Impact of the Absence of Steroids on the Evolution of Renal Function and on the Progression of Graft Fibrosis, Quantified by Numerical Method, in Patients With Renal Transplant
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 8
- 主要终点
- Percentage of fibrosis of the graft
研究概览
简要总结
The main objective of this study is to demonstrate that the absence of post-transplantation corticosteroids does not induce a larger increase of renal graft fibrosis (by numerical reading) on biopsy at one year post-transplantation than immunosuppressive treatment strategy that includes standard oral corticosteroids.The secondary objectives of the study consist to compare on various parameters (fibrosis progression, renal function, dialysis, ratio of proteinuria/creatinuria, acute rejection, donor-specific antibody, graft survival, clinical and biological tolerance) therapy with no corticosteroids post-transplantation in comparison to standard immunosuppressive treatment strategies including oral corticosteroids. Secondary objectives of the study consist also to compare the two techniques for assessing fibrosis by numerical reading and by centralized blinded reading of the treatment group (by 2 anatomical pathologists).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to70 years,
- •Accepting to give, after information, their signed informed consent form,
- •Not having difficulties to understand and communicate with the investigator and his representatives,
- •Requiring a renal transplant [first or second transplant (except if the first renal transplant was lost due to rejection)],
- •Patient insured.
- •Inclusion criteria :
- •Transplant of a kidney from a deceased or living donor (non HLA-identical) with ABO compatibility,
- •Existence of a renal graft biopsy (or of one of the grafts, if bi-renal transplant) before transplantation,
- •Percentage of positive responses to PRA (panel reactive antibodies), measured by the Luminex® less than 20% of IgG anti-T or absence of positive DSA by Luminex regardless of the mean fluorescence (MFI) within the last 6 months,
- •Negative cross match T in cytotoxicity and / or flow cytometry,
- •Negative pregnancy test for patients of childbearing age, and consent to use an effective contraception throughout the study and 6 weeks after the end of the study.
排除标准
- •First renal transplant lost due to rejection,
- •Combined transplantation,
- •Previous history of transplantation other than kidney,
- •Non beating donor heart,
- •Presence of positive DSA by Luminex® regardless of the average of fluorescence (MFI),
- •Patients receiving corticosteroids at the time of transplantation,
- •Necessity to continue administration of systemic immunosuppressive treatment before transplantation,
- •Infections or severe diarrhea, vomiting, upper gastrointestinal tract malabsorption or active peptic ulcers, concomitant, significant and uncontrolled,
- •Subject or HIV positive donor,
- •Replicating viral hepatitis at the time of randomization,
- •Known allergy or intolerance to tacrolimus, macrolide, corticosteroids, mycophenolate mofetil or to any of the excipients,
- •Diagnosis of de novo malignancy prior to transplantation, with the exception of treated effectively basal cell or squamous cell carcinomas of the skin,- Current participation at another clinical study,
- •All clinical condition that the investigator considers incompatible with the conduct of the study in acceptable security conditions,
- •Inability of patient to comply with study procedures,
- •Pregnant or breast-feeding women,
- •Person placed under guardianship, under protection of law.
研究组 & 干预措施
Absence of corticotherapy post-transplantation
All patients included in this arm will receive the usual treatment strategy (including Advagraf, Cellcept ou Myfortic and Simulect) without corticotherapy post-transplantation.
干预措施: Absence of corticotherapy post-transplantation (Other)
Corticotherapy post-transplantation
All patients included in this arm will receive the usual treatment strategy (including Advagraf, Cellcept ou Myfortic and Simulect) with corticotherapy post-transplantation : prednisone or prednisolone orally for at least one year post-transplantation.
干预措施: Corticotherapy post-transplantation (Drug)
结局指标
主要结局
Percentage of fibrosis of the graft
时间窗: One year post-transplantation
Evolution of the percentage of fibrosis of the graft during the first year after transplantation (pre-transplant biopsy versus biopsy at one year), by numerical reading of fibrosis by image analysis.
次要结局
- Average glomerular filtration rate(One year post-transplantation)
- Percentage of fibrosis of the graft(One year post-transplantation)
- Percentage of fibrosis of the graft.(One year post-transplantation)
- Dialysis session(One year post-transplantation)
- Ratio of proteinuria/creatinuria(One year post-transplantation)
- Episode of acute rejection(One year post-transplantation)
- Diagnosis of DSA(One year post-transplantation)
- Percentage of graft failure(One year post-transplantation)
- Difference between numerical reading of fibrosis and evaluation by anatomical pathologists(One year post-transplantation)
- Number of adverse events(One year post-transplantation)