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    Summary
    EudraCT Number:2005-005238-11
    Sponsor's Protocol Code Number:IM103-010
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-19
    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 ConcernedFrance - ANSM
    A.2EudraCT number2005-005238-11
    A.3Full title of the trial
    Belatacept Conversion Trial in Renal Transplantation
    A.4.1Sponsor's protocol code numberIM103-010
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameBELATACEPT
    D.3.2Product code BMS-224818
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNBelatacept
    D.3.9.2Current sponsor codeBMS-224818
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeFusion protein
    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
    Subjects who received a kidney transplant
    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
    The primary objective is to assess the effects of a belatacept-based immunosuppressive regimen relative to a CNI-based immunosuppressive regimen on the change in calculated GFR from baseline to 12 months post-randomization.
    E.2.2Secondary objectives of the trial
    • Assess the incidence and severity of acute rejection (AR) at 6 and 12 months post-randomization
    • Assess the change in calculated glomerular filtration rate (GFR) from baseline to 6 months
    • Assess the incidence of discontinuation of study medication or dose alteration due to declining renal function at 6 and 12 months
    • Assess the incidence of death and graft loss at 6 and 12 months
    • Assess the change in serum creatinine (SCr) from baseline to 6 and 12 months
    • Assess the incidence of new onset diabetes at 6 and 12 months
    • Assess the incidence of human leukocyte antigen (HLA) antibodies at baseline (randomization) and at 6 and 12 months
    • Assess QoL at baseline (randomization) and at 6 and 12 months
    • Assess safety and tolerability
    • Overall safety and tolerability of a belatacept-based immunosuppressive regimen
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Comprehensive PK assessment will be performed under a separate sub-study protocol.
    The PK parameters related to this sub-study will be reported separately.
    Sparse PK samples will be collected from all belatacept-treated subjects in the main study at the following time points:
    • Pre-dose serum samples at Weeks 4, 24, and 52
    • One hour after start of infusion (ie, 30 minutes after infusion) at Week 20.
    Additionally, a blood sample for PK analysis should be obtained at any time a rejection episode is suspected. If a rejection is suspected at the time of an infusion, obtain the PK sample prior to belatacept infusion.
    E.3Principal inclusion criteria
    1) The subject is willing to provide signed written informed consent
    2) Subjects must be a recipient of a renal allograft from a living donor or a deceased donor at least 6 months, but not longer than 36 months, prior to randomization
    3) Subjects must be receiving a CNI-based (CsA [any formulation] or TAC) immunosuppressive regimen
    4) The dose of CNI must have been stable over the month prior to randomization
    a) For subjects receiving CsA, trough serum concentration at the time of enrollment must be 100-250 ng/mL (based on screening/baseline central laboratory results)
    b) For subjects receiving TAC, trough serum concentration at the time of enrollment must be 5-10 ng/mL (based on screening/baseline central laboratory results)
    5) Subjects must be receiving adjunctive background maintenance immunosuppression with MMF, MPA, SRL, or AZA
    a) Subjects receiving MMF must have received a minimum total daily dose of 1.5 g for the month prior to randomization (up to 3 missed doses are acceptable provided doses were not missed due to drug intolerance)
    b) Subjects receiving MPA must have received a minimum total daily dose of 1080 mg for the month prior to randomization (up to 3 missed doses are acceptable provided doses were not missed due to drug intolerance)
    c) Subjects receiving AZA must have received a minimum daily dose of 50 mg for the month prior to randomization (up to 3 missed doses are acceptable provided doses were not missed due to drug intolerance)
    d) Subjects receiving SRL must have a trough serum concentration at the time of enrollment of 5-15 ng/mL (based on screening/baseline central laboratory results)
    6) If subjects are receiving concomitant corticosteroids (steroid use is not required), the dose of corticosteroid must have been stable over the month prior to randomization with no anticipated dose alteration in the next 6 months
    7) Subjects must have a calculated GFR ≥ 35 and ≤ 75 mL/min/1.73 m2 (MDRD formula) at the time of enrollment (based on screening/baseline central laboratory results)
    8) Men and women, ages 18 years and older, inclusive
    9) WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the study in such a manner that the risk of pregnancy is minimized.
    E.4Principal exclusion criteria
    1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last infusion of study medication
    2) WOCBP using a prohibited contraceptive method
    3) Women who are pregnant or breastfeeding
    4) Women with a positive pregnancy test on enrollment or prior to study drug
    administration
    5) Subjects with underlying renal disease of:
    a) Primary focal segmental glomerulosclerosis
    b) Type I or II membranoproliferative glomerulonephritis
    c) Hemolytic uremic syndrome (HUS)/thrombotic thrombocytopenic purpura syndrome
    6) Subjects expected to undergo weaning of immunosuppressive therapy during the period of the study
    7) Subjects with a pre-transplant panel reactive antibodies (PRA) ≥ 50%
    8) Subjects with previous graft loss due to acute rejection (AR)
    9) Subjects whose SCr at enrollment is over 30% higher than 3 months (± 4 weeks) prior to randomization
    10) Subjects with an episode of AR in the last 3 months. Subjects who have had an episode of AR are required to have had clinical resolution for at least 3 months prior to randomization
    11) Subjects who have had a Banff 97 Grade IIA or greater AR (or equivalent), steroid-resistant AR or have received lymphocyte-depleting agents, plasmapheresis, or rituximab for the treatment of AR since transplantation of current allograft
    12) Subjects who have experienced more than 1 episode of rejection of the current allograft
    13) Subjects with a biopsy of the current allograft staining C4d positive. Neither a biopsy nor C4d staining is required for entry into the study
    14) Subjects who have experienced complications of anastomotic stenosis or stricture (vascular or ureteral)
    15) Subjects who had a positive T-cell or B-cell crossmatch
    16) Subjects who have documented BK virus (polyoma virus) nephropathy (biopsy is not required for enrollment)
    17) Subjects who have documented evidence of recurrence of the primary cause of end-stage renal disease (ESRD) in their current or in a past renal allograft
    18) Subjects with multiple solid organ (heart, liver, pancreas) or cell (islet, bone marrow, stem cell) transplants
    19) Subjects who received paired kidneys (dual or en bloc kidney transplants)
    20) Subjects who are known hepatitis C antibody-positive or PCR-positive for hepatitis C (neither hepatitis C antibody or PCR for hepatitis C testing is required for entry into the study)
    21) Subjects who are known hepatitis B surface antigen-positive or PCR-positive for
    hepatitis B (neither hepatitis B surface antigen or PCR for hepatitis B testing is required for entry into the study)
    22) Subjects with known HIV infection. HIV testing is not required for entry into the study
    23) Subjects with a chest radiograph (posterior-anterior and lateral views) consistent with an acute lung parenchymal process, malignancy, or active tuberculosis. Subjects must have a chest radiograph within 2 months prior to randomization
    24) Subjects with any significant infection

