NCT05316038Unknown不适用
Study of the Impact of Belatacept Conversion on Metabolic and Infectious Complications in Kidney Transplant Recipients at Grenoble-Alpes University Hospital
University Hospital, Grenoble0 个研究点目标入组 100 人开始时间: 2022年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Oral glucose tolerance test results in kidney transplant patients on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 1 year
研究概览
简要总结
The BELASWITCH study is a prospective single-centre study including all kidney transplant patients for whom a conversion from Tacrolimus to Belatacept has been decided by the transplant clinicians of the Grenoble Alpes University Hospital.
Each patient will be included at the time of conversion (patients stable on Tacrolimus for at least 6 months) and will be their own control 1 year after conversion to Belatacept.
The study has two components:
- A "Metabolic" benefit arm: the investigators assume that conversion from Tacrolimus to Belatacept reduces the risk of diabetes by reducing the level of insulin resistance.
- An "Infectious" risk arm: measurement of the viral load of Torque Teno Virus to assess the state of immunosuppression of patients. In this sense, the investigators hypothesise that it could serve as a biomarker of immunodepression in this population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients who have had a kidney transplant more than 6 months ago.
- •Whose immunosuppression includes stable Tacrolimus (change in dose or dosage form allowed) for at least 3 months.
- •Therapeutic plan to change Tacrolimus-based immunosuppression to Belatacept
- •Having signed the consent of collection CRB04 - Nephrology Collection (last authorization number: AC-2019-3627) and the BELASWITCH protocol consent.
排除标准
- •Subjects under guardianship or deprived of liberty
- •Patients who object to the use of their data and/or samples in the research
- •Patients having received an immunosuppressive treatment different from the standard one (Tacrolimus, mycophenolate mofetil or Everolimus, corticosteroids)
- •ABO and/or HLA incompatible kidney transplantation
结局指标
主要结局
Oral glucose tolerance test results in kidney transplant patients on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 1 year
时间窗: 1 year
Torque TenoVirus replication (in copies/ml) in kidney transplant patients on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year.
时间窗: 1 year
次要结局
- Compare the performance of TorqueTenoVirus quantitative polymerase chain reaction in copies/ml performed on plasma and whole blood samples(3 months)
- Comparison of weight and height (combined to report BMI in kg/m^2) on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year(1 year)
- Comparison of LDL measurment in g/l on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year(1 year)
- Number of major cardiovascular events (stroke, coronary syndrome, hospitalization for cardiac decompensation, death from cardiovascular causes)(1 year)
- Correlatation of TorqueTenoVirus replication (in copies/ml) with immunosuppressant assays: Tacrolimus (µg/l) at M-1 and D0 and Belatacept (µg/l) at M3, M6 and M12(1 year)
- Trough Plasma Concentration of Belatacept(3 months)
- Comparison of HbA1c measurment in percentage on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year(1 year)
- Comparison of triglycerides measurment in g/l on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year(1 year)
- Correlation of TorqueTenoVirus replication in copies/ml with the occurrence of opportunistic infections (Cytomegalovirus, Epstein-Barr virus, BKVirus).(1 year)
- Correlation of TorqueTenoVirus in copies/ml and the risk of biopsy-proven renal transplant rejection up to M12 after conversion to Belatacept.(1 year)
- Area under the plasma concentration versus time curve (AUC) of Belatacept(3 months)
- Comparison of abdominal perimeter of kidney transplant recipients in centimeters on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year(1 year)
- Comparison of HDL measurment in g/l on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year(1 year)
- Comparison of blood pressure in mmHg on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year(1 year)
研究者
EssaiClinique_Belaswitch
Pincipal investigator
University Hospital, Grenoble
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