EUCTR2012-005652-42-DE进行中（未招募）不适用
Biomarkers Of The Humoral Immune Response After Conversion To Belatacept In Comparison To Conventional Immunosuppressive Therapy In Renal Transplant Patients
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •a.Renal transplant recipients, whose received renal allograft at least 3 months prior to inclusion
- •b.Patients on a CNI- or mTORi-based therapy for more than 3 months, who have signs of CNI- or mTORi related toxicity or intolerance and are converted due to clinical indication to a CNI- and mTORi-free immunosuppression with Belatacept
- •c.Patients with acceptable renal function and a serum creatinine =4 mg/dl.
- •d.Patient must have received primary or secondary renal allograft from a deceased donor or living donor from a compatible (A, B, AB or O) blood type
- •e.Patients with low to standard immunological risk, who had a PRA <30% before transplantation
- •f.Patients with concomitant immunosuppression with MPA (=1g/d MMF or =720 mg/d EC-MPS)
- •g.Age >18 years
- •h.Women of childbearing potential (WOCBP) must be using two adequate methods of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drug to minimize the risk of pregnancy.
- •i.WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal. Post-menopause is defined as:
- •j.Amenorrhea that has lasted for ? 12 consecutive months without another cause, or
- •k.For women with irregular menstrual periods who are taking hormone replacement therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of greater than 35 mIU/mL.
- •l.Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or who are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential.
- •m.WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of the investigational product.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •a.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 dose of study drug.
- •b.Women who are pregnant or breastfeeding.
- •c.Women with a positive pregnancy test.
- •d.Sexually active fertile men not using effective birth control if their partners are WOCBP.
- •e.Multi-organ recipients (solid organ or bone marrow)
- •f.Patients who suffered from severe rejection (= Banff II acute rejection), recurrent acute rejection, or steroid resistant rejection within 6 months of enrolment in this study.
- •g.Patient with malignancies with the exception of local, noninvasive, fully excised: cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma
- •h.Patients, who – according to the investigator – require for medical reasons continued therapy with CNI or mTORi
- •i.Subjects who have a negative or unclear serology concerning Epstein –Barr-Virus (EBV)
- •j.Treatment with any investigational drug within 3 months preceding the study
- •k.Prisoners, or subjects who are involuntarily incarcerated.
- •l.Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
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