CTIS2022-501068-16-00进行中（未招募）1 期
Insulin Resistance and Statin Treatment in Renal Transplant Recipients and Patients with Chronic Kidney Disease - INSTA
Aarhus University Hospital0 个研究点目标入组 30 人开始时间: 2022年7月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •STUDY 1: 1) Age 40-70 years; 2) BMI 20-30 kg/m2; 3) Renal transplantation > 6 months prior to inclusion; 4) Combination immunosuppressive treatment with mycophenolate, tacrolimus, and prednisolone; 5) eGFR > 29 ml/min; 6) Written, informed consent prior to study inclusion, STUDY 2: 1) Age 40-70 years; 2) BMI 20-30 kg/m2; 3) Chronic kidney disease stage 3 i.e., eGFR > 29 ml/min and < 60 ml/min; 4) Written, informed consent prior to study inclusion
排除标准
- •STUDY 1: 1) Pre-existing diabetes mellitus; 2) Clinic blood pressure > 160/100 mmHg; 3) Regular treatment with doses of prednisolone > 5 mg daily; 4) Treatment with prednisolone > 15 mg/day for > 5 days, for any reason within 3 months prior to inclusion; 5) Average change in eGFR of > 5 mL/min estimated over 3 months prior to screening; 6) Blood tacrolimus level continuously outside target range; 7) Known allergy towards study medication; 8) Treatment with any type of statin as secondary prophylaxis following a cardiovascular event; 9) Prior, severe reaction to or severe side effect from any type of statin; 10) Active or chronic liver disease with serum concentration of ALAT > thrice the upper limit of normal (ULN), or spontaneous INR > 1,5; 11) Pre-existing myositis; 12) Plasma CK concentration > 4 times the ULN; 13) Hereditary galactose intolerance or known glucose/galactose malabsorption; 14) Any other organ transplantation prior to or during the trial; 15) Pregnancy or breastfeeding or unable or unwilling to use secure contraception to avoid pregnancy (female participants only); 16) Inability to understand the spoken and written information given and/or inability to give informed consent; 17) Being under legal guardianship, STUDY 2: 1) Pre-existing diabetes mellitus; 2) Clinic blood pressure > 160/100 mmHg; 3) Treatment with antidiabetic medication, other than SGLT2-inhibitors for cardio- or renal protective purposes only, and GLP-1 analogs for weight reduction purposes only; 4) Treatment with glucocorticoids or other immunosuppressive medication of any kind; 5) Known allergy towards study medication; 6) Treatment with any type of statin as secondary prophylaxis following a cardiovascular event; 7) Prior, severe reaction to or severe side effect from any type of statin; 8) Active or chronic liver disease with serum concentration of ALAT > thrice the ULN, or spontaneous INR > 1,5; 9) Pre-existing myositis from any cause; 10) Plasma CK concentration > 4 times the ULN; 11) Hereditary galactose intolerance or known glucose/galactose malabsorption; 12) Any organ transplantation prior to or during the trial; 13) Pregnancy or breastfeeding or unable or unwilling to use secure contraception to avoid pregnancy (female participants only); 14) Inability to understand the spoken and written information given and/or inability to give informed consent; 15) Being under legal guardianship
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