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Clinical trials for Belatacept

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    15 result(s) found for: Belatacept. Displaying page 1 of 1.
    EudraCT Number: 2004-003635-31 Sponsor Protocol Number: IM103-008 Start Date*: 2005-12-12
    Sponsor Name:Bristol Myers Squibb International Corporation
    Full Title: Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (BENEFIT). Revised Protocol 05 incorporating Protocol Amendments 13 (dated 10-Feb-2011)
    Medical condition: TRANSPLANTATION,NOS
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) BE (Completed) GB (Completed) CZ (Completed) IT (Completed) DE (Completed) ES (Completed) SE (Completed) HU (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2004-002974-48 Sponsor Protocol Number: IM103-027 Start Date*: 2005-11-17
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial - EXTended Criteria Donors (BENEFIT-EXT). Revised Protocol Number 03 incorporating Administrative Lett...
    Medical condition: TRANSPLANTATION, NOS
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) AT (Completed) BE (Completed) SE (Completed) DE (Completed) CZ (Completed) IT (Completed) ES (Completed) PT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-003169-16 Sponsor Protocol Number: BMS55230 Start Date*: 2013-05-06
    Sponsor Name:Erasmus MC, University Medical Center Rotterdam
    Full Title: Immune monitoring to characterize T-cell responses of kidney transplant patients during co-stimulation blockade by belatacept
    Medical condition: Kidney transplantation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-005238-11 Sponsor Protocol Number: IM103-010 Start Date*: 2007-01-29
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Belatacept Conversion Trial in Renal Transplantation
    Medical condition: Subjects who received a kidney transplant
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) BE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-000237-12 Sponsor Protocol Number: IM103-402 Start Date*: 2021-05-04
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Prospective, Open-label, Multicenter, Randomized Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Renal Allograft Recipients Aged 12 to Less Than 18 Years of Age to a...
    Medical condition: Adolescent Renal Allografts
    Disease: Version SOC Term Classification Code Term Level
    21.0 10042613 - Surgical and medical procedures 10038533 Renal transplant PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) FR (Trial now transitioned) NL (Trial now transitioned) BE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-001178-20 Sponsor Protocol Number: IM103-307,SMR-2729 Start Date*: 2013-10-29
    Sponsor Name:Uppsala University Hospital, MHT, Department of Nephrology
    Full Title: Cardiovascular (CV) risk prediction and CV biomarkers in renal transplant recipients treated with belatacept compared to calcineurin inhibitors (CNI). Open randomized 12 month study.
    Medical condition: Prophylaxis of graft rejection in adults who have received a renal transplant
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004865 10050436 Prophylaxis against renal transplant rejection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2007-002125-68 Sponsor Protocol Number: IM103-045 Start Date*: 2007-11-23
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Evaluation of Belatacept as First-line Immunosuppression in De Novo Liver Transplant Recipients Revised Protocol Number 04, incorporating Amendments 02, 03, 04 and 05 (version 10.0 dated 20-Nov-0...
    Medical condition: First time recipient of a deceased donor liver transplant
    Disease: Version SOC Term Classification Code Term Level
    9.1 10024714 Liver transplant LLT
    9.1 10062016 Immunosuppression LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended) DE (Prematurely Ended) FR (Completed) ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-003114-17 Sponsor Protocol Number: IM103-034 Start Date*: 2007-09-13
    Sponsor Name:BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
    Full Title: A randomized,open-label,multicenter, parallel-group study of belatacept-based corticosteroid-free regimens in renal transplant
    Medical condition: Subjects receiving a kidney transplant from a living donor or a deceased donor
    Disease: Version SOC Term Classification Code Term Level
    9.1 10038533 Renal transplant LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2011-005257-31 Sponsor Protocol Number: IM103-144 Start Date*: 2014-04-28
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 2 Multi-Center, Randomized Conversion Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belatacept Administered to Pediatric Subjects with a Stable Renal Transplant Revised...
    Medical condition: Kidney Transplant
    Disease: Version SOC Term Classification Code Term Level
    21.0 10042613 - Surgical and medical procedures 10038533 Renal transplant PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-001314-42 Sponsor Protocol Number: IM103116 Start Date*: 2013-09-11
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix® (belatacept)-based Immunosuppression
    Medical condition: Maintenance of renal transplant recipients
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10023439 Kidney transplant rejection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) AT (Completed) DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2013-002090-21 Sponsor Protocol Number: IM103177 Start Date*: 2016-02-02
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Evaluation of Acute Rejection Rates in de novo Renal Transplant Recipients Following Thymoglobulin Induction, CNI-free, Nulojix (belatacept) -based Immunosuppression
    Medical condition: Maintenance of renal transplant recipients.
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021428 - Immune system disorders 10023439 Kidney transplant rejection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2011-006162-40 Sponsor Protocol Number: NODAT-BELATAC Start Date*: 2013-05-28
    Sponsor Name:Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
    Full Title: NEW-ONSET DIABETES MELLITUS AFTER RENAL TRANSPLANTATION. A MULTICENTRE, PROSPECTIVE, RANDOMIZED, OPEN STUDY TO EVALUATE BELATACEPT-BASED VERSUS TACROLIMUS-BASED IMMUNOSUPPRESSION
    Medical condition: Adult kidney transplant recipients older than 45 years old with risk of developing prediabetes states after renal transplantation (PREDAT) and diabetes mellitus after renal transplantation (NODAT)
    Disease: Version SOC Term Classification Code Term Level
    15.1 10014698 - Endocrine disorders 10018424 Glucose metabolism disorders (incl diabetes mellitus) HLGT
    15.1 100000004865 10023438 Kidney transplant LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-001352-19 Sponsor Protocol Number: 20120309-01 Start Date*: 2012-10-15
    Sponsor Name:Medizinische Hochschule Hannover
    Full Title: BE-RELACs-Trial: Biomarkers Explaining RELevance of ACute Rejections
    Medical condition: Kidney transplantation
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021428 - Immune system disorders 10062016 Immunosuppression PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-005652-42 Sponsor Protocol Number: IM103-319 Start Date*: 2013-09-30
    Sponsor Name:Charité, Universitätsmedizin Berlin
    Full Title: Biomarkers Of The Humoral Immune Response After Conversion To Belatacept In Comparison To Conventional Immunosuppressive Therapy In Renal Transplant Patients
    Medical condition: Patients after renal transplantation with signs of drug intolerance to their immunsuppressive therapy are considered to be converted to Nulojix
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10038533 Renal transplant PT
    14.1 10042613 - Surgical and medical procedures 10054980 Immunosuppressant drug therapy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-004144-28 Sponsor Protocol Number: CCTU0307 Start Date*: 2020-10-23
    Sponsor Name:Cambridge university Hosptials NHS Foundation Trust and University of Cambridge
    Full Title: PROphylaxis for paTiEnts at risk of COVID-19 infecTion
    Medical condition:
    Disease:
    Population Age: Gender:
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
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