CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in kidney function as measured by eGFR
研究概览
简要总结
CREST-KT is a single-center, double-blinded, randomized trial of empagliflozin therapy in 72 kidney transplant recipients with (n=36) and without type 2 diabetes (n=36). After evenly dividing patients by type 2 diabetes diagnosis, patients will be randomized 2:1 to empagliflozin 10mg versus placebo.
详细描述
A screening visit will occur at which time an informed consent will be obtained, and eligibility determined. Women of childbearing potential will have a serum pregnancy test performed. This will be followed by a baseline visit. A renal biopsy and a 3D echocardiogram will be performed. At the next visit randomization will be performed and the subjects will receive their study medication, either empagliflozin or a placebo. Following the randomization visit the subject will return every 3 months (visits 2-7) for a total of 6 visits spanning 18 months. At each visit vital signs and weight will be taken. Other procedures include labs drawn for hematology, basic chemistry, coagulation, Glycated hemoglobin and serum insulin. A 3 D echocardiogram is repeated on Visits 4 and 6. A renal biopsy is repeated on Visit 3.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Equal to or greater than 12 months and up tp 60 months post kidney transplant
- •Estimated glomerular filtration rate (eGFR) equal to or greater than 30ml/min/1.73m squared at screening
- •Standard immunosuppression, including calcineurin inhibitor, Mycophenolate Mofetil or Sodium and a glucocorticoid
- •Able to provide written consent -
排除标准
- •Type I diabetes
- •Any other solid organ transplant
- •Hemoglobin A1c greater than 12 %
- •SGLT2i use at the time of enrollment
- •Prior SGLT2i allergy or intolerance
- •Pregnant or nursing at the time of enrollment
- •History of antibody medicated rejection (AMR) or a Banff score greater than 2B for acute cellular rejection (ACR)
- •Active anticoagulant use other than aspirin 81 mg for primary prevention of cardiovascular disease
- •Known positive donor-specific antibodies prior to enrollment
- •Uncircumcised men
- •Greater than 2 urinary tract infections (UTI) over the 12 months prior to enrollment
- •Any genital infections over the 12 months prior to enrollment -
研究组 & 干预措施
Arm I: With Type II Diabetes
Kidney Transplant recipient with Type II diabetes, randomized to either Empagliflozin or a placebo.
干预措施: Empagliflozin10Mg Tab (Drug)
Arm I: With Type II Diabetes
Kidney Transplant recipient with Type II diabetes, randomized to either Empagliflozin or a placebo.
干预措施: Placebo (Drug)
Arm 2: Without Diabetes
Kidney Transplant recipient without Type II diabetes, randomized to either Empagliflozin or a placebo
干预措施: Empagliflozin10Mg Tab (Drug)
Arm 2: Without Diabetes
Kidney Transplant recipient without Type II diabetes, randomized to either Empagliflozin or a placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in kidney function as measured by eGFR
时间窗: Baseline, 6 months, 9 months, 12 months and 18 months
eGFR will be measured by blood test
Change in fasting blood sugar
时间窗: Baseline, month 6 and month 18
Fasting Blood sugar will be determined lab values
Number of Genital infections
时间窗: up to 18 months
Data to be gathered from chart review and patient report
Change in kidney function as measured by albuminuria
时间窗: Baseline, 6 months, 9 months, 12 months and 18 months
Albuminuria will be measured by urine Albumin/Creatinine Ratio
Change in blood insulin level
时间窗: Baseline, month 6 and month 18
Blood insulin level will be determined lab values
Change in cardiac structure
时间窗: Baseline, month 9 and month15
Cardiac structure as measured by the 3D echocardiogram
Number of Urinary Tract infections
时间窗: up to 18 months
Data to be gathered from chart review and patient report
次要结局
- Changes in Hemoglobin A1C as measured by blood work(Baseline, Months 3,6,9,12,15 and 18)
- Change in kidney biopsy as measured by percentage of interstitial fibrosis(Baseline and 6 months)