A Single Site, Placebo Controlled, Double Blind Randomised Clinical Trial Evaluating the Effectiveness of Metformin to Prevent Post-transplant Diabetes in a Cohort of Patients Undergoing Renal Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Diagnosis of post-transplant diabetes
研究概览
简要总结
PrOphylaxis With mEtformin to pREvent PTDM: a single site, placebo controlled, double blind randomised clinical trial evaluating the effectiveness of metformin to prevent post-transplant diabetes in a cohort of patients undergoing renal transplantation.
详细描述
Renal transplantation is the optimal form of renal-replacement therapy in end-stage kidney disease. However, up to 30% of new renal transplants develop post-transplant diabetes mellitus (PTDM). The development of PTDM is associated with adverse graft and patient survival outcomes and represents an increased financial burden. There is an urgent clinical need to discover therapies which could decrease the risk of developing PTDM. Metformin offers a safe and cheap therapeutic option which has been demonstrated to reduce the incidence of type 2 diabetes in a high-risk non-transplant patient group. The investigators propose to study its safety and efficacy in preventing the development of PTDM.
POWERED is a single site, placebo-controlled, double- blind randomised clinical trial of metformin in patients without pre-existing diabetes mellitus who have received a new renal transplant. Eligible, consented patients are randomised to a 3 month course of either active drug or placebo within 10 days post-transplant. All patients will receive the usual standard of care for transplant patients. Clinical and laboratory data will be collected and assessed at baseline and throughout their participation in the study. The primary endpoint is the development of PTDM as defined by a positive oral glucose tolerance test (OGTT). Secondary endpoints include graft outcomes, pancreatic b-cell function and safety endpoints. The study began recruitment in January 2019 and plans to enrol 60 patients. There are no interim analyses planned.
Ethical approval was obtained from the London - Brighton and Sussex Ethics Committee (REC 18/LO/0958) prior to commencing the study. All study-related data will be used by the Sponsor in accordance with local data protection law. Results of the trial will be submitted for publication in a peer-reviewed journal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Both the patient and the study team will be blinded to the treatment intervention. The clinical team will also be blinded.
Pharmacy staff who dispense the IMP will not be blinded, nor will Sponsor Office staff responsible for reporting unblinded SUSAR reports to the MHRA.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (male or female) undergoing renal transplantation under the care of the Barts Health NHS Trust Renal Department
- •Aged 18-75 inclusively
- •Willing to comply with study schedule
排除标准
- •History of Type 1 or type 2 diabetes
- •Clinically significant history of abnormal physical and/or mental health as judged by the investigator other than conditions related to chronic kidney disease
- •Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug
- •Subject with a known hypersensitivity or contraindication to Tacrolimus
- •Subject with a known hypersensitivity or contraindication to Metformin
- •Pregnant or breast feeding
研究组 & 干预措施
Metformin
metformin 500mg OD
干预措施: Metformin (Drug)
Placebo
placebo 500mg OD
干预措施: Placebo (Drug)
结局指标
主要结局
Diagnosis of post-transplant diabetes
时间窗: 12 months post-renal transplant
Positive 2 hour oral glucose tolerance test (i.e. 2 hour sugar \>11.1 mol/L)
次要结局
- impaired glucose tolerance(12 months)
- HbA1c(12 months)
- Pancreatic beta cell function(12 months)
- incidence of treatment emergent adverse events(12 months)
- patient and graft survival(12 months)
- rejection(12 months)
- eGFR(12 months)
- diagnosis of PTDM in OGTT screen fails(12 months)