EUCTR2015-005346-58-DE进行中（未招募）1 期
Tacrolimus after rATG and infliximab induction immunosuppression (RIMINI)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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. Primary deceased-donor or living-donor kidney transplantation
- •2. Men and women (recipient) age >18 years and <70 years
- •3. Panel reactive antibody frequency/ calculated panel reactive antibody frequency (peak PRA/cPRA) <20%
- •4. Written informed consent
- •5. Diagnosis of end stage renal disease
- •6. Women of Childbearing Potential (WOCBP) must be using a highly effective method of contraception (Pearl-Index < 1) to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea = 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL]. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of clinical trial. Male participants with pregnant or non-pregnant WOCBP partner must use condoms.
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Previous transplantation
- •2. Combined kidney transplantation with other organ
- •3. Subjects receiving an allograft from a donor older than 65 years with elevated serum creatinine levels and/or treated diabetes.
- •4. Immunosuppressive therapy up to 6 months before transplantation
- •5. Planned induction therapy with depletion agents
- •6. EBV seronegativity
- •7. HIV positivity
- •8. Leukopenia < 3000 cells per microliter, thrombocytopenia < 100 000 cells per microliter
- •9. Biological therapy history with ATG, OKT3, anti TNF agents
- •10. Tuberculosis history
- •11. Cancer history (skin non-melanoma cancer excluded)
- •12. Anti HCV positivity, HBsAg positivity or HBV DNA positivity
- •13. Detectable donor specific antibodies (DSA) by solid phase assay (Luminex®)
- •14. Subjects with a known hypersensibility to any of the drugs used in this protocol
- •15. Subjects who have used any investigational drug within 30 days prior to enrolment in this clinical trial
- •16. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period, women who are pregnant or breastfeeding or women with a positive pregnancy test on enrolment
- •17. Subjects who are legally detained in an official institution
- •18. All contraindications against study medication (including auxiliary substances)
- •19. Interactions with study medication
- •20. Current treatment with one of the following substances: cyclosporine, tacrolimus, mycophenolate mofetil, azathioprine, rituximab, prednisone
- •21. Patients unwilling to consent to saving and propagation of pseudonymized medical data and/or biological samples for study reasons
- •22. Chronic heart failure (NYHA III, IV) at transplantation
- •23.Participation in other clinical trials (pharmaceutical trials)
- •24. persons dependent of the sponsor, investigator or investigative site
- •25. positive Quantiferon test (for TBC)
- •26. live vaccine treatment 30 days prior to enrolment in this clinical trial
研究者
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