跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/EUCTR2004-003635-31-AT
EUCTR2004-003635-31-AT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) - BENEFIT

Bristol Myers Squibb International Corporation0 个研究点目标入组 726 人开始时间: 2005年11月7日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
相关药物

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

研究者

相似试验

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 - BENEFITTRANSPLANTATION,NOS
EUCTR2004-003635-31-BEBristol Myers Squibb International Corporation726
进行中（未招募）
不适用
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial - EXTended Criteria Donors (BENEFIT-EXT). Revised Protocol Number 08 incorporating Protocol Amendment 11+ Protocol Amendment 04 - Site Specific. - BENEFIT-EXTTRANSPLANTATION, NOS
EUCTR2004-002974-48-ATBristol-Myers Squibb International Corporation600
进行中（未招募）
不适用
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (BENEFIT).And Pharmacogenetcis Blood Sample Amendment 01 - Site Specific - 04AUG2005 - BENEFITTRANSPLANTATION,NOS
EUCTR2004-003635-31-PTBristol Myers Squibb International Corporation726
进行中（未招募）
1 期
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (BENEFIT). + Pharmacogenetcis 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 Revised Protocol 01 incorporating Amendment 06 - BENEFIT
EUCTR2004-003635-31-GBBristol Myers Squibb International Corporation738
进行中（未招募）
1 期
Belatacept Evaluation of Nephroprotection and Efficacy as First-lineImmunosuppression (BENEFIT)
EUCTR2004-003635-31-SEBristol Myers Squibb International Corporation726