuracy of various biomarkers (FACs panel, chemokines and cytokines) regarding the relevancy of an acute rejection episode with lower tendency to relapse and without relevant deterioration of renal function in the follow up and having regard to the randomly assigned immunosuppression.
    Renal function of the graft was favorable by a delta eGFR of 10 ml/min after 36 months even in a trial with marginal kidney donations as compared to renal transplant recipients under Cyclosporine (Benefit extended trial). Using markers of kidney toxicity in plasma, renal tissue and urine, we will describe whether this effect was due to a lower kidney toxicity of the drug as compared to Cyclosporine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients scheduled to receive a single-organ renal transplant, 18 to 65 years old at the day of inclusion.
    2. Transplant from a living or deceased donor aged under 65 years.
    3. Patients must have IgG-detectable positive Epstein-Barr virus serostatus.
    4. Patient must have signed the written informed consent.
    5. Patients must have a current or historic panel reactive antibody ≤30% (according to Lymphocytotoxicity-Test. The antibody screening is back followed until patients` acceptance as KTRs on the waiting list).
    6. Kidney donors must have a serum creatinine ≤ 1.5 mg/dl or 130 µmol/l.
    7. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant must have a negative pregnancy test using serum performed immediately before tx.
    8. Female patients must meet at least one of the following criteria:
    • For female patients ≥ 50 years of age at the day of inclusion: Menopause since at least 1 year.
    • For female patients < 50 years of age at the day of inclusion: Menopause since at least 1 year and serum FSH level > 40 mIU/mL.
    • 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral ovariectomy with or without hysterectomy.
    • Correct use of an effective method of birth control (locally acting hormonal contraceptives as vaginal products, skin patches, implanted or injectable products, mechanical products such as intrauterine devices or barrier methods as diaphragm, condoms, spermicides) during the study and until a minimum of 8 weeks after the last administration of investigational medicinal product. Oral hormonal contraceptives are not acceptable.
    • General sexual abstinence during the study and until a minimum of 8 weeks after the last administration of investigational medicinal product.
    • Having only female sexual partners.
    • Relationships with only sterile male partners
    9. Procreative male subjects should be advised to avoid unprotected sex throughout the study and until sperm produced during the period of drug exposure has been cleared (10 weeks).
    E.4Principal exclusion criteria
    1. History of lymphoproliferative disease.
    2. Patients with a proven or suspected history for tuberculosis who have not been previously treated for latent infections.
    3. Patients with other transplanted organs (heart, liver, pancreas) or with a history of bone marrow transplantation.
    4. Patients with previous renal graft.
    5. Patients with a malignant disease.
    6. Patients with an infectious hepatitis B or C or a positive HIV status.
    7. Patients unable to give their written consent (e. g. stroke patients or those with severe dementia or mental disability).
    8. Pregnant or lactating females.
    9. Current participation in any other clinical trial and/or participation in another clinical trial within 30 days before the study begin.
    10. Patients that are in a physical state that, in the opinion of the investigator, might interfere with the objectives of the study or pose additional risk to the patients due to participation in the study (e. g. patients with an elevated risk for bleeding* after kidney biopsy, patients with an immunological disease predisposing for rejection); *Hypocoagulability: thrombocytes < 100.000 /µl, Quick test < 70 % or INR < 2.0.
    11. Patients with a severe cachexia (BMI < 16).
    12. Patients with a history of allergy or drug reaction against the investigational medicinal products.
    13. Patients receiving an ABO-incompatible kidney donation from a living donor.
    14. Patients being pre-sensitized for donor specific antibodies before kidney transplantation using special lymphocyte depleting immunosuppressive protocols.
    E.5 End points
    E.5.1Primary end point(s)
    not applicable
    E.5.1.1Timepoint(s) of evaluation of this end point
    not applicable
    E.5.2Secondary end point(s)
    not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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
    The trial is monitored by a committee independent by the investigators.
    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 months30
    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: 70
    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 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 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)
    All patients will be continued on the local standard of care for this disease. Belatacept therapy as well as cyclosporine therapy will be continued.
    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 Decision2012-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-06-06
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