EUCTR2004-003635-31-IT进行中（未招募）不适用
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (BENEFIT). Revised Protocol 04 incorporating Protocol Amendments 12 (dated 18-Oct-10), and Administrative Letters 09 and 10 + Pharmacogenetics 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 transplantwith 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 pregnancythroughout the study and for up to 8 weeks after the study in such a manner thatthe risk of pregnancy is minimized. WOCBP must have a negative serum pregnancy test (minimum sensitivity 25 IU/L orequivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to thestart 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: 0
- •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 pairs5) Donor age < 10 years6) Subjects receiving and extended criteria donor organ as defined by:a) Donor age `?¥ 60 yearsORb) 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/dLORc) Anticipated CIT `?¥ 24 hoursORd) Donor with cardiac death (non-heart beating donor)7) Subjects with underlying renal disease of:a) Primary focal segmental glomerulosclerosisb) Type I or II membranoproliferative glomerulonephritis.c) Hemolytic uremic syndrome (HUS) / thrombotic thrombocytopenic purpura syndrome8) 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 C15) Subjects who are/whose allograft donor was known hepatitis B surface antigen-positive or PCR-positive for hepatitis B16) Subjects and recipients of a graft from a donor with known HIV infection17) Subjects at risk for tuberculosis (TB). Specifically, subjects who:a) Have current clinical, radiographic or laboratory evidence of active or latent TBb) 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)Chemistry:`?' Bilirubin >1.5 x upper limit of normal range (ULN); Subjects who have Gilbert s syndrome and have a normal direct bilirubin are permitted`?' Aspartate aminotrans
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