    Medical History and Concurrent Diseases
    25) Subjects whose life expectancy is severely limited by disease state or other underlying medical condition
    26) Subjects with a history of cancer (other than non-melanoma skin cell cancers cured by local resection) within the last 5 years
    27) Subjects with a history of substance abuse (drug or alcohol) within the past 5 years, or psychotic disorders that are not compatible with adequate study follow-up

    Physical and Laboratory Test Findings
    28) Subjects with laboratory values that meet the following criteria are to be excluded from the study:
    Urine Assay:
    • Proteinuria > 1,000 mg/day or
    • Urine protein creatinine ratio > 1
    Hematology:
    • Hemoglobin < 7 g/dL
    • Platelets < 80,000/mm3
    • White blood cell count < 3000/mm3 (3 x 109/L)
    Chemistry:
    • Bilirubin >1.5 x upper limit of normal range (ULN); Subjects who have Gilbert’s syndrome and have a normal direct bilirubin are permitted
    • Aspartate aminotransferase (AST) ≥ 2 x ULN
    • Alanine aminotransferase (ALT) ≥ 2 x ULN
    29) All women ≥ 40 years and women of any age who have first degree relatives with a history of breast carcinoma, or who have other risk factors of breast carcinoma, must have a screening mammogram, or provide results of a screening mammogram performed within 6 months of enrollment. Subjects with a mammogram that is suspicious for malignancy and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations will be excluded
    30) Subjects who have difficult i.v. access

    Prohibited Therapies and/or Medications
    31) Subjects who have used any investigational drug within 30 days prior to the Day 1 visit
    32) Subjects previously treated with belatacept

    Other Exclusion Criteria
    33) Prisoners or subjects who are compulsorily detained
    E.5 End points
    E.5.1Primary end point(s)
    Assess the change in calculated GFR (MDRD formula) from baseline to 12 months post-randomization.
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity Analyses; QoL; Biomarkers; Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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.8.3 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 EEA12
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 170
    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)
    The duration of the study is 12 months with a subsequent 8-week follow-up period for safety evaluations. If belatacept is not marketed at the end of the 12-month treatment period, subjects may be eligible for a long-term extension study. This will be detailed in a protocol amendment, and a separate informed consent will be required.
    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 Decision2007-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-07
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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