NCT01292525终止3 期
Prospective, Multicenter, Randomized, Double-blind, Controlled Parallel Group Study Designed to Assess the Risk-benefit Balance of the Gradual Withdrawal of a Calcineurin Inhibitor (Tacrolimus) in Renal Transplant Patients Over 4 Years and Clinically Selected
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Renal function
研究概览
简要总结
The main objective of this study is to demonstrate the benefit of the withdrawal of Tacrolimus (Prograf®) on renal function in patients one year after the end of the weaning period. The secondary objectives will focus on assessing the risks and consequences of withdrawal of Tacrolimus (Prograf®).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Glomerular Filtration Rate (GFR), defined by the dosage of cystatin C ≥ 40 ml/min/1, 73m²,
- •Proteinuria ≤ 0,5 g / day,
- •Patient with serum levels of Tacrolimus between 5 to 10 ng / ml on average during the last 6 months (inclusive). It is accepted that 25% of the assays performed during the last 6 months, serum levels of tacrolimus are outside the limits mentioned above (5-10 ng / ml). They must nevertheless be between 3.5 to 12.5 ng / ml (inclusive).
- •Patient with serum levels of MPA (Cellcept® and Myfortic®) higher ≥ 30 mg / ml,
- •No anti-HLA antibodies at the time of inclusion, verified using highly sensitive techniques (Luminex HD),
- •Lack of histological evidence of cellular or humoral acute or chronic or subclinical rejection on renal graft according to the latest classification of Banff 2009.
排除标准
- •Patients under age 18 or over 80 years,
- •Transplanted from less than 4 years and over 10 years,
- •Patients re-transplanted,
- •Transplantation of several organs,
- •Patient not treated with tacrolimus as maintenance therapy,
- •Serum levels of Tacrolimus patient <5 or >10 ng / ml,
- •Serum levels of MPA of the patient <30 mg / ml,
- •Patients treated with other immunosuppressive drugs that Tacrolimus (Prograf®), MPA (Cellcept® and Myfortic®) and steroids,
- •Patient not having a stable graft function at baseline (change in serum creatinine > 25% of the average of the year before inclusion in the study), with a GFR defined by the dosage of cystatin C <40 ml/min/1, 73m² at the time of inclusion,- Patients with proteinuria > 0.5 g at study entry,
- •Patient with HLA antibodies at study entry,
- •Patient non-compliant,
- •Presence of histological evidence of cellular or humoral acute or chronic or subclinical rejection on renal graft according to the latest classification of Banff 2009,
- •History of lymphoproliferative disorders,
- •Diagnosis of a malignancy within 5 years before enrollment,
- •Significantly abnormal hematologic data of a clinical standpoint, as determined by the investigator for hematocrit, hemoglobin, white blood cell count or platelets,
- •Data significantly abnormal blood biochemistry of a clinical standpoint, as determined by the investigator,
- •Abuse of significant drug or alcohol at the time of inclusion, determined by the investigator,
- •Patient positive for antibodies to hepatitis C or hepatitis B surface antigen of hepatitis B (HBsAg) or HIV infection,
- •Participation in a clinical study within 3 months,
- •Pregnancy, Breastfeeding.
研究组 & 干预措施
Tacrolimus
Active Comparator
干预措施: Tacrolimus (Drug)
Withdrawal of Tacrolimus
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Renal function
时间窗: one year after complete withdrawal of Tacrolimus
The primary endpoint will be the improvement of renal function one year after complete withdrawal of Tacrolimus (Prograf®) assessed by measuring the glomerular filtration rate (GFR) calculated by the dosage of cystatin C according to the equation Bricon. The DFG will be compared between times J-30 and J480 (1 year after the withdrawal).
次要结局
- Steroid-resistant rejection(One year after complete withdrawal)
- Graft survival(One year after complete withdrawal)
- Chronic rejection(One year after complete withdrawal)
- Renal function(one year after complete withdrawal)
- Acute rejection(one year after complete withdrawal)
- Cancer and infections(one year after complete withdrawal)
- Patients survival(One year after complete withdrawal)
- Anti-HLA antibodies(One year after complete withdrawal)
- Histological lesions of rejection(One year after complete withdrawal)
- Histological lesions of fibrosis(One year after complete withdrawal)
- Hypertension, hyperglycemia and hyperlipidemia(One year after complete withdrawal)
- Quality of life(One year after complete withdrawal)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant RecipientsKidney TransplantNCT03749356Chong Kun Dang Pharmaceutical141
终止
4 期
Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXRKidney TransplantationKidney Transplant RejectionNCT04773392University of Southern California20
已完成
4 期
Study to Assess the Safety and Efficacy of Tacrolimus (Prograf Capsule/Injection) and Methotrexate (MTX) Combination Therapy for Prevention of Graft Versus Host Disease (GVHD) in Patients Who Received Peripheral Hematopoietic Stem Cell Transplantation From a Sibling DonorGraft Versus Host DiseaseNCT02660684Astellas Pharma Korea, Inc.39
已完成
3 期
Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis PatientsUlcerative ColitisNCT00347048Astellas Pharma Inc62
终止
4 期
A Study to Evaluate the Efficacy and Safety of Tacrolimus With Steroid in Korean Lupus Nephritis PatientsLupus NephritisNCT01316133Astellas Pharma Korea, Inc.37