EUCTR2004-003635-31-PT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 - BENEFIT
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
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.
- •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 (ie, identical twins)
- •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
- •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 known hepatitis C antibody-positive or polymerase chain
- •reaction (PCR)-positive for hepatitis C.
- •15) Subjects who are known hepatitis B surface antigen-positive or PCR-positive for
- •hepatitis B.
- •16) Subjects with known human immunodeficiency virus (HIV) infection.
- •17) Subjects with active tuberculosis (TB) requiring treatment within the previous 3
- •years or any subject who previously required triple (or more) combination therapy
- •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:
- 另有 8 项未显示
研究者
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