EUCTR2004-002974-48-DE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-EXT
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
- 600
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 first-time recipient of a deceased donor kidney transplant;
- •3) The donor and/or donor kidney meet at least 1 of the following extended criteria
- •for organ donation:
- •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 (subjects should not be randomized if actual CIT
- •is < 20 hours)
- •d) Donor with cardiac death (non-heart beating donor)
- •4) Men and women, ages 18 and older, inclusive
- •5) 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.
- •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 IM103027 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 (ie, identical twins);
- •5) Donor age < 10 years;
- •6) 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
- •If a subject has ESRD of unknown etiology and/or has no histologically-confirmed
- •diagnosis, the subject may be enrolled into the study as long as there are no clinical signs or symptoms consistent with the clinical diagnosis of primary focal segmental
- •glomerulosclerosis, Type I or II membranoproliferative glomerulonephritis, or HUS, as
- •deemed by the investigator.
- •7) Subjects with current PRA >= 30%;
- •8) Subjects with a positive T-cell lymphocytotoxic crossmatch;
- •9) Subjects with any prior solid organ transplant (including kidney);
- •10) Subjects receiving a concurrent solid organ (heart, liver, pancreas) or cell (islet, bone marrow, stem cell) transplant 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;
- •11) Subjects receiving paired kidneys from the extended criteria donor (dual kidney
- •transplant);
- •12) Subjects who are hepatitis C antibody-positive or polymerase chain reaction
- •(PCR)-positive for hepatitis C;
- •13) Subjects who are hepatitis B surface antigen-positive or PCR-positive for hepatitis B;
- •14) Subjects with known human immunodeficiency virus (HIV) infection;
- •15) Subjects with active tuberculosis (TB) requiring treatment within the previous 3 years or any subject who previously required triple (or more) combination therapy for TB. Subjects with a known positive purified protein derivative (PPD) will not be eligible for the study unless they completed treatment for latent TB and have a negative chest x-ray at the time of enrollment. PPD testing done within the last 12 months is acceptable as long as there is documentation of the results. Subjects without a PPD in the last 12 months who have a previous negative result may be enrolled if they also have a negative chest x-ray at enrollment, no symptoms indicative of TB, no known TB contacts, not currently residing in, recently traveled to, or previously immigrated from an area endemic for TB. A PPD response that is >= 10 mm induration or a Heaf score of > 1 in non-Bacille Calmette-Guérin (non-BCG) immunized subjects or > 2 in BCG immunized subjects should be considered a positive test. More conservative criteria may be applied according to the published guidelines and/or local standards endorsed by the medical society;
- •16) Subjects with any active infection or other contraindication that would normally
- •exclude transplantation;
- •17) Subjects whose life expectancy is severely limited by disease state or other
- •underlying medical condition;
- •18) Subjects with a history of cancer (other than non-melanoma skin cell cancers cured by local resection) within the last 5 years;
- •19) 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 follow-up;
- •20) Subjects with active peptic ulcer disease,
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