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临床试验/EUCTR2004-003635-31-BE
EUCTR2004-003635-31-BE进行中（未招募）不适用

Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (BENEFIT).Revised Protocol 05 incorporating Protocol Amendments 13 (dated 10-Feb-2011)+ Pharmacogenetics Blood Sample Amendment 01 Site Specific - 04-Aug-05+ Exploratory Research Substudy Amendment Number 2 - Site Specific - Selected Sites, version 1.0 dated 29-Jun-06 - BENEFIT

Bristol Myers Squibb International Corporation0 个研究点目标入组 726 人开始时间: 2005年12月5日最近更新:
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适应症
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
726
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •1) The subject is willing to provide signed written informed consent.
  • •2) The subject is a recipient of a living donor or deceased donor kidney transplant
  • •with an anticipated CIT < 24 hours.
  • •3) Men and women, ages 18 and older, inclusive.
  • •4) 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.
  • •WOCBP must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or
  • •equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to the
  • •start of study medication.
  • •It should be noted that according to the US product information for mycophenolate mofetil (CellCept®), two reliable forms of contraception must be used simultaneously unless abstinence is the chosen method.
  • •Inclusion criteria for participation in Protocol Amendment 09 - Long-Term Extension:
  • •6) Subjects must be willing to participate and provide signed, written informed consent for this long term extension phase.
  • •7) Subjects must have completed 3 years in the IM103008 study (through Month 36) and remained on study treatment (belatacept or cyclosporine)
  • •8) Subjects must be willing and able to continue therapy with MMF. If a subject is unable to tolerate therapeutic doses of MMF, another adjuvant agent may be substituted as described in Section 6.2.6.2.
  • •9) Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •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.
  • •2) Women who are pregnant or breastfeeding.
  • •3) Women with a positive pregnancy test on enrollment or prior to study drug administration.
  • •4) Genetically-identical donor recipient pairs
  • •5) Donor age < 10 years
  • •6) Subjects receiving and extended criteria donor organ as defined by:
  • •a) Donor age = 60 years
  • •b) Donor age 50 – 59 years and 1 of the following:
  • •(i) Cerebrovascular accident (CVA) + hypertension + SCr > 1.5 mg/dL OR
  • •(ii) CVA + hypertension OR
  • •(iii) CVA + SCr > 1.5 mg/dL OR
  • •(iv) Hypertension + SCr > 1.5 mg/dL
  • •c) Anticipated CIT = 24 hours
  • •d) Donor with cardiac death (non-heart beating donor)
  • •7) 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
  • •8) Subjects undergoing primary (first-time) transplant with a current PRA = 50%, or subjects undergoing retransplantation with a PRA = 30%.
  • •9) Subjects with previous graft loss due to acute rejection.
  • •10) Subjects with a positive T-cell lymphocytotoxic cross match.
  • •11) Subjects with prior non-renal solid organ transplant (subjects undergoing kidney retransplantation are eligible pending other study criteria being met), or subjects undergoing multi-organ transplants (eg, kidney-pancreas) or subjects deemed likely to have a second solid organ or cell transplant (eg, pancreas or islet transplant) in the next 3 years by the investigator.
  • •12) Subjects receiving a concurrent solid organ (heart, liver, pancreas) or cell (islet, bone marrow, stem cell) transplant.
  • •13) Subjects receiving paired kidneys (dual or en bloc kidney transplants).
  • •14) Subjects who are/whose allograft donor was known hepatitis C antibody-positive or polymerase chain reaction (PCR)-positive for hepatitis C
  • •15) Subjects who are/whose allograft donor was known hepatitis B surface antigen-positive or PCR-positive for hepatitis B
  • •16) Subjects and recipients of a graft from a donor with known HIV infection
  • •17) Subjects at risk for tuberculosis (TB). Specifically, subjects who:
  • •a) Have current clinical, radiographic or laboratory evidence of active or latent TB
  • •b) Have a history of active TB (see Protocol)
  • •c) In the opinion of the investigator, a risk of reactivation of TB that precludes the use of conventional immunosuppression.
  • •18) Subjects with any active infection or other contraindication that would normally exclude transplantation.
  • •19) Subjects whose life expectancy is severely limited by disease state or other underlying medical condition.
  • •20) Subjects with a history of cancer (other than non-melanoma skin cell cancers cured by local resection) within the last 5 years.
  • •21) 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 followup 22) Subjects with active peptic ulcer disease, chronic diarrhea, or gastrointestinal malabsorption.
  • •23) Subjects with laboratory values that meet the following criteria are to be excluded from the study:
  • •Hematology:
  • •- Hemoglobin < 7 g/dL
  • •- Platelets < 80,000/mm3
  • •- White blood cell (WBC) count < 3000/mm3 (3 x 109/L)
  • •- Bilirubin >1.5 x upper limit of normal range (ULN); Subjects who have Gilbert’s syndrome and have a normal direct bilirubin are perm

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