EUCTR2004-003635-31-GB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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 738
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
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/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 human
- •immunodeficiency virus (HIV) infection
- •17) Subjects at risk for tuberculosis (TB). Specifically, subjects who:
- •a) Have current clinical, radiographic or laboratory evidence of active or latent
- •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
研究者
